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About FDA

OCD FY2003: Bringing New Products to the Market

New Leadership

Office of In Vitro Diagnostic Device Evaluation and Safety

The Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) ( InVitroDiagnostics/default.htm) was established on November 17, 2002. OIVD combines the functions of all the offices within the Center for Devices and Radiological Health (CDRH) into one organizational unit for cradle-to-grave regulation of in vitro diagnostic devices (IVDs). Lead by Dr. Steven Gutman, OIVD Director, the Office consists of a multidisciplinary group of scientists and other professionals who are collectively dedicated to promoting and protecting public health through clear and consistent regulation of IVDs by applying good scientific principles throughout the Total Product Life Cycle of the device. OIVD has a dual charge to foster the rapid transfer of good new IVDs into the medical market while preventing marketing of unsafe or ineffective devices.

Medical Device Fellowship Program

To keep pace with the rapid development of new technology, and to make decisions based on the best scientific information and knowledge available, CDRH routinely consults with experts in the academic community, other government entities, clinical practice, and the military. CDRH established the Medical Device Fellowship Program (MDFP) ( MedicalDeviceFellowshipProgramCDRH/default.htm) in 2002 to increase the range and depth of collaborations between CDRH and the outside scientific community. The MDFP offers short- and long-term fellowship opportunities for individuals interested in learning about the regulatory process and sharing their knowledge and experience with medical devices from the relatively simple to the highly complex. The MDFP is also developing professional development opportunities for CDRH staff at universities and hospitals, to help staff stay current with new technology and clinical practice. CDRH’s Medical Device Fellowship Program helps the Center achieve the goal of becoming a “magnet for excellence” by attracting, developing and retaining a highly skilled and diverse workforce to advance public health mission. The MDFP, in turn, supports the agency’s goal of having a strong FDA and objective of ensuring a high quality, diverse and motivated workforce. Under the leadership of Dr. Susan Homire, the program has established Biomedical Engineering Co-op and Engineering Internship Programs with Carnegie Mellon University, Marquette University, University of Iowa, Texas A&M, University of Maryland, Catholic University of America, University of Kansas, Drexel University and George Washington University. Additional academic partners include Medical College of Wisconsin, University of Illinois at Champagne-Urbana, Stanford University, Case Western Reserve University, Uniformed Services University of the Health Sciences, University of Houston, University of Puerto Rico, Howard University and Virginia Tech. Some MDFP participants come to the Center through the National Research Council Associateship Program and the Brigham and Women’s Hospital Resident Exchange Program. The MDFP had 42 participants in FY 03.

Advances in Patient Care

Last year the CDRH approved and cleared thousands of devices used to diagnose and treat a wide variety of medical conditions. Below are highlighted several new medical devices and devices with new indications approved or cleared during this past fiscal year that have a particular impact on patient care.

The Premarket Approval Application (PMA) Approval website describing recently approved devices with patient information is available at ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm.

Left Ventricular Assist Device (LVAD)

HeartMate® SNAP-VE LVAS (Sutures Not Applied-Vented Electric Left Ventricular Assist System) by Thoratec Corporation is the first LVAD approved for long-term implant. It was originally approved for use as a bridge to cardiac transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. It is now also approved for use in patients who are not eligible for cardiac transplantation with New York Heart Association Class IV end stage left ventricular failure who have received optimal medical therapy for at least 60 of the last 90 days, and who have a life expectancy of less than two years. The device system is approved for use both inside and outside of the hospital.

Drug-Eluting Stent

CYPHER™ Sirolimus-eluting Coronary Stent by Cordis Corporation is the first drug-eluting stent for angioplasty procedures to open clogged coronary arteries. The device is an expandable, slotted, stainless steel tube, with a drug (sirolimus) contained within a thin polymer coating on its surfaces. The Stent is mounted over a balloon on the end of a long thin flexible tube called a “delivery catheter” (RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System). This new stent slowly releases a drug, and has been shown in clinical studies to significantly reduce the rate of re-blockage that occurs with existing stents. The device should not be used in patients: who cannot take aspirin or blood-thinning medicine, who have an allergy to the drug sirolimus, its derivatives or the polymers used to coat the stent, or who have a blockage in the coronary artery that will not allow complete inflation of the balloon.

Sterilization Procedure for Women

The Essure™ System by Conceptus, Inc. is a new method of permanent birth control (sterilization) for women. Unlike other sterilization procedures for women, this system does not require incisions or general anesthesia. Instead, a doctor implants small metal coils in a woman’s fallopian tubes by threading them through the vagina and uterus using a specialized delivery catheter. After the catheter is removed, the coils remain in place permanently. Over time, scar tissue forms around the implanted coils and blocks the fallopian tubes, preventing sperm from fertilizing a woman’s eggs. Initial one and two year data from clinical studies showed no pregnancies at the time of approval. Longer term data will be available over time with postmarket follow-up of these patients.

Fibroid Embolization

Uterine Fibroid Embolization by Biophere Medical, Inc. is the first 510(k) cleared for Uterine Fibroid Embolization (UFE). It is indicated to treat noncancerous tumors (symptomatic fibroids). A radiologist makes a small nick in the skin (less than one-quarter inch) and inserts a thin tube (catheter) into the main artery of the thigh (femoral artery). Using X-ray imaging, the radiologist guides the catheter through the femoral artery into the uterine artery. Tiny spheres or particles made of plastic or sponge material the size of grains of sand are pumped through the catheter into the uterine artery on one side of the body, where they block the blood supply to the fibroids. The procedure is then repeated on the other side of the body so the blood supply is blocked in both the right and left uterine arteries. With decreased blood supply, part of the fibroid tissue dies. The overall effect is the shrinking of the fibroid.

Limb Salvage System

Children who require replacement of their knee joints often lose the ability for growth in the affected limb. This necessitates several surgeries throughout childhood and adolescence to expand the child’s prosthesis as the child grows to maintain limb length equality.

The REPIPHYSIS™ Limb Salvage System, manufactured by Wright Medical Technology, Inc., is an artificial knee joint with a unique femoral component that can be expanded without surgical intervention. The device utilizes a coil that fits around the patient’s leg that produces an electromagnetic field (EMF). The EMF induces an electrical current and subsequent heating of an internal wire. The generated heat softens a polymer-locking ring, allowing a slow expansion of an internal compressed spring. The spring expansion pushes the spring housing and femoral housing apart, thus increasing the overall length of the implant.

Deep Brain Stimulator

Medtronic Activa® Dystonia Therapy is a totally implanted brain stimulator to treat long-term primary dystonia (abnormal contraction of muscles at rest) that is not responsive to drug therapy. An implanted pulse generator (IPG) is connected with an insulated wire (a lead) extension, to another lead with four electrodes. The electrodes are in contact with a specific structural area within the brain. The IPG is implanted under the skin of either the abdomen or under the collarbone, and sends programmable electrical stimulation pulses to the electrodes that were implanted in the brain. Two IPG device systems may be implanted, so that both sides of the brain can be stimulated to relieve symptoms on both sides of the body. It may improve some symptoms associated with primary dystonia. However, individual results vary and the specific benefit for an individual cannot be predicted.

Stair-Climbing Wheelchair

The INDEPENDENCE™ iBOT™ 3000 Mobility System by Independence Technology, L.L.C. is a new indoor/outdoor power mobility device for use by people with mobility impairments and the use of at least one upper extremity. It provides mobility on smooth surfaces and inclines at home and in the community; movement over obstacles, uneven terrain, curbs, grass, gravel, and other soft surfaces; mobility in a seated position at an elevated height; ascent or descent of stairs with or without assistance; and transport of the unoccupied wheelchair. Because of its unique balancing mechanism, the device remains stable and the seat stays level under most conditions. The iBOT™ is available by prescription only, from specially trained health professionals.

External Insulin Pump

The Medtronic MiniMed Paradigm Model 512 Insulin Pump and BD Paradigm Link Blood Glucose Monitor by MiniMed, Inc. is an ambulatory, battery operated, rate-programmable microinfusion pump. The Model 512 Insulin Pump is indicated for the continuous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. The BD Paradigm Link Blood Glucose Monitor is an in vitro diagnostic device intended to be used for the quantitative measurement of glucose in whole blood samples obtained from the fingertip, by people with diabetes mellitus in the home, as an aid to monitor the effectiveness of diabetes control. When used together, the glucose monitor can automatically telemeter glucose values to the insulin pump using radio frequency communication. The glucose monitor can also serve as a radiofrequency interface to allow communication between the insulin pump and a personal computer running the appropriate Medtronic MiniMed communications software.

A1cNow® for Home Use

On December 13, 2002, FDA cleared the A1cNow® for Home Use device. This device provides a quantitative measurement of the percent of glycated hemoglobin levels in capillary blood samples. This test is used at home by patients who have diabetes to monitor long-term glycemic control.

Bayer ADVIA Centaur Serum HER-2/Neu Assay

On January 30, 2003, FDA cleared the Bayer ADVIA Centaur Serum ERr-2/Neu Assay used in the follow-up and monitoring of patients with metastatic breast cancer whose initial serum Her-2/neu level is greater than15 ng/ml. Her-2/neu values should be used in conjunction with information available from clinical and other diagnostic procedures in the management of breast cancer. The clinical utility of the measurement of Her-2/neu in serum as a prognostic indicator for early recurrence and in the management of patients on immunotherapy has not been fully established.

Invasive Fungal Infection

On May 16, 2003, FDA cleared The Platelia® Aspergillus EIA test, manufactured by Bio-Rad Laboratories. This is the first rapid laboratory test to detect Aspergillus galactomannan antigen in blood, as an indicator of invasive infection. The test will help doctors diagnose invasive Aspergillus infection, a life-threatening invasive fungal infection that often occurs in leukemia patients, organ and bone marrow transplant patients, and patients whose immune systems are compromised by illness or chemotherapy, much sooner than current laboratory methods. Results are available in about three hours. By comparison, the standard culture method of testing for Aspergillus takes a minimum of four weeks before results are available. Earlier detection means earlier intervention with life-saving treatment for these critically ill patients.

West Nile Virus Infection

On July 3, 2003, FDA cleared the West Nile Virus IgM Capture ELISA test, manufactured by PanBio, Limited. This is the first test for use as an aid in the clinical laboratory diagnosis of West Nile Virus infection. The test is intended for use in patients with clinical symptoms consistent with encephalitis. West Nile virus is a mosquito-borne flavivirus that until 1999 was found only in the Middle East, Eastern Europe and Africa. The disease first appeared in the United States in 1999. In 2002 over 3300 cases were identified. Transmission to humans is primarily by mosquito. While the virus often presents as a mild infection that clears without further treatment, some patients develop severe infection resulting in severe neurological disease and even death. Antibodies for IgM can be seen within the first 1 to 8 days after onset of disease and can assist in the diagnosis of these patients. The disease is most prevalent during the mosquito season which is expected to begin in July and end in October. Over the past several years, the geographic range of the virus as well as the number of new infections has expanded and now covers most of the continental United States. This test will be of use in helping to diagnose this growing public health problem.

Diagnosis of Congestive Heart Failure

On November 19, 2002, FDA cleared the Elecsys proBNP Immunoassay test. This test is a first-of-a-kind fully automated test for diagnosing congestive heart failure. The automation allows the laboratory to run a higher volume of samples, making the test more readily available to patients who need it. The Elecsys proBNP Immunoassay test is made by Roche Diagnostics, Inc. and is run on the Roche Diagnostics Elecsys Analyzers. The test detects the level of a peptide, NT-proBNP, which is secreted almost exclusively by the heart. An elevated level can indicate the presence of congestive heart failure. The higher the blood levels of proBNP, the more serious the condition. FDA cleared the first laboratory test for use as an aid in diagnosing congestive heart failure, the Biosite Diagnostics Triage BNP test in November 2000. The test can help doctors differentiate between congestive heart failure and other problems, such as lung disease. Early detection of congestive heart failure is important because, if detected early, it can often be managed with medication.

Ruling Out Heart Attack

On February 14, 2003, FDA cleared the Albumin Cobalt Binding Test (ACB Test). This test is a new first-of-a-kind blood test that measures Ischemia Modified Albumin (IMA). IMA helps in determining that a patient has NOT had a heart attack when he or she presents to an emergency room with severe chest pain. The ACB Test is manufactured by Ischemia Technologies Inc. It uses human serum and detects IMA by measuring how much cobalt is bound to the blood protein albumin. The ACB Test works by detecting albumin levels. A cobalt solution is added to serum and the unbound cobalt is detected by a color indicator. In the serum of normal patients more cobalt is bound to albumin leaving less cobalt to be detected by the color indicator, and forms less color. In patients with non-normal albumin levels, less cobalt is bound to albumin, which leaves more free cobalt to react with the color indicator, forming more color. The ACB Test is used as an additional test with both electrocardiogram (ECG) and another chemical marker—Troponin. ACB is not intended for use as a stand alone heart attack test. A normal ACB Test with a normal ECG, and a normal Troponin, gives doctors more confidence that patients can go home because they did not have a heart attack.

Monitoring Asthma Better

On April 30, 2003, FDA cleared the Nitric Oxide (NIOX) Test System. This test is a first-of-a-kind, non-invasive test system to measure the concentration of nitric oxide in exhaled human breath. The test system helps make it easier for doctors to monitor a patient’s asthma. The NIOX Test is manufactured by Aerocrine AB of Sweden. It combines equipment that detects nitric oxide and equipment that analyzes exhaled breath with a special computer system. To use the device, a patient places the mouthpiece over his or her mouth. The mouthpiece is connected to the equipment and the computer. A patient inhales nitric oxide-free air to total lung capacity, and then slowly exhales into the mouthpiece. The nitric oxide concentration is then displayed immediately on the computer screen. Doctors can use the device in their offices to evaluate their patient’s response to anti-inflammatory treatment.

Predicting Coronary Heart Disease

On July 18, 2003, FDA cleared the PLAC Test. This test is a first-of-a-kind, laboratory blood test that will increase the ability of doctors to predict the risk of coronary heart disease (CHD). The PLAC test is manufactured by diaDexus, Inc. The test works by measuring an enzyme called lipoprotein-associated phospholipase A2. This enzyme is made by a type of white blood cell called a macrophage. Macrophages make more of this enzyme and release it into the blood when a person has CHD. The test provides supportive information when used with clinical evaluation and other tools for patient risk assessment. An elevated PLAC test result with an LDL-cholesterol less than 130 mg/dL gives doctors increased confidence that patients have 2 to 3 times the risk of CHD when compared with patients having lower PLAC test results.

 Medical Device Review Programs

CDRH’s ODE and OIVD are responsible for the program areas through which medical devices are evaluated or cleared for clinical trials and marketing. This section provides summary information about the major programs and includes a brief description of the premarket approval, product development protocol, humanitarian device exemption, investigational device exemption, and premarket notification programs.

Premarket Approval Applications (PMAs)

Under the Federal Food, Drug, and Cosmetic Act (the Act) and the FDA regulations, Code of Federal Regulations, Title 21 (the Regulations), a manufacturer or others must submit a PMA for FDA review and approval before marketing certain new Class III devices. The PMA submitter must provide reasonable assurance that the device is safe and effective for its intended use and that it will be manufactured in accordance with current good manufacturing practices. As part of the review process, FDA may present the PMA to an expert advisory panel for recommendations. After obtaining the panel recommendations, the agency makes a determination to approve the PMA, deny it, or request additional information. When the FDA either approves or denies the PMA, it must publish a notice in the Federal Register to inform the public of the decision and make available a summary of the safety and effectiveness data upon which the decision is based. This publicly available summary does not include proprietary data or confidential information submitted by the applicant.

Product Development Protocols (PDPs)

The 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act allowed for two product pathways for a class III device: the PMA or, with prior FDA permission, the notice of completion of a PDP. The PDP process is based upon early consultation between the sponsor and the FDA leading to a device development and testing plan acceptable to both parties. It minimizes the risk that the sponsor will unknowingly pursue — with the associated waste of capital and other resources — the development of a device that FDA will not approve. The PDP plan incorporates four discrete stages of FDA review during the device design process: a PDP Summary Outline; FDA/Advisory Panel review of the full PDP; consideration and, where appropriate, pre-approval of design modifications and protocol revisions made during execution of the PDP; and action on the sponsors Notice of Completion. FDA review of the PDP summary may take up to 30 days; the review of the full PDP may take up to 120 days; and FDA must declare the PDP “completed” or “not completed” within ninety days of receiving the Notice. If the FDA finds that the Notice — together with other information previously submitted — shows that the requirements of the PDP, including Quality System Regulation Inspection (or GMP inspection in the case of sponsors without an established satisfactory inspection history) has been met, the agency will declare the PDP complete.

Humanitarian Device Exemptions (HDEs)

An HDE application is essentially the same as a PMA in both form and content but is exempt from the effectiveness requirement of a PMA. Even though the HDE is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose, the application must contain sufficient information for FDA to determine, as required by statute, that the device does not pose an unreasonable or significant risk of illness or injury to patients and that the probable benefit to health outweighs the risk of injury or illness from its use. An HDE application must also contain information that will allow FDA to make the other determinations required by the Act. An approved HDE authorizes marketing of the humanitarian use device (HUD).

PMA Supplements

After a PMA is approved, the PMA holder may request FDA approval of changes to be made. For example, it may request changes to the device, its labeling or packaging, or the manufacturing processes used in its production. Unless prior approval is expressly not required by the PMA regulation, changes that affect the safety or effectiveness of the device require FDA premarket approval. FDA’s review of a PMA supplement may be easy or difficult depending on the type of device, the significance of the change, and the complexity of the technology. Some PMA supplements can be as complex as the original application. Although the statutory time frame is 180 days for PMA Supplements, FDA is committed to reviewing these in shorter time frames and has reduced review time frames through the use of the real-time supplement process, 30-day notices, and expedited reviews.

Investigational Device Exemptions (IDEs)

Under the Act and Regulations, an individual, institution or company may sponsor the clinical investigation of a medical device to establish its safety and effectiveness. Before conducting a clinical trial, however, the sponsor must obtain the approval of an institutional review board (IRB) as well as informed consent from the study subjects at the time of their enrollment in the study. If the investigational device study presents a significant risk to the subjects, the sponsor must obtain FDA’s approval of an “investigational device exemption” application (IDE) under 21 CFR 812. The IDE must contain information concerning the study’s investigational plan, report of prior investigations, device manufacture, IRB actions, investigator agreements, subject informed consent form, device labeling, cost of the device, and other matters related to the study. FDA has 30 calendar days from the date of receipt of the application to approve or disapprove an IDE submission.

IDE Amendments

Although not provided for in the IDE regulations, all submissions related to an original IDE that has been submitted, but not approved, are referred to as “IDE amendments”. After an IDE is approved, related submissions are called “supplemental applications” under the regulations. Identification of IDE amendments enables FDA to track each IDE from the time it is originally submitted until the time it is approved.

IDE Supplements

The IDE regulation requires the sponsor of an investigation of a significant risk device to submit a supplemental application for a number of reasons. For example, a sponsor must submit a supplement if there is a change in the investigational plan when such a change may affect the scientific soundness of the study or the rights, safety, or welfare of the subjects. Supplemental applications also are required for the addition of investigational sites. This regulation also requires the submission of various reports, which are logged in as supplements to IDE applications. These include reports on unanticipated adverse effects of the device; recall and device disposition; failure to obtain informed consent; and annual progress reports, final reports, investigator lists, and other reports requested by FDA.

Premarket Notifications (510(k))

At least 90 days before placing a medical device into commercial distribution, a person required to register must submit to FDA, a premarket notification, commonly known as a “510(k).” The exception to this is if the device is exempt from the 510(k) requirements of the Act by statute or regulation. In addition to other information concerning the device, e.g., a description of the device, a 510(k) summary or a 510(k) statement, the 510(k) submitter must include information to substantiate that the device is “substantially equivalent” to a legally marketed device that is not subject to premarket approval. A substantially equivalent device is marketed subject to the same regulatory controls as the device to which it is found to be substantially equivalent. A device may not be marketed pursuant to a 510(k) until the submitter receives written clearance from FDA.

Medical Device Evaluations and Clearances

CDRH reviews five major types of submissions: Premarket Notification (i.e., a 510(k) submission), Premarket Approval Application (PMA), Product Development Protocol (PDP), Humanitarian Device Exemption (HDE) and Investigational Device Exception (IDE). Devices cleared for marketing through the 510(k) process are too numerous to list here but can be found at ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm.
During Fiscal Year 2003, no PDPs were completed, but CDRH approved the following 31 PMAs and 2 HDEs. These are listed on the next page. The PMA Approval website, available at ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm, contains easy-to-understand one-pagers for each PMA approved.

Original PMA/HDE Approvals for Fiscal Year 2003




04-Nov-02 P020014 Conceptus, Inc. Essure System (Contraceptive Tubal Occlusion Device)


P020004 W. L. Gore & Associates, Inc. EXCLUDER™ Bifurcated Endoprosthesis


P020011 Gen-Probe, Inc. Versant™ HCV RNA Qualitative Assay


P990069 EPMedSystems, Inc. ALERT® System


P020008 Karl Storz Endoscopy-America, Inc. Karl Storz Autofluorescence System
18-Dec-02 P020007 Medtronic, Inc. Medtronic AVE Bridge™ Extra Support Over-the-Wire (OTW) Renal Stent System
23-Dec-02 P010055 Prostalund Operations AB ProstaLund CoreTherm System Microwave Thermotherapy for BPH (Benign Prostatic Hyperplasia)
03-Jan-03 P020028 Phillips Medical Systems, Inc Series 50 XMO Fetal/Maternal Monitor (Model M1350C) with Integrated Fetal Oxygen Monitoring (Fetal Oximeter)
24-Jan-03 P020027 Dade Behring, Inc. Dimension FPSA Flex Reagent Cartridge and Dimension T/F PSA
03-Feb-03 P010001 Ceramtec AG            Ceramic Transcend Hip Articulation System
03-Feb-03 P000013 Howmedica Osteonics Corp. Osteonics ABC System and Trident Ceramic System
14-Mar-03 P010065 E MED Future Needle Zap™
28-Mar-03 P020022 Bayer Corp. Bayer Versant™ HCV RNA 3.0 Assay
28-Mar-03 P020041 FemCap Incorporated FemCap™ Barrier Contraceptive
15-Apr-03 H020007 Medtronic, Inc. Medtronic Activa® Dystonia Therapy
17-Apr-03 P020045 CryoCath Technologies Inc. 7F Freezor® Cardiac Cryoablation Catheter and CCT.2 CryoConsole System
22-Apr-03 P020006 Enteric Medical Technologies, Inc. Enteryx™ Procedure Kit
24-Apr-03 P020026 Cordis Corporation CYPHER™ Sirolimus-eluting Coronary Stent on RAPTOR™ Over- the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System
07-May-03 P020052 St. Jude Medical Response™ CV Catheter System
14-May-03 P020024 AGA Medical Corporation AMPLATZER® Duct Occluder and 180° Delivery System
23-May-03 P020018 Cook Incorporated Zenith® AAA Endovascular Graft and H&L-B One-Shot Introduction System
06-Jun-03 P020002 Cytyc Corp. ThinPrep™ Imaging System
11-Jun-03 P020037 Guidant Corp. FX miniRAIL™ RX Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
07-Jul-03 P030027 Wright Medical Technology, Inc. Ceramic Transcend Hip Articulation
07-Jul-03 H020004 Smith and Nephew Wound Management Dermagraft®
16-Jul-03 P020047 Guidant Corporation MULTI-LINK RX and OTW VISION™ Coronary Stent Systems
29-Jul-03 P020049 Hancock Jaffe Laboratories, Inc. ProCol® Vascular Bioprosthesis
01-Aug-03 P020021 AXCAN Scandipharm, Inc. Wizard X-Cell Photodynamic Therapy Balloon with Fiber Optic Diffuser
12-Aug-03 P020036 Cordis Corporation S.M.A.R.T.TM and S.M.A.R.T.TM ControlTM Nitinol Stent System
13-Aug-03 P020033 Independence Technology, L.L.C. INDEPENDENCE™ iBOT™ 3000 Mobility System
25-Aug-03 P020025 Boston Scientific EP Technologies EPT-1000 XPä RF Ablation System
23-Sep-03 P020031 Microsulis Medical, Ltd. Microwave Endometrial Ablation System (Thermal Endometrial Ablation Device)


P020035 X-Site Medical, L.L.C. X-PRESS™ 6 French Vascular Closure System

The following devices were approved via PMAs, PMA Supplements, and HDEs or cleared via 510(k)s or classified via the Automatic Evaluation of Class III Designation process during FY 03. They represent significant medical breakthroughs because they are first-of-a-kind, e.g., they use a new technology or energy source, or they provide a major diagnostic or therapeutic advancement, such as reducing hospital stays, replacing the need for surgical intervention, reducing the time needed for a diagnostic determination, etc. The information for each device includes the trade name and/or classification name, firm, and date of approval or clearance.

PMA/HDE Approved Devices

  • NeedleZap™ by E MED Future (March 14, 2003)
  • Thoratec HeartMate® SNAP-VE LVAS (Sutures Not Applied-Vented Electric Left Ventricular Assist System) by Thoratec Corporation (November 6, 2002)
  • CYPHER™ Sirolimus-eluting Coronary Stent on RAPTOR™ Over-the-Wire Delivery System; CYPHER™ Sirolimus-eluting Coronary Stent on RAPTORRAIL® Rapid Exchange Delivery System by Cordis Corporation (April 24, 2003)
  • Ceramic Transcend Hip Articulation System by Ceramtec AG (February 3, 2003
  • Osteonics ABC System and Trident Ceramic System by Howmedica Osteonics Corp. (February 3, 2003)
  • Medtronic Activa® Deep Brain Stimulation (DBS) System by Medtronic, Inc. (April 15, 2003)
  • INDEPENDENCE™ iBOT™ 3000 Mobility System by Independence Technology, L.L.C. (August 13, 2003)
  • LADARVision® 4000 Excimer Laser System by Alcon Laboratories, Inc. (October 18, 2002)
  • STAR S4 ActiveTrak™ Excimer Laser System and WaveScan WaveFront® System by VISX, Inc. (May 23, 2003)
  • The Essure™ System by Conceptus, Inc. (November 4, 2002)
  • ThinPrep™ Imaging System by Cytye Corporation (June 6, 2003)

510(k) Clearances or Automatic Evaluations of Class III Designation Devices

  • Reactive Skin Decontamination Lotion (RSDL) by O’Dell Engineering Ltd./E-Z-EM Canada Inc. (March 25, 2003)
  • Repiphysis Limb Salvage System by Wright Medical Technology, Inc. (December 4, 2002)
  • TenoFix Tendon Repair System by Ortheon Medical Llc. (January 22, 2003)
  • TGDc-01 “PRA” Tonometer by Truvision Instruments (October 11, 2002)
  • MP-1 Micro Perimeter by Nidek Technologies (December 23, 2002)
  • Embosphere Microspheres and Embogold Micropheres by Biosphere Medical, Inc. (November 22, 2002)
  • Contour Emboli Pva and Fastracker-325 Infusion Catheter by Boston Scientific Corp. (September 23, 2003)
  • Group B Streptococcus Detection Assay by Infectio Diagnostic, Inc. (November 18, 2002)
  • QCS Her/2 Immunocontrols by OC Sciences (June 18, 2003)

Electronic Submissions

In FY 03, CDRH received 97 complete electronic copies of submissions for PMAs, IDEs, and 510(k)s from 25 different sponsors in addition to the paper submission. These numbers show an increase from FY 02 when 73 complete submissions were received from 14 different sponsors. Prior contact with CDRH’s ODE or OIVD divisions is still requested before developing and sending an electronic copy. Electronic copies enhance the efficiency of the review process, especially when several CDRH offices are involved in the review of the submission. Instructions for submitting submissions in electronic form can be found on the CDRH home page at the address HowtoMarketYourDevice/PremarketSubmissions/ucm134508.htm.

Patient Labeling

Improved patient labeling on medical devices allows the patient or caregiver to better understand both instructions for use and risk-benefit information. OHIP reviews patient labeling for all new Premarket Approval (PMA) submissions and also for 510(k) and HDE submissions when CDRH’s Office of Device Evaluation (ODE) thinks that the patient labeling for a device is particularly important.

 Medical Device Review Performance Statistics

CDRH is responsible for protecting the rights, safety and welfare of patients participating in clinical studies of significant risk medical device research and for evaluating the safety and effectiveness of medical devices before these devices enter the U.S. marketplace.
Following are the details of the review activities and performance for FY 03. Next, the Premarket Approval Applications (PMAs) are reviewed in terms of review time as well as volume. This same analysis is done for PMA supplements. The remainder of this section deals with Humanitarian Device Exemptions (HDEs), Investigational Device Exemptions (IDEs), and Premarket Notifications (510(k)s).


During FY 03, CDRH received 9,872 major submissions compared to 10,323 major submissions in FY 02. [See Table 1 for a breakdown of major submissions received.]

Table 1. Major Submissions Received
FY 02 – FY 03

Original PMAs 49 54
PMA Supplements 645 669
Original IDEs 312 242
IDE Amendments 252 216
IDE Supplements 4,724 4,415
510(k)s 4,320 4,247
Original HDE 5 10
HDE Supplements 16 29
Total 10,323 9,872

On the decision side, CDRH completed the processing of 9,570 major submissions, compared to 10,238 major submissions in FY 02. [See Table 2 for major submissions completed.]

Table 2. Major Submissions Completed
FY 02 - FY 03


Original PMAs 41 31
PMA Supplements 533 494
Original IDEs 307 246
IDE Amendments 251 217
IDE Supplements 4,711 4,424
510(k)s 4,376 4,132
Original HDE 6 2
HDE Supplements 13 24
Total 10,238 9,570

Premarket Approval Applications (PMAs)

CDRH received 54 original PMAs (5 more than the number received in FY 02). The total number of PMAs in inventory (active and on hold) at the end of this fiscal year increased from 73 in FY 02 to 83. The number of active PMAs under review decreased at the end of FY 03 to 35 compared to 42 last year, and those on hold increased from 31 in FY 02 to 48 in FY 03. The total number of PMA actions decreased from 237 to 198 actions. These actions included 54 filing decisions, 87 scientific review decisions, and 57 approval/approvable/not approvable decisions. The 57 original PMA decisions comprised 31 approved PMAs, 16 approvable PMAs, and 10 not approvable PMAs. Of the 31 approvals, 5 were expedited PMAs. See Part 2 (INDUSTRY INFORMATION) for a complete list of PMA approvals. Average FDA review time for original PMAs reaching approval decreased from 161 days in FY 02 to 151 days in FY 03. The non-FDA component of review time increased from 52 days in FY 02 to 70 days this fiscal year. Thus, the total average review time increased to 221 days from 213 days.

Figure 1. Average Review Time for PMA Decision Cohort Approvals

Chart: see text above for data.

Of greater significance to industry is the total elapsed time from submission to decision. In FY 03, the total average elapsed time for PMA decision cohort performance decreased to 359 days from 364 days in FY 02

Figure 2. Original Receipt Cohort PMAs Received and Filed

See data in text above

*First six months

Figure 3. Receipt Cohort PMA Average Elapsed
Time from Filing to Final Action

See text above for data

*First six months

For the first 6 months of FY 03 for PMA receipt cohort performance, the average FDA days from filing to first action increased from 136 in FY 02 to 144 days. The average FDA (total) elapsed time to an approval or to a denial decreased from 235(313) in FY 02 to 193(215) days in FY 03 (see Figure 3). The median FDA (total) elapsed time to an approval or denial decision decreased from 198(300) in FY 02 to 174(218) days in FY 03. All of the statistics of the PMA receipt cohort for FY 03 indicated that CDRH is making decisions faster.
The number of PMA supplements received increased from FY 02’s 645 to 669 in FY 03. There were 739 PMA supplement actions which are down from last year’s 816 total actions. These actions included 6 panel track PMA supplement filing decisions, 98 scientific review decisions, and 635 approval decisions (see Figure 4).

Figure 4. Annual Receipts and Actions for PMA Supplement Decision Cohort

See text above for data

For PMA supplements reaching final action, the average total review time decreased from 105 days in FY 02 to 93 days in FY 03 (see Figure 5), and the average total elapsed time decreased from 124 days to 111 days.

Figure 5. Average Review Time for PMA Supplement Decision Cohort
Final Actions

See text above for data

There were 4 PMA supplements active and overdue at the end of this fiscal year. The number of active supplements decreased to 123 in FY 03 from 127 in FY 02, and the number of supplements on hold increased from 97 to 111. CDRH received 24 more PMA supplements and are reaching final decisions on fewer, but CDRH is taking an average of 13 less days for the decisions. For the first 6 months of FY 03 for PMA supplements receipt cohort performance, the first action and final action are as follows. The average FDA days from filing to first action decreased from 71 in FY 02 to 61 days in FY 03. The average FDA (total) elapsed time to an approval or denial decreased from 74(89) in FY 02 to 57(67) in FY 03. The median FDA (total) elapsed time to an approval or denial decreased from 35(43) in FY 02 to 30(36) days in FY 03.

Real-Time Review of PMA Supplements

A total of 193 requests were received and processed for real-time PMA supplements in FY 03 which represents 29% of all supplements received. Of those submissions, 164 were approved. Most applicants chose telephone conferencing versus a face-to-face meeting or a videoconference. Overall, average review time from receipt to final approval was 44 days.

Product Development Protocols (PDPs)

No original PDPs were approved in FY 03. Three routine PDP supplements and four “Real-Time” PDP Supplements were “approved.” Note that a PDP that has been “declared complete” is considered to have an approved PMA. CDRH continues to encourage the use of the PDP process and will work with interested applicants to fully evaluate their PMA options.

Modular PMA Review

For FY 03 CDRH received a total of 30 PMA shells and 73 modules. A total of 17 modules were found to be acceptable while 5 received deficiency letters. Seventeen modules were rolled into PMA review during FY 03 because they were under review or on hold at the time the PMA was received. Applicants with modular submissions that were under review or deficient when the PMA was received continued to receive feedback under the PMA for those modules. However, this is based on a small number of submissions achieving PMA approval since modular review was implemented. A tracking system with modular PMA query capability became available during FY 99.

Humanitarian Device Exemption (HDE) Applications

CDRH received 10 original HDEs, an increase from 5 received in FY 02. The total number of original HDE actions increased from 23 in FY 02 to 26 in FY 03. These actions included 13 filing decisions, 9 review determinations, 2 approval decisions and 2 other final decisions. A total of 3 first actions were made this fiscal year, a decrease from 6 made last year. The average time from filing to first action decreased from 53 days in FY 02 to 48 days in FY 03. Sixty-seven percent of the first actions made in FY 03 occurred within 75 days. In FY 03, the average elapsed time (from filing to final approval) for original HDEs was 248 days, a decrease from 302 days in FY 02. The average FDA time was 152 days, a decrease from 175 days in FY 02. The average non-FDA time was 96 days, a decrease from 127 days last year. The total number of original HDEs in inventory (active and on hold) at the end of this fiscal year was 10. Of these, 4 were under review and 6 were on hold. There were no active HDEs that were overdue at the end of the fiscal year.

The number of HDE supplements received increased to 29 in FY 03 from 16 in FY 02. There were 37 HDE supplement actions in FY 03, up from 27 in FY 02. These actions included 24 approval, 5 approvable, and 6 not approvable decisions. A total of 29 first actions for HDE supplements were made this fiscal year, an increase from 17 last year. The average time from filing to first action decreased from 53 days in FY 02 to 37 days in FY 03. Ninety percent of the first actions were made within 75 days. The average elapsed time (from filing to final approval) for HDE supplements increased from 74 days in FY 02 to 95 days in FY 03. The average FDA time decreased from 60 days in FY 02 to 43 days in FY 03. Non-FDA time increased from 14 days in FY 02 to 52 days in FY 03. The number of HDE supplements in inventory (active and on hold) at the end of this fiscal year was 11. Of these, 5 were under review and 6 were on hold. There were no active HDE supplements that were overdue at the end of the fiscal year.

Investigational Device Exemptions (IDE)

During FY 03, CDRH reviewed 309 pre-IDEs. Based on these reviews, guidance for the pre-original IDE submissions were provided through meetings with the sponsors, letters, fax, or by phone. CDRH received 242 original IDEs, a decrease from 312 received in FY 02. There were 246 decisions made on original IDEs, a decrease from 307 last year. One hundred percent of all original IDE decisions were issued within 30 days in FY 03. The average review time was 27 days.

Figure 6. Percentage of IDEs Approved on First Review Cycle*

See text above for data

*Based on those IDEs complete enough to permit substantial review.

Of the original IDEs which were complete enough to support substantive review, the percentage of IDEs approved on the first review cycle decreased from 74% in FY 02 to 65% in FY 03 (see Figure 6).

During this fiscal year, 216 IDE amendments were received. Decisions were made on 217 amendments: 73 approvals (34%); 40 disapprovals (18%); and 104 other administrative actions (48%). One hundred percent of these decisions were made within 30 days.
It took an average total time of 180 days to approve IDEs that were initially disapproved, up from 135 days in FY 02. This average approval time consisted of 68 days for FDA time, the same as last year, and 112 days for non-FDA time, up from 67 days in FY 02.

CDRH received 4,415 IDE supplements during FY 03. There were no overdue supplements at the end of the year, and the percentage of supplements reviewed within the 30-day statutory timeframe was 100% in FY 03. The average review time for IDE supplements was 19 days, down from 20 days in FY 02.

Premarket Notification (510(k)s)

CDRH received 4,247 original 510(k)s, as well as 1,856 510(k) supplements (responses to hold letters, the receipt of which restart the 90-day review clock), and 1,690 510(k) amendments (additional information received while the 510(k) is under review, the receipt of which does not affect the review clock). Four 510(k)s were granted expedited status. The total average review time decreased to 96 days in FY 03 from 100 in FY 02, and the average FDA review time was 76 days, down from 79 days in FY 02. The median review time, i.e., the time it took to review 50% of the 510(k)s, has been falling from a high of 164 days in FY 93 to 72 days in FY 03.

Figure 7. Average 510(k) Review Time for Decision Cohort


See text above for data

There were 1,391 510(k)s in inventory (those under active review or on hold) at the end of this fiscal year. The number on hold at the end of FY 03 was 376. Most important, for the eighth consecutive fiscal year there were no 510(k)s active and overdue at the end of the reporting period.
For the first 9 months of FY 03 for receipt cohort performance, the FDA time from receipt to final decision was 68 days.

Figure 8. Receipts and Actions for 510(k) Receipt Cohorts*

See text above for data

*Cut Off Date of 9/30/03 for all receipt cohorts.
**12 month projection based on first 9 months of receipts.

For the first 9 months of FY 03 for receipt cohort performance, the total time from receipt to final decision decreased to 73 days.

Figure 9. FDA Days from Receipt to Final Action for 510(k) Receipt Cohorts*

See text above for data

*Cut Off Date as of 9/30/03 for all receipt cohorts.
**For the first 9 months of FY 03. 90th percentile data not available for FY 03.

Third-Party Review of 510(k)s

During FY 03, CDRH received 190 510(k)s reviewed by third-party organizations under the Accredited Persons provisions (section 523) of the Federal Food, Drug, and Cosmetic Act. This was a 50 percent increase over the 127 submissions received last fiscal year. The increase may be attributable, at least in part, to FDA’s implementation of MDUFMA’s user fee provisions during FY 03 that require applicants to pay a fee when submitting 510(k)s without a third-party review.

CDRH made final decisions on 169 “third-party” 510(k)s in FY 03, an increase from the 132 final decisions in FY 02. The average total elapsed time from a third-party’s receipt of a 510(k) to CDRH’s issuance of a substantial equivalence decision was 74 days, as compared to the average total elapsed time of 112 days for the substantial equivalence decisions on comparable 510(k)s that did not have a third-party review. (This comparison is based on “traditional” and “abbreviated” 510(k)s; “special” 510(k)s are excluded because they typically are not submitted to third parties.) Thus, 510(k)s with a third-party review received marketing clearance 34 percent faster, on average, than comparable 510(k)s reviewed entirely by FDA.

Information on the 510(k) Accredited Persons Program is available on the Center’s Third-party webpage at HowtoMarketYourDevice/PremarketSubmissions/ThirdParyReview/default.htm.

Special 510(k)s

From October 1, 2002 to September 30, 2003 CDRH received 864 Special 510(k)s out of the 4,247 total number of 510(k)s received. Of these 831 have received final decisions (792 were found substantially equivalent, 7 were found not substantially equivalent, and the remaining 32 had other decisions such as withdrawn or deleted) with the average FDA review time of 28 days and the average total time of 34 days.

Abbreviated 510(k)s

During this fiscal year, CDRH received 206 Abbreviated 510(k)s out of the 4,247 total number of 510(k)s received. Two hundred twelve received final decisions (165 substantially equivalent, 3 not substantially equivalent, and 44 other decisions) with a FDA average review time of 96 days and total time of 119 days.

 Greater Efficiency and Effectiveness

CDRH continued efforts to increase efficiency of premarket reviews and to focus review resources on devices that present the most risk. Examples of actions taken during FY 03 are listed in this section.

Proposed Classification Actions

  • Published a proposed rule in the Federal Register on October 22, 2002 to classify the Human Dura Mater into class II.
  • Published a proposed rule in the Federal Register on March 20, 2003 to classify the Silicone Sheeting into class I exempt from premarket notification.

Final Classification Actions

  • Published a final rule classifying the medical washer and medical washer-disinfector intended for general medical purposes to clean and dry surgical instructions, decontaminate or disinfect anesthesia equipment, hollowware, and other medical devices into class II (special controls). [Effective December 16, 2002]
  • Published a final rule classifying resorbable calcium salt bone void filler device intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure into class II (special controls). [Effective July 2, 2003]

Device Reclassification

Any interested person may submit a petition to the agency for reclassification of a device, e.g., from class III to class II, or class II to class I. Additionally, the agency on its own initiative may follow procedures to reclassify a generic type of device. There are five sections under the Federal Food, Drug, and Cosmetic Act by which CDRH may reclassify a device, section 513(e), 513(f) 514(b), 515(b) and 520(l) depending on the status of the device type, such as new device types found to be not substantially equivalent or transitional devices formerly regulated as drugs. The reclassification petition needs to contain sufficient information to allow FDA to determine that the proposed classification can provide reasonable assurance of safety and effectiveness. Reclassification petitions and their final decisions are put on public display at the Dockets Management Branch.

Proposed Reclassification Actions

  • Published a proposed rule in the Federal Register on December 13, 2002 to reclassify the arrhythmia detector and alarm from class III (premarket approval) to class II (special controls) based on new information regarding the device. FDA is also proposing to revise the identification of the arrhythmia detector and alarm to separate the automated external defibrillator (AED) from the identification of the arrhythmia detector and alarm.

Final Reclassification Actions

  • Published a final rule in the Federal Register on December 19, 2002 to reclassify the Absorbable Polydioxanone Surgical Suture from class III to class II. [Effective July 17, 2002]
  • Published a final rule in the Federal Register on December 31, 2002 reclassifying the cutaneous carbon dioxide (PcCO2) monitor from class II (performance standards) into class II (special controls). FDA also reclassified the cutaneous oxygen (PcO2) monitor for an infant patient who is not under gas anesthesia from class II (performance standards) into class II (special controls) and is reclassifying the cutaneous oxygen (PcO2) monitor for all other uses from class III (premarket approval) into class II (special controls).
  • Published a final rule in the Federal Register on March 24, 2003 to reclassify the Knee Joint Patellofemoral Metal/Polymer Porous-coated Uncemented Prosthesis and the Knee Joint Femoraltibial (Unicompartmental) Metal/Polymer Uncemented Prosthesis from class III to class II. [Effective February 3, 2003]

Automatic Evaluation of Class III Designation

Issued an order on April 30, 2003 classifying NIOX Breath Nitric Test System into class II CFR 862.30

  • Issued an order on June 16, 2003 classifying Endotoxin Activity Assay into class II CFR 866.3210
  • Issued an order on July 8, 2003 classifying West Nile Virus IgM Capture ELISA Assay into class II CFR 866.3940

513(g) Submissions

Under Section 513(g) of the Federal Food, Drug, and Cosmetic Act, a person can request information about the classification of a device and the regulatory requirements applicable to the device. Within sixty days of the receipt of such a request, the Office of Device Evaluation (ODE) or the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) will provide a written response to such request.

During this fiscal year, CDRH received 156 513(g) requests for information. CDRH has responded to 135 of these requests, while reviews of the remaining 21 requests are ongoing.

New Challenges

Significant Jurisdictional Issues

Title 21 of the Code of Federal Regulations Part 3 PRODUCT JURISDICTION describes the procedure the agency uses to assign Center jurisdiction over medical products whose jurisdiction is not clear or is in dispute. Requests for Designations (RFDs) over such products are made in writing to the Office of Combination Products which took this role over from the Office of the Chief Mediator and Ombudsman in mid-FY 03. These formal submissions contain the material describing the requester’s product and/or products; a proposal regarding which Center should be given lead designation over their product, and whose authorities (biological, device or drug) should apply.

In FY 03 CDRH participated in the review of 26 out of 34 RFDs received by the FDA’s Ombudsman’s Office, in addition to completing the reviews of 5 RFDs received in FY 02. Of the 31 RFDs [26 assigned in 2003 and the 5 carry over from 2002] which CDRH completed reviews of in FY 03 by both CDRH:

  • CDRH was assigned the lead center in 14 of those requests
  • CDER was assigned lead center in 8
  • CBER was designated lead in 6 RFDs
  • One was ruled by the Office of Combination Products as not an FDA-regulated product and
  • 2 were not due for completion until FY2004.

Least Burdensome

The two sections of the Food, Drug, and Cosmetic Act commonly referred to as the “least burdensome provisions” were enacted by Congress in 1997 to ensure the timely availability of safe and effective new products that will benefit the public and ensure that the United States continues to lead the world in new product innovation and development. During the last few years, CDRH has been working with stakeholders to develop an interpretation of the least burdensome provisions. In the May 3, 2001 Federal Register, the draft guidance document entitled, “The Least Burdensome Provision of the FDA Modernization Act of 1997: Concept and Principles” was released for comment. While the agency received very few comments on the draft, almost all of them strongly supported the guidance and encouraged full implementation of it as soon as possible. Several comments recommended that FDA develop a training program for its staff as well as ways to assess both the agency’s success in implementing the principles and the stakeholders’ satisfaction with FDA’s incorporation of them into daily activities. The agency agreed with these recommendations and has incorporated them into the final guidance. The final document was released on the Internet on September 30, 2002 and in the October 4, 2002 Federal Register (67 FR62252). The guidance may be found on the Center’s website at

Study Determination Inquiries

Every year, CDRH receives numerous inquiries regarding the need to submit an IDE application for research involving medical devices. These inquiries are received through a variety of means - in meetings, by telephone, e-mail, fax or letter. Such inquiries are initiated by a wide variety of entities, including device manufacturers, clinical investigators, and IRB members. In order to respond to these inquiries, CDRH may refer to the IDE regulation (21 CFR 812), particularly sections 812.1 (Scope), 812.2 (Applicability), and 812.3 (Definitions), and the FDA Information Sheet entitled, “Significant Risk and Nonsignificant Risk Medical Device Studies” (hereafter referred to as SR/NSR guidance).

Often, inquiries received can be easily answered by referring to the sources identified above. Occasionally, inquiries will present new situations not clearly identified in the regulation or the SR/NSR guidance. A few inquiries involve the scope of the IDE regulation and/or jurisdictional issues that may require consultation with the other FDA centers. An IDE Memorandum (#D01-1) dated October 26, 2001 was issued to establish written procedures for handling inquiries regarding the need for an IDE application for research involving medical device.

When responding to these inquiries, there are three possible responses: the research is exempt from the IDE regulation; the abbreviated IDE requirements must be met (nonsignificant risk [NSR] study); or the full requirements of the IDE regulation must be met, that is, an IDE application must be submitted to FDA (significant risk [SR] study). In FY 03 ODE received 49 inquires. Of the 49 inquires, there were 13 SR determinations, 13 NSR determinations, 22 exempt determinations, and 6 inquires still under review.

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