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U.S. Department of Health and Human Services

About FDA

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OCD FY2004 Part 1. Technology and Innovations - CDRH Strategic Goal: Public Health Impact

 Bringing New Products to the Market

In FY 04 CDRH approved or cleared thousands of devices used to diagnose or treat a wide variety of medical conditions, including:

  • Philips HeartStart Home OTC Defibrillator - the first over-the-counter AED cleared by FDA for lay users.
  • ImageChecker® CT CAD Software System - the first image analysis system designed to help radiologists review computed tomography (CT) images of the chest to aid in the detection of solid nodules in the lungs.
  • DeBakey VAD® Child - the first miniaturized heart pump (ventricular assist device) approved for use in children aged 5 to 16 who are awaiting a heart transplant.
  • QuickELISA Anthrax-Pa Kit - the first rapid serum antibody test for anthrax.
  • NeoGram Amino Acids and Acylcarnitine Tandem Mass Spectrometry Kit - the first pediatric device for neonatal screening for general inborn errors of amino acid metabolism.
  • CellSearch™ Epithelial Cell Kit / CellSpotter™ Analyzer - a new biomarker for determining survival in patients being treated for end stage breast cancer.
  • OraQuick® Advance Rapid HIV-1/2 Antibody Test - the first point of care test for this antibody and the first test suitable for general field use.
  • CEDIA® Sirolimus Assay - the first assay for a new immunosuppressive drug in over a decade.
  • Ventana® Medical Systems' PATHWAY Anti-c-KIT (9.7) Primary Antibody - the first IHC marker to assist in diagnosis and treatment selection in patients with a rare GI tumor.

These devices are examples of technology for new indications approved or cleared during this past fiscal year that have a particular impact on patient care.

Benign Prostatic Hyperplasia

Prolieve™ - Approved February 2004, Prolieve™, manufactured by Celsion Corporation, is a transurethral microwave therapy (thermodilalation) system that uses microwave energy to treat Benign Prostatic Hyperplasia (BPH), a non-cancerous enlargement of the prostate gland that commonly affects men over the age of 50. The Prolieve™ device is intended to treat the symptoms of BPH by compressing and heating prostatic tissue that may be blocking the flow of urine. Prolieve™ consists of a permanent instrument and a single-use procedure kit. Prolieve™ delivers microwave energy to the prostate with simultaneous balloon-administered compression (thermodilatation) for 45 minutes. The device provides a non-surgical, minimally invasive treatment of symptomatic BPH in men with a prostate volume of 20 to 80 grams, and in whom drug therapy (e.g., Proscar®) is typically indicated. Prolieve™ may reduce the primary symptoms of BPH that include incomplete bladder emptying, frequent urination, urinary intermittency, urgency, a weak stream, straining to urinate and excessive urination at night (nocturia). Prolieve™ has also been demonstrated to improve peak flow rate, quality of life, post-residual volume, and other disorders associated with urination.

Bone Graft

INFUSE® Bone Graft - Approved April 2004, the INFUSE® Bone Graft, by Wyeth Pharmaceuticals, is intended to be used along with an intermedullary nail (IM nail) to help heal bone fractures of the lower leg or tibia. The INFUSE® device consists of two parts: a genetically-engineered human protein (rhBMP-2) to stimulate bone healing, and an absorbable collagen sponge made from cow (bovine) collagen that is soaked with protein. A metal rod, called an intermedullary nail or IM nail, is surgically implanted inside the tibia bone to stabilize the fracture. The INFUSE® device is implanted at the fracture site to help the bone heal. The device is intended to be used along with internal stabilization (an IM nail) to help heal a fresh, open fracture of the tibia.

Breast Cancer

CellSearch™ Epithelial Cell Kit / CellSpotter™ Analyzer - The CellSearch™ Epithelial Cell Kit / CellSpotter™ Analyzer by Veridex, LLC, a Johnson and Johnson company, was cleared for marketing in January 2004. The CellSearch™ Epithelial Cell Kit / CellSpotter™ Analyzer is intended to be used on breast cancer patients to monitor and to help determine the effectiveness of the cancer treatment. The CellSearch™ Epithelial Cell Kit helps the pathologist identify Circulating Tumor Cells (CTC) in the blood. The CTC are then counted by the pathologist with the aid of the CellSpotter™ Analyzer. The more CTC there are in the blood, the less effective the cancer treatment is believed to be.

Cardioveters, Defibrillators and Pacing Systems

Philips HeartStart Home OTC Defibrillator - The HeartStart Home Defibrillator, manufactured by Philips Medical Systems, is a small, lightweight Automatic External Defibrillator (AED) specifically designed for use without a prescription. Approved September 2004, the device shocks the heart to restore rhythm in patients with life threatening cardiac rhythms. The HeartStart home defibrillator is cleared for use on adults or on children who are at least eight years old or older or who weigh at least 55 pounds. Special small pads are available by prescription for pediatric use. This device is the first over-the-counter AED cleared by FDA for lay users.

 Guidant Cardiac Resynchronization Therapy Defibrillators (COMPANION trial) - The Guidant CONTAK CD, CONTAK CD2, RENEWAL, and RENEWAL 3, manufactured by Guidant Corporation, are Implantable Cardioverter Defibrillators (ICDs) that also deliver Cardiac Resynchronization Therapy (CRT). These ICDs received approval in September 2004. These devices use small electrical impulses to coordinate heart rhythm and improve blood pumping ability in certain patients with moderate to severe heart failure. A Guidant CRT-D delivers CRT to help coordinate the beating of the heart, and may deliver a shock that could return the heart to a live-saving heart rhythm. Together, these two therapies may reduce the combined risk of death or first hospitalization as well as the risk of death alone. These devices also may relieve some of the symptoms associated with heart failure, thus resulting in an improved quality of life.

St. Jude Medical® Epic™ H F and Atlas® + HF Dual Chamber Implantable Cardioverter Defibrillator Systems with Cardiac Resynchronization Therapy - Approved June 2004, the Epic HF and Atlas + HF ICD Systems, manufactured by St. Jude Medical, Inc., are ICDs that also deliver CRT in patients with advanced heart failure. The systems consist of two parts: a pulse generator containing a battery and electronic circuitry, and three insulated lead wires that connect to the pulse generator. The pulse generator is usually implanted below the collarbone, just beneath the skin. One lead is placed in an upper heart chamber (the right atrium) and the two other leads are placed in each of the lower heart chambers (the ventricles). When the device functions as an ICD, it senses dangerous abnormal heart rhythms and shocks the heart back into a normal rhythm. The CRT portion of the device coordinates the beating of the left and right ventricles so that they work together more effectively to pump blood throughout the body. The Epic™ HF and Atlas® + HF Systems should only be used with patients at risk for life-threatening cardiac rhythm problems who also have symptoms of advanced heart failure despite taking heart failure medication.

Stelid II, Stelix, and Stelix II Steroid Eluting Endocardial Pacing Leads - Approved June 2004, the Stelid II, Stelix and Stelix II endocardial pacing leads, manufactured by ELA Medical, S.A., are surgically implanted wires that connect the heart to an implanted pacemaker. The lead allows a pulse generator (pacemaker) to monitor the heart as it slowly releases a steroid (Dexamethasone Sodium Phosphate) into the body. The type of lead chosen is dependent on the pacing needs of the patient. A lead is inserted through a large vein connected to the heart. The leads have different methods of attachment depending on where the leads are being placed in the heart. The Stelid II leads (upper left) have a sharp prong tip (tine) that is inserted into the wall of a lower chamber of the heart (ventricle). The Stelix and Stelix II leads (upper right) are placed against the wall of the upper chamber of the heart (atrium). Once leads are placed in the heart and connected to an implanted pacemaker, the leads detect and transmit electrical signals from the heart to the attached pacemaker, and the pacing output from the pacemaker is sent through the leads to the heart. The steroid, Dexamethasone Sodium Phosphate (< 1.0 mg), located on the tip of the lead, is slowly released into the body. The Stelid and Stelix leads, along with the pacemaker, provide pacing threshold, pacing impedance, and sensing threshold values that are equivalent to controls with adverse event rates similar to control leads. The Stelix and Stelix II leads have equivalent or better electrical performance than controls and similar or fewer adverse events than controls.

St. Jude Medical Frontier™ Biventricular Cardiac Pacing System - Approved May 2004, the St. Jude Frontier™ Biventricular Cardiac Pacing System, by St. Jude Medical, includes the Frontier™ Model 5508 and 5508L Pulse Generators and the Aescula™ LV Model 1055K Lead. The system is used to maintain simultaneous contraction of the lower chambers of the heart (left and right ventricles) following an atrial-ventricular (AV) nodal ablation for irregular heart rhythm such as chronic atrial fibrillation. The device consists of two parts: a pulse generator (pacemaker) containing a battery and electronic circuitry, and three insulated lead wires that connect to the pulse generator. The Frontier™ System should only be used to maintain simultaneous contraction of the lower heart chambers in patients who have undergone an AV nodal ablation for chronic atrial fibrillation, and who have mild to moderate heart failure.

CONTAK® RENEWAL™ TR Models H120 and H125 - Approved January 2004, the CONTAK® RENEWAL™ TR Models H120 and H125, by Guidant Corporation, are implantable pulse generators (IPG) that deliver cardiac resynchronization therapy (CRT). The CRT portion of the device uses small electrical pulses to coordinate the heartbeat and improve blood pumping ability in patients with moderate to severe heart failure. The CONTAK® RENEWAL™ TR system is used in patients who have an electrical disturbance resulting in an irregular heart rhythm (arrhythmia) with moderate to severe heart failure that is not successfully treated with medication. The CONTAK® RENEWAL™ TR system may improve the quality of life for a patient by relieving some of the symptoms associated with heart failure.

Computed Tomography

ImageChecker® CT CAD Software System - In July 2004, FDA approved the ImageChecker CT CAD software system, manufactured by R2 Technology, Inc. The device is a new image analysis system designed to help radiologists review computed tomography (CT) images of the chest. The software system, the first-of-its-kind for use with CT chest exams, aids in the detection of solid nodules in the lungs. This is important because some lung nodules can be malignant. The system uses computer aided detection (CAD) software to analyze CT images that the radiologist has previously reviewed, highlighting areas of the image that appear to be solid nodules. Because the device works independently of the radiologist, it can detect suspect areas that the radiologist may have over looked.

Endoscopic and Surgical Instruments

Da Vinci Endoscopic Instrument Control System - In July 2004, FDA cleared for marketing a robotic-like system to assist in coronary artery by-pass surgery. This device allows direct access to the chest using a standard open chest technique (sternotomy) or through a smaller surgical incision (thoracotomy). The Da Vinci Endoscopic Instrument Control System, manufactured by Intuitive Surgical Inc., enables a surgeon to perform heart surgery remotely while seated at a console with a computer and video monitor.

CoSeal™ Surgical Sealant - Approved December 2003, the CoSeal™ Surgical Sealant, manufactured by Baxter Healthcare Corporation, is a surgical sealant used to help stop leaks in blood vessels. It is made from two kinds of Polyethylene Glycol (PEG), the two PEGs are mixed together as they are applied during surgery to form a glue-like product, which seals leaks around sutures (surgical stitches), staples or other mechanical closure devices used in natural or artificial blood vessels (grafts).

Heart, Ventricular Assist

Syncardia Temporary CardioWest™ Total Artificial Heart (TAH-t) - The Syncardia Temporary CardioWest Total Artificial Heart (TAH-t), by SynCardia Systems, Inc., was approved in October 2004. The device is indicated for use in hospitalized heart transplant-eligible candidates at risk of imminent death from biventricular heart failure. The device may also improve kidney and liver functions because it restores blood flow to these vital organs—hence, making the patient a better candidate for eventual heart transplantation.

DeBakey VAD® Child – In February 2004, FDA approved the DeBakey VAD® Child by MicroMed Technology, Inc. under the Humanitarian Device Exemption (HDE) program. The DeBakey VAD® Child is intended for both home and hospital use in children who are between 5 and 16 years old, and who have end-stage left ventricular failure requiring temporary mechanical blood circulation until a heart transplant can be performed. The device may allow children with severe left ventricular failure to survive long enough to receive a donor heart.

Contegra® Pulmonary Valved Conduit, Models 200 (unsupported) and 200S (supported) - The Contegra® Pulmonary Valved Conduit, Models 200 (unsupported) and 200S (supported), manufactured by Medtronic Heart Valves, were approved in November 2003 as HDE devices. The pulmonary valved conduit device is a bioprosthetic (prosthesis made from biological material) heart valve made from a segment of bovine jugular vein that is treated with preservatives to keep it durable, flexible, and sterilized for human implantation. The Contegra Pulmonary Valved Conduit functions like a natural pulmonary valve. Three leaflets flap open to permit blood flow from the right ventricle into the pulmonary artery and then to the lungs. In conjunction with the three other heart valves (tricuspid, aortic, and mitral), this device controls the direction of blood flow through the chambers of the heart. The device can be used in children and young adults under the age of 18 to correct or reconstruct the outflow of the right ventricle due to congenital heart malformations. It also can be used as a replacement for previously implanted but dysfunctional pulmonary homografts (valves from human cadavers) or valved conduits. Surgical replacement of the affected valve may improve a patient’s medical condition and quality of life.

In Vitro Diagnostics

Ventana® Medical Systems' PATHWAY Anti-c-KIT (9.7) Primary Antibody - Approved August 2004, the PATHWAY Anti-c-KIT (9.7) Primary Antibody, manufactured by Ventana® Medical Systems, Inc., contains an antibody used in a laboratory test that can help identify patients with gastrointestinal stromal tumors (GISTs) and select patients eligible for treatment with the FDA approved cancer drug Gleevec®/ Glivec® (imatinib mesylate). The antibody is used with an automated tissue staining system or manual assays and specialized staining accessories by a doctor trained to identify diseases, a pathologist, who analyzes tissue samples from patients suspected of having GISTs. The antibody detects a protein in the body that stimulates cancerous tissue cell growth (c-KIT tyrosine kinase). The presence of this protein, in association with other clinical information, indicates a diagnosis of cancer and eligibility for GISTs cancer treatment with Gleevec®/Glivec®.

NeoGram Amino Acids and Acylcarnitine Tandem Mass Spectrometry Kit – In August 2004, FDA cleared for marketing the NeoGram Kit. The kit is a laboratory blood test that will help doctors screen newborn infants for a variety of inherited diseases. The kit helps detect inborn errors in metabolism by measuring levels of amino acid, free carnitine and acylcarnitine. Abnormally high amounts of these substances, or abnormal patterns, may indicate different disease states including, but not limited to, phenylketonuria (PKU), maple syrup urine disease (MSUD), medium chain Acyl-CoA dehydrogenase deficiency (MCAD), isovaleric acidemia, homocystinuria and hereditary tyrosinemia. These diseases can result in developmental delay, seizures, mental retardation and death. Early identification may significantly improve long term outcome and quality of life.

CEDIA® Sirolimus Assay - Approved July 2004, the CEDIA® Sirolimus Assay, manufactured by Microgenics Corporation, is a laboratory test that can be used to measure concentration of the drug sirolimus in blood. Approved through the new de novo application process, this is the first new diagnostic test for an immunosuppressive drug developed in almost a decade. This test is used as an aid in the treatment of kidney transplant patients taking sirolimus and is the first FDA cleared sirolimus assay using immunoassay technology available in most central laboratories. Until now, sirolimus tests were performed only by specialized reference laboratories. Rapid monitoring of patients ensures proper treatment and helps in maintaining the integrity of transplanted organs. The assay is used together with other laboratory tests and patient evaluations to help determine if a patient is receiving an appropriate amount of sirolimus. The assay should not be used alone to make treatment decisions. It should be used in conjunction with clinical evaluation and other laboratory tests. Review of this product was followed by publication of a special controls guidance document to assist other sponsors in bringing like products to market. The assay can be used in kidney transplant patients who are taking sirolimus, at any time when estimating the blood level of sirolimus might help manage treatment.

bioMerieux VIDAS Total PSA Assay - Approved July 2004, the Vidas TPSA assay, by bioMerieux Inc., is an in vitro diagnostic test that measures Total Prostate-Specific Antigen (TPSA) in a blood sample. Prostate Specific Antigen (PSA) is an enzyme produced the prostate gland. Healthy men have low concentrations of PSA in their blood. This test is useful in the detection of prostate cancer in men aged 50 years and older, when used with digital rectal exam (DRE), an exam of the size and texture of the prostate.

OraQuick® Advance Rapid HIV-1/2 Antibody Test – In June 2004, FDA granted a Clinical Laboratory Improvement Amendments (CLIA) waiver to the oral HIV test by Orasure Technologies (approved by CBER). The waiver extended the availability of the OraQuick Rapid HIV-1/2 Antibody Test from 38,000 laboratories permitted to perform the test to more than 100,000 sites, including physician offices, HIV counseling centers and community health centers. It is estimated that thousands of patients with undetected HIV infections will have increased access to testing and that earlier and broader identification will now be possible. This should allow for earlier treatment and better efforts to prevent spread of this disease.

QuickELISA Anthrax-Pa Kit - The Anthrax QuickELISA test kit, cleared for marketing in June 2004, detects antibodies produced during infection with Bacillus Anthracis, the bacteria that causes anthrax. The test, manufactured by Immunetics Inc., provides an easy-to-use clinical laboratory tool for assessing whether patients have been infected with anthrax, a serious potential bio threat pathogen.

Glucatell™ - Approved May 2004, Glucatell™, manufactured by Associates of Cape Cod Inc., is a blood test used in a medical laboratory or hospital, to help diagnose severe fungal infections. The Glucatell™ test kit tests for Beta-glucan in the blood. Beta-glucan is found in the blood of patients who may have fungal infections or in patients that are at an increased risk for fungal infections (such as cancer, AIDS, or organ transplants). The serum, or liquid part of the blood is placed in a test chamber and chemicals are added that change color of the serum if Beta-glucan is present. If the test results are positive, doctors can perform other tests to determine what type of fungus is causing the infection. This test will not diagnose infections from types of fungus that do not produce Beta-glucan.

AxSYM Free PSA - Manufactured by Abbott Laboratories, the AxSYM Free PSA was approved in February 2004. The AxSYM Free Prostate Specific Antigen (free PSA) test is typically performed along with a total Prostate Specific Antigen (total PSA) test and a Digital Rectal Exam (DRE) to help distinguish between cancerous and non-cancerous (benign) prostate conditions. The free PSA test measures the amount of PSA that is not attached to other substances (free-floating) in the blood. The total PSA test measures the amount of PSA that is attached to proteins in the blood as well as the PSA that is in the free-floating form. Once both tests are completed, a doctor compares the free PSA result to the total PSA result to determine the percent free PSA (% free PSA). The % free PSA, combined with the total PSA value and a DRE, helps determine whether a prostate biopsy is needed to rule out the risk (in percent) of cancer. The smaller the % free PSA, the more likely the patient is to have prostate cancer. When used with a total PSA test and DRE, the AxSYM Free PSA test can help determine the risk of prostate cancer. The use of % free PSA is expected to reduce the number of unnecessary biopsies, while identifying those men who have an increased probability of having prostate cancer.

DakoCytomation EGFR pharmDx™ - Approved February 2004, the DakoCytomation EGFR pharmDx™, by DakoCytomation California, Inc., is used to identify colorectal cancer patients eligible for treatment with the cancer drug, ERBITUX™ (cetuximab). The EGFR pharmDx™ is a kit used by pathologists to analyze colon tissue samples. The kit detects protein in the body that stimulates cancerous tissue cell growth (Epidermal Growth Factor Receptor or EGFR). The presence of this protein indicates a patient is eligible for colon cancer treatment with ERBITUX™.

Heartsbreath - Approved as a HDE device in February 2004, Heartsbreath, manufactured by Menssana Research, Inc., is a breath test that is used along with a traditional heart (endomyocardial) biopsy on heart transplant recipients who have been transplanted less than one year. This test measures possible organ rejection in heart transplant recipients by measuring the amount of methylated alkanes (natural chemicals found in the breath and air) in a patient’s breath. The Heartsbreath test may be used along with heart biopsy results to help guide short term and long term medical care of heart transplant recipients. The test’s greatest potential value may be in identifying less severe organ rejection (grades 0, 1, and 2) from more severe rejection (grade 3).

Factor II (Prothrombin) G20210A Kit and Factor V Leiden Kit – In December 2004, FDA approved, through the new de novo application process, the first DNA-based laboratory tests for detection of genetic abnormalities in Factor V Leiden and Factor II (prothrombin) genes. The tests, manufactured by Roche Diagnostics Corp, are used in persons who have a history of abnormal blood clots or whose relatives have such a history. Factor V Leiden, is the most commonly tested genetic disorder in the US. Factor II, although less common, is also an important cause for blood clots. Availability of these tests allows routine laboratories to use standardized methods for rapid diagnose and better treatment for patients with these very important genetic disorders. Review of this product was followed by publication of a special control guidance document to assist companies in bringing future like products to market.

In Vitro Diagnostics- Hepatitis

ADVIA Centaur® Anti-HBs ReadyPack Reagents and Calibrators - Approved in September 2004, the Anti-HBs ReadyPack Reagents and Calibrators, by Bayer HealthCare LLC, are part of a laboratory test that detects antibodies to the Hepatitis B virus surface antigen (anti-HBs). Antibodies are produced by the body to fight against foreign substances called antigens, such as the Hepatitis B virus (HBV). The purpose of this test is to determine if the patient has been previously infected with HBV or is immune to HBV infection. This test is performed after vaccination against HBV or following an active infection. This test is intended to be only used on the Bayer ADVIA Centaur® System.

ADVIA Centaur® HBc IgM ReadyPack Reagents and ADVIA Centaur® HBc IgM ReadyPack Quality Control Materials - The ADVIA Centaur® HBc IgM ReadyPack Reagents and ADVIA Centaur® HBc IgM ReadyPack Quality Control Materials, by Bayer HealthCare LLC, were approved in August 2004. The reagent pack is a laboratory test that detects early antibodies associated with Hepatitis B virus (HBV) infection. IgM antibody to Hepatitis B core antigen (anti-HBc IgM) is an early antibody that normally appears during an HBV infection. Along with other tests for HBV infection, this test is used to follow the course of an HBV infection. The test is intended to be only used on the ADVIA Centaur® Immunodiagnostic system. The calibrator is a reagent that is used to set the analyzer so that it may distinguish between positive and negative results. This test helps to determine the stage of infection and what treatment may be needed. Depending on the results of this test and other testing the doctor may recommend anti-viral treatment.

VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and VITROS Immunodiagnostic Products Anti-HBc IgM Calibrator - The VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and VITROS Immunodiagnostic Products Anti-HBc IgM Calibrator, by Ortho-Clinical Diagnostics, Inc. were approved in March 2004. The reagent pack is a laboratory test that detects early antibodies associated with Hepatitis B virus (HBV) infection. IgM antibody to Hepatitis B core antigen (anti-HBc IgM) is an early antibody that normally appears during an HBV infection. Along with other tests for HBV infection, this test is used to follow the course of an HBV infection. This test is intended to be only used on the VITROS ECi Immunodiagnostic System. This test helps to determine the stage of HBV infection and what treatment may be needed. Depending of the results of this test and other testing, a doctor may recommend anti-viral treatment.

VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and VITROS Immunodiagnostic Products Anti-HBc Calibrator - The VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and VITROS Immunodiagnostic Products Anti-HBc Calibrator, by Ortho-Clinical Diagnostics, Inc. and approved in March 2004, is a laboratory test that detects early and late antibodies associated with Hepatitis B virus (HBV) infection. Antibodies are produced by the body to fight against foreign substances called antigens, such as HBV. This test is used along with other HBV tests to monitor the course of an HBV infection. This test is intended to be only used on the VITROS ECi Immunodiagnostic System. The calibrator is a reagent that is used to set the analyzer so that it may distinguish between positive and negative results. Depending of the results of this test and other testing, a doctor may recommend anti-viral treatment.

Abbott AxSYM® Antibody to Hepatitis C Virus - The Abbott AxSYM® Antibody to Hepatitis C Virus, manufactured by Abbott Laboratories, Inc., was approved in February 2004. The AxSYM® Antibody to Hepatitis C Virus (Anti-HCV) is a laboratory test used to help diagnose patients that may be infected with the Hepatitis C virus (HCV). This test detects antibodies associated with HCV. Antibodies are produced by the body to fight against foreign substances called antigens, such as HCV. The AxSYM® Anti-HCV tests a sample of the liquid part of a patient’s blood (serum) and is analyzed by the AxSYM® System. Results from the AxSYM® Anti-HCV will help a doctor diagnose patients with an HCV infection. Positive results from the AxSYM® Anti-HCV should be followed up with additional tests to confirm past or resolved hepatitis infections from active HCV infections. AxSYM® Anti-HCV is not intended for use in screening blood, plasma or tissue donors because it has not proven effective for this use.

Mammography

Siemens Mammomat Novation DM Full Field Digital Mammography System - In August 2004 FDA approved the Siemens Mammomat Novation DM Full Field Digital Mammography System, by Siemens MedicalSolutions USA, Inc. This device produces pictures of the breast using X-rays instead of film. This process uses detectors that change the X-rays into electrical signals, which are then converted to an image. Digital mammography is used for both screening and diagnosis. From the patient’s perspective, the procedure is the same as with ordinary mammography. The Siemens Mammomat Novation DR Full Field Digital Mammography System (Novation DR) is used with an approved X-ray system, the Siemens Mammomat 3000 Nova mammography system.

Ophthalmic

JSZ Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear - Approved October 2004, the JSZ Orthokeratology (oprifocon A) Contact Lenses, by Szabocsik and Associates, are rigid, gas permeable contact lenses used for orthokeratology, a process that temporarily corrects nearsightedness (myopia). The patient wears these lenses overnight and removes them in the morning. During the day, nearsightedness is temporarily corrected or greatly reduced. This may allow the user to not require the use of glasses or contact lenses during the day.

Verisyse™ Phakic IOL - Approved September 2004, the Verisyse™ phakic intraocular lens (IOL), by Ophtec USA Inc., is a plastic lens that is permanently implanted in the eye and attached to the iris to correct moderate to severe nearsightedness (myopia). It is called a phakic IOL because the eye’s natural lens is retained. The Verisyse™ may improve a patient’s distance vision without glasses or contact lenses.

INTACS® Prescription Inserts for Keratoconus - In July 2004, FDA approved the INTACS® Inserts, manufactured by Addition Technology, Inc. These inserts are two curved, clear plastic segments that are implanted in the perimeter of the cornea to reduce nearsightedness (myopia) and irregular steepening of the cornea (irregular astigmatism) caused by keratoconus. INTACS® Inserts are implanted through a small surgical incision on the perimeter of the cornea. The inserts help restore clear vision in keratoconus patients by flattening and repositioning the cornea. Approved under the HDE program, INTACS® Inserts are intended for patients with keratoconus who are no longer able to achieve adequate vision using contact lenses or glasses and for whom corneal transplant is the only remaining option. INTACS® Inserts may restore functional vision and postpone the need for a corneal transplant.

Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear - Approved June 2004, the Euclid Systems Orthokeratology (oprifocon A) Contact Lenses, by Euclid Systems Corporation, are rigid gas permeable contact lenses used for orthokeratology, a process that temporarily corrects nearsightedness (myopia). The patient wears these lenses overnight and removes them in the morning. During the day, nearsightedness is temporarily corrected or greatly reduced. The Euclid Systems Orthokeratology (oprifocon A) Contact Lenses apply slight pressure to the center of the cornea, causing it to temporarily flatten. The flattened cornea redirects light onto the back surface of the eye (the retina) at an angle that can compensate for nearsightedness. Since the cornea is elastic, it gradually regains its shape throughout the day causing nearsightedness to return. Usually, patients must wear the lenses every night to maintain corrected vision.

Oculaid™ Capsular Tension Ring, or Stableyes™ Capsular Tension Ring - A first-of-a-kind device, approved in April 2004, the Capsular Tension Ring (CTR), by Ophtec USA, Inc., helps surgeons place and center an artificial intraocular lens in cataract patients who have weakened or missing zonules, the fibers of the eye that hold the lens in place.

Morcher Endocapsular Tension Ring - The Morcher Endocapsular Tension Ring, Types 14, 14A and 14C, manufactured by Morcher GmbH, were approved in October 2003. An Endocapsular Tension Ring (CTR) assists the cataract surgeon in placing and centering an intraocular lens, artificial lenses implanted to restore clear vision when the clouded natural lens is removed during cataract surgery. The device provides additional support to the capsular bag that surrounds the eye’s lens. The CTR is intended for use in patients who have weakened or missing zonules, thin tissue fibers that hold the lens in place, supporting the capsular bag of the eye.

WaveLight ALLEGRETTO WAVE™ Excimer Laser System - The WaveLight ALLEGRETTO WAVE™ Excimer Laser System, manufactured by WaveLight Laser Technologies AG, was approved in October 2003. The device is a refractive excimer, or heatless, laser system that uses invisible ultraviolet (UV) light pulses to remove precise amounts of corneal tissue from the eye to reduce or eliminate farsightedness and astigmatism.

Osteoarthritis

Orthovisc® High Molecular Weight Hyaluronan - Approved February 2004, the Orthovisc® High Molecular Weight Hyaluronan, manufactured Anika Therapeutics, Inc., is a solution of sodium hyaluronate, a viscous substance that is naturally present in the knee joint. A doctor injects ORTHOVISC® into knee joints to relieve pain from osteoarthritis (OA) of the knee. ORTHOVISC® is used to treat pain from OA of the knee in patients who have not responded to pain reduction drugs like acetaminophen and non-drug treatments such as exercise and physical therapy.

Prostheses

Vertical Expandable Prosthetic Titanium Rib (VEPTR) - Approved August 2004 as a HDE device, the Vertical Expandable Prosthetic Titanium Rib (VEPTR), manufactured by Synthes Spine Co., is a surgically implanted device used to treat Thoracic Insufficiency Syndrome (TIS) in pediatric patients. TIS is a congenital condition where severe deformities of the chest, spine, and ribs prevent normal breathing and lung growth and development. The VEPTR device is a curved metal rod that is attached to ribs near the spine using hooks located at both ends of the device. The VEPTR device helps straighten the spine and separate ribs so that the lungs can expand and fill with sufficient air to breathe. The length of the device can be adjusted as the patient grows.

Oxford™ Meniscal Unicompartmental Knee System - Approved April 2004, the Oxford™ Meniscal Unicompartmental Knee System, by Biomet Orthopedics, Inc., is an artificial mobile bearing knee system that replaces one side of the knee joint. The system has three parts: a metal curve-shaped part (femoral component), which a doctor cements onto the end of the thigh bone, a flat metal “tray” that is cemented onto the top of the shin bone (tibia), and a plastic support (bearing) that sits on the tray and joins with the curved femoral component. The plastic bearing slides in between the tibial tray and femoral component, which allows the artificial knee joint to move. The Oxford™ Meniscal Unicompartmental Knee System reduces pain by replacing the painful arthritic portion of the knee joint, and restores movement of the knee joint.

Keramos™ Ceramic/Ceramic Total Hip System - The Keramos™ Ceramic/Ceramic Total Hip System, manufactured by Encore Medical, LP, was approved in November 2003. The device is an alumina ceramic artificial hip replacement system, surgically implanted to completely replace a diseased hip joint. The system has four parts that work together to allow the hip joint to move: a metal hip stem that is placed into a hole drilled in the end of the thigh bone; a ceramic, ball-shaped part (femoral head) that fastens to the metal hip stem; a ceramic, socket-shaped part (acetabulum) that the ball-shaped part fits in; and a metal shell that fastens the ceramic socket-shaped part to the hip bone. The ceramic ball slides around in the ceramic socket, allowing the artificial hip joint to move. The Keramos™ Ceramic/Ceramic Total Hip System is intended for patients who need a total hip replacement because of painful inflammatory or non-inflammatory arthritis.

Skin Fillers

Sculptra – In August 2004, after an expedited review, FDA approved Sculptra, manufactured by Dermik Laboratories, for use in human immunodeficiency (HIV) patients. Sculptra is an injectable filler intended to correct facial fat loss in HIV infected patients. The filler is the first such treatment approved for a condition known as lipoatrophy, or facial wasting, a sinking of the cheeks, eyes and temples caused by the loss of fat tissue under the skin. Lipoatrophy is common among HIV patients. FDA expedited review of the product because of its importance to people with HIV/AIDS.

Hylaform - Approved April 2004, Hylaform gel, by Genzyme Corporation, is a sterile colorless skin (dermal) filler made of chemically modified hylauronic acid derived from an avian source. Hylauronic acid is a naturally occurring substance found in cell and tissue fluids that is chemically, physically, and biologically similar in the tissues of all species. Hylaform gel is made from purified, natural hylauronic acid that is gradually absorbed by the body. Hylaform is injected by a doctor into facial tissue where moderate to severe facial wrinkles and folds occur. The gel temporarily adds volume to the skin and can give the appearance of a smoother face.

Restylane® Injectable Gel - The Restylane® Injectable Gel, by Q-Med Scandinavia, Inc., was approved in December 2003. Restylane® is a transparent hyaluronic acid gel that is injected into facial tissue to smooth wrinkles and folds, especially around the nose and mouth. The gel works by temporarily adding volume to facial tissue. Its effect lasts for about 6 months. Restylane® is intended for use in areas of facial tissue where moderate to severe facial wrinkles and folds occur.

Spinal

PRECISION™ Spinal Cord Stimulator (SCS) System - Approved in April 2004, the PRECISION™ Spinal Cord Stimulator (SCS) System, by Advanced Bionics Corporation, is a neurostimulation device that transmits electrical signals to the spinal cord to decrease chronic pain in the body, arms and legs. The device consists of two parts: a stimulator device (signal generator) implanted under the skin that transmits electrical signals to the spinal cord through an insulated lead wire; and an external remote control that programs the treatment delivered by the signal generator. The Precision™ SCS System is used as an aid in the management of difficult to treat chronic pain of the body and limbs, pain associated with failed back surgery syndrome, low back pain, and leg pain. The Precision™ SCS System may decrease difficult to treat chronic pain in the body, arms, and legs.

OP-1 Putty - Approved April 2004 under the HDE program, the OP-1 Putty by Stryker Biotech, is used to make a new posterolateral spinal fusion in patients who have had a failed posterolateral spinal fusion. OP-1 Putty is made from a manufactured (genetically engineered) human protein powder, cow (bovine) collagen that is mixed with a sterile salt water (saline) solution, and a thickening agent to form a putty-like material. During surgery, the putty is placed on each side of the spinal levels that need to be fused. OP-1 Putty may help form a spinal fusion in patients who have failed a previous spinal fusion surgery, and are not able to provide their own bone or bone marrow for grafting because of a condition such as osteoporosis, diabetes, or smoking.

Stents

ACCULINK™ and RX ACCULINK™ Carotid Stent System - In August 2004, FDA approved the ACCULINK system, manufactured by Guidant Corporation. This device consists of two systems: a stent and delivery catheter system (ACCULINK™ and RX ACCULINK™ Carotid Stent System) and an embolic protection system (ACCUNET™ and RX ACCUNET™ EPS). The stent is a metal mesh tube placed on a delivery catheter. The embolic protection device is a micromesh filter basket on the end of a delivery catheter that catches any particles that may break off from the blockage during the procedure. FDA approved the stent for use in opening blocked arteries in the neck. The stent is intended to prevent stroke by treating blockages in the carotid artery, the main blood vessel leading to the brain. This first-of-a-kind device was approved for use in patients who have had symptoms of a stroke or whose carotid artery is at least 80 percent blocked, and who are not good candidates for the surgical alternative. The device is inserted during angioplasty, a less invasive procedure in which the stent is threaded up to the neck artery via a catheter inserted in the groin. Patients usually require only local anesthesia during placement of the stent.

IntraStent® DoubleStrut™ Stent - The IntraStent® DoubleStrut™ Stent, manufactured by ev3 Inc., is a thin, flexible metal mesh tube that can be implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries). Approved June 2004, the IntraStent® acts like a scaffold by holding an iliac artery open to maintain adequate blood flow. The IntraStent® is used to treat patients with iliac artery narrowing caused by atherosclerosis.

TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire) – In March 2004, FDA approved the TAXUS Express2™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire), manufactured by Boston Scientific Corporation. The device is the second drug-eluting stent approved to open clogged coronary arteries.

 NIRflex™ Premounted Coronary Stent System - The NIRflex™ Premounted Coronary Stent System, manufactured by Medinol Ltd., was approved in October 2003. The Coronary Stent System (CSS) consists of an expandable stainless steel tube (a stent), attached to a deflated balloon at the end of a long flexible tube (delivery catheter). The stent is used to open an abnormally narrowed artery by the accumulation of plaque in the artery wall and it becomes permanently implanted to hold open the artery.

Recent Device Approvals

The Recent Device Approvals website, http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/default.htm, contains information on recently approved devices, including:

  • New Device Approvals, including some of the newest medical technology available
  • Monthly listings of Premarket Notification [510(k)] and Premarket Approval (PMA) decisions
  • Information on Humanitarian Device Exemption (HDE) approvals
  • Searchable databases of devices previously approved for marketing or declared substantially equivalent to a legally marketed device.
  • Frequently asked questions about recently approved devices.

 Medical Device Review Programs

CDRH is responsible for the program areas through which medical devices are evaluated or cleared for clinical trials and marketing. Major programs areas include Premarket Approval (PMA), Product Development Protocol (PDP), Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), and Premarket Notification (510k). Information on these programs can be obtained through the Device Advice website, CDRH`s self-service site for medical device and radiation emitting product information (http://www.FDA.Gov/CDRH/devadvice/.)

Major Submissions

In FY 04, CDRH received 8,436 major submissions. During the same period of time, we completed 8,573 major submissions. A breakdown on the number of major submissions received by program area is shown in Table 1. Table 2 lists numbers major submissions completed in each program area.

Table 1. Major Submissions Received (FY 99 – FY 04)

TYPE OF SUBMISSION199920002001200220032004
Original PMAs646771495451
PMA Supplements557546641645666635
Original IDEs304311284312242226
IDE Amendments275240206252216167
IDE Supplements4,1274,3884,8114,7244,4154,312
510(k)s4,4584,2024,2484,3204,2473,635
Original HDE121155109
HDE Supplements41016162929
Total9,8019,77510,28210,3239,8799,064

Table 2. Major Submissions Completed (FY 99 - FY 04)

TYPE OF SUBMISSION199920002001200220032004
Original PMAs364253413139
PMA Supplements440474442533494466
Original IDEs305320284307246221
IDE Amendments268251207251217162
IDE Supplements4,2244,3354,8034,7114,4244,348
510(k)s4,5934,3974,1504,3764,1323,917
Original HDE665626
HDE Supplements31011132423
Total9,8769,8359,95410,2389,5709,182

Premarket workload and performance information is available at the Office of Device Evaluation website, http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm115879.htm, and at the Office of In Vitro Diagnostic Device (OIVD) Evaluation and Safety website, http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm115904.htm.

 Implementation of MDUFMA

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide FDA new responsibilities, resources, and challenges. MDUFMA was signed into law October 26, 2002. On April 1, 2004, the Medical Devices Technical Corrections Act (MDTCA), PL 108-214, was signed into law. MDTCA amends MDUFMA to clarify Congress’s intent and to improve and expand upon some features of MDUFMA. In FY 04, CDRH invested time, attention, and resources on the implementation of MDUFMA.

MDUFMA has four particularly significant features:

  • User fees for premarket reviews of PMAs, PDPs, premarket reports (a new category of premarket application for reprocessed single-use devices), Biologic License Applications (BLAs), certain supplements, and 510(k)s.
  • Performance goals for many types of premarket reviews. These goals become more demanding over time, and include decision goals and cycle goals (cycle goals refer to actions prior to the final action on a submission).
  • Establishment inspections may be conducted by accredited persons (third parties), under carefully prescribed conditions.
  • New regulatory requirements for reprocessed single-use devices, including a new category of premarket submission, the premarket report.

MDUFMA Resources and Performance Goals

CDRH’s medical device review programs benefited from the steady progress the Center has made in developing and deploying process improvements made possible by MDUFMA. Two of MDUFMA’s key provisions are driving the improvements we are showing in our device review programs:

  • User fees for premarket reviews of PMAs, PDPs, premarket reports, real-time PMA supplements, 180-day supplements, and 510(k)s have provided an important revenue stream that has allowed CDRH to increase our review capabilities and capacity by —
    • hiring more reviewers and more scientific, technical, and medical staff;
    • expanding training opportunities for our review staff; and
    • beginning to make long-needed improvements to critical data systems and support infrastructure.
  • Performance goals for many types of premarket reviews have provided us a clear roadmap to where we need to take the program, and benchmarks that allow us to measure our progress over time. These goals were developed collaboratively with industry and Congress, and provide a common framework for measuring our performance. Our goals become more demanding over time, and include FDA decision goals and cycle goals.

MDUFMA has provided the device program much greater visibility, and the support it has garnered from industry, the Administration, and Congress is the primary reason why the President’s Budget for FY 05 proposed, and Congress enacted, an increase of more than $23.8 million (over FY 04) for the medical device program. With increased appropriations and user fees, CDRH will have the means to hire additional staff, expand training opportunities, improve review processes, provide more interactive reviews, provide new and updated guidance documents, rebuild and expand the support infrastructure, begin to lay the foundation for electronic reviews, and much more. MDUFMA makes these improvements possible.

For additional information, including the latest report on progress in meeting MDUFMA’s performance goals, visit www.FDA.Gov/CDRH/mdufma.

During FY 04, CDRH took many actions as we worked to provide guidance, improve our review processes, and build and expand essential data systems and other infrastructure. These actions set the stage for the hard work we face to meet MDUFMA’s FY 05 and later performance goals. Among our most notable actions, we:

  • published 28 Federal Register notices to keep the public informed of our plans and actions in implementing MDUFMA;
  • published 3 new draft guidance documents, 7 new final guidance documents, and 2 updated final guidance documents;
  • held our first annual meeting with MDUFMA stakeholders (covering FY 03),
  • submitted a report to Congress summarizing our performance against MDUFMA’s goals during FY 03; and
  • submitted a report to Congress summarizing the financial position of the MDUFMA program.

The efforts invested in these and similar activities during FY 03 and FY 04 are already producing measurable improvements in the timeliness, predictability, and quality of our device reviews. We are meeting or exceeding our MDUFMA performance goals, and we intend to continue to work towards achieving the more difficult goals for FY 05 through FY 07.

CDRH carefully monitors performance against all of MDUFMA’s performance goals, even those that have not yet gone into effect. At the end of each quarter, we report on all workloads that are, or that eventually will be, subject to a performance goal. We provide information on receipts, actions we have taken, how those actions compare with the applicable performance goal, and other information. Progress to date has been encouraging, particularly the improvement shown for the FY 04 receipt cohort.

MDUFMA Performance Goals

These tables show our progress towards meeting MDUFMA’s performance goals. They provide a comparison of performance for the FY 03 and FY 04 receipt cohort. All key indicators show modest, but consistent, improvement from FY 03 to FY 04. Additional information is available at the MDUFMA website, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm.

Table 3. PMA Performance Goals

 

 Decision Goals 

FY 2006 Goal: 80% of FDA decisions within
320 FDA days

(Decision = approval, approvable, approvable
pending GMP, not approvable, denial)

(as of 9/30/2004)

Cycle Goals 

(as of 9/30/2004)

FY 03 Cohort
  • 47 Original PMAs and P-T Supplements filed
  • 41 FDA decisions; 6 pending applications
    • % of decisions meeting goal: 95%
    • % of cohort meeting goal (to date): 83%
    • % awaiting MDUFMA decision: 13%
  • 25 1st action = major deficiency letter
    • % of actions meeting goal: 84%
    • FY 2005 Goal: 75% within 150 FDA days
  • 22 “all other” 1st actions
    • % actions meeting goal: 96%
    • FY 2005 Goal: 75% 180 FDA days
  • FY 2003 first action cohort is closed
FY 04 Cohort
  • 41 Original PMAs and P-T Supplements filed
  • 11 FDA decisions; 30 pending applications
    • % of decisions meeting goal: 100%
    • % of cohort meeting goal (to date): 27% %
    • awaiting MDUFMA decision: 73%
  • 20 1st action = major deficiency letter
    • % of actions meeting goal: 85%
    • FY 2005 Goal: 75% within 150 FDA days
  • 12 “all other” 1st actions
    • % actions meeting goal: 100%
    • FY 2005 Goal: 75% 180 FDA days
  • 9 with first action pending (22% of cohort)

Table 4. 510(k) Performance Goals

ActionFY03
Performance
FY04
Performance

FY 05 Goal

 

Final decision <90 days76%89%75%
First action <75 days58%78%70%
Second action <60 days50%81%70%
  29% of cohort awaiting
final decision as of
9/30/04
 

New Option for Obtaining Quality Systems Inspections

MDUFMA authorizes FDA-accredited persons to inspect qualified manufacturers of class II and class III devices. These provisions are intended to help FDA focus its limited inspection resources on higher-risk inspections and give medical device firms that operate in global markets an opportunity to more efficiently schedule multiple inspections.

A third-party inspection will cover the same quality systems requirements as an FDA inspection, and will be no less stringent than an FDA inspection. The accredited person who conducts the inspection will report to FDA, and FDA retains the sole responsibility for determining whether a manufacturer is in compliance with FDA’s Quality Systems Regulation and other regulatory requirements, and whether voluntary or official action is required to correct observed deficiencies.

A third-party inspection will provide manufacturers greater control over the timing of their inspection, and because a third-party inspection may be completed in phases over a two-year period, the manufacturer should be able to better coordinate inspection activities with their firm’s normal production practices and better accommodate the schedules of key personnel. If a firm uses a third-party that is both accredited by FDA and recognized by another country, it is possible that a single third-party inspection will meet the requirements of both FDA and another regulatory authority, thereby reducing or eliminating the need for multiple inspections of the same establishment. Manufacturers may also be able to coordinate a third-party inspection with other quality initiatives, such as audits to obtain or maintain ISO 9001:2000 certification.

Strict provisions to prevent conflicts of interest, establishment eligibility criteria, provisions for continued periodic FDA inspections, and careful FDA oversight all work together to ensure the integrity of the third-party inspection program.

During FY 04, we completed the work necessary to launch the third-party inspection program and:

As a result of these actions, manufacturers may choose to obtain a third-party inspection rather than an FDA inspection. We encourage qualified establishments to consider this flexible and innovative option. Additional information on FDA’s third-party inspection program is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ PostmarketRequirements/ThirdPartyInspection/default.htm.

Strengthened Oversight of Reprocessed Single-Use Devices

One of the more important changes made by MDUFMA was to provide FDA with greater oversight authority to help ensure the safety and effectiveness of reprocessed single-use devices. Before enactment of MDUFMA, the regulatory requirements for manufacturers of reprocessed single-use devices (the persons who are reprocessing the device) was dependant upon the class of the device. Manufacturers of reprocessed class I and II single-use devices were required to have a 510(k), unless the device was exempt from 510(k). Reprocessors of class III devices were required to obtain premarket approval.

MDUFMA required us to undertake a comprehensive examination of exemptions from our 510(k) premarket notification requirements. As a result, we revoked many of the past exemptions and 510(k)s are required for some class I and class II reprocessed devices, including devices that were on the market prior to enactment of MDUFMA. Furthermore, the law required “validation data” in new 510(k)s to demonstrate that a reprocessed device will remain safe and effective for each additional intended use. If a reprocessed device was cleared through the 510(k) process prior to MDUFMA, the law also required validation data to be submitted to CDRH or the device could no longer be marketed. Reprocessors of class III devices are required to submit a premarket report (a new type of premarket application that includes requirements that focus on the special characteristics of reprocessed devices).

During FY 04 we:

Additional information on FDA’s oversight of reprocessed single-use devices is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ ReprocessingofSingle-UseDevices/default.htm.

 Medical Devices Advisory Committee

The Center’s Medical Devices Advisory Committee (MDAC) with its 18 panels provides clinical and scientific advice to FDA in a number of areas fundamental to the regulation of medical devices. The primary areas of activity are: (1) review and recommendations on premarket submissions, primarily Premarket Approval Applications (PMAs), and 510(k)s, (2) classification and reclassification of medical devices based on risk to patients, (3) advice on guidance documents that provide industry and FDA staff with expectations for studies and data for premarket reviews, and (4) input on new issues or questions concerning the determination of the safety or effectiveness of medical devices.

In FY04, CDRH held twenty-one panel meetings. These panels reviewed and made recommendations on twenty PMAs, one 510(k), two reclassification petitions, and three general issues. In FY04 there were 20 training sessions for new panel members and consultants. The panels reviewed PMAs for significant device breakthrough technologies such as a computed tomography (CT) computer aided detector (CAD) device for detecting solid pulmonary nodules, a magnetic resonance imaging (MRI) guided uterine fibroid focused ultrasound ablation system and a total artificial heart for use as a bridge to transplant for patients in imminent risk of death.

CDRH continuously recruits and selects highly qualified experts to serve as members and consultants on these panels. Potential candidates are asked to provide detailed information concerning financial holdings, employment as well as research grants and contracts to identify any potential or imputed conflicts of interest. Interested individuals should send their curriculum vitae to njp@CDRH.fda.gov.

The MDAC panels are key to ensuring that the agency has access to the nation’s esteemed medical and scientific experts and to making the FDA medical device review process transparent to stakeholders. The CDRH greatly appreciates the significant contributions that the advisory panel members and consultants make to the ongoing medical device review process.