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U.S. Department of Health and Human Services

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OCD FY2005: Increasing Access to Innovative Technologies

Enabling Technology and Innovation 

The following devices are examples of advanced device technologies that FDA approved or cleared during FY 2005. A comprehensive list of approved medical devices is available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/default.htm.

 Minimally Invasive Surgery
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm080704.htm
The ExAblate 2000 System, manufactured by InSightec, is the first non-invasive surgery device to combine magnetic resonance imaging and focused ultrasound to target and destroy uterine fibroids. The device is intended to treat women who have completed childbearing or do not intend to become pregnant. It is an alternative to myomectomy, hysterectomy, watchful waiting, hormone therapy, or uterine fibroid embolization.

  Oral rinse for gingivitis
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078634.htm
The Decapinol Oral Rinse, manufactured by Sinclair Pharmaceuticals Limited, is a prescription oral rinse. When used, the oral rinse forms a physical barrier to bacterial attachment on tooth surfaces. The interference to bacterial attachment reduces plaque associated with gingivitis.

  Surgical Laser for Assisted Reproduction
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm079510.htm
The Hamilton Thorne Zona Infrared Laser Optical System (ZILOS-tk®),   manufactured by Hamilton Thorne Biosciences, Inc., is a microscope guided laser system used to drill a small hole in the zona pellucida, the hard membrane that surrounds the ovum, and facilitate embryo hatching prior to implantation. The device may increase implantation rates in older women (older than 37 years) and patients utilizing frozen embryos.

  Treating Aneurysms of the Thoracic Aorta
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078658.htm
The GORE TAG Endoprosthesis System, manufactured by W.L. Gore and Associates, Inc., is the first endovascular grafting system approved to treat aneurysms of the descending thoracic aorta (in the chest). The device is intended to prevent aneurysm ruptures by making a new path for blood flow. The GORE TAG Endoprosthesis can be used instead of more invasive open surgery to repair the aorta, the main artery that carries blood in the body.

  Dura Mater Sealant for Neurosurgery
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078645.htm
The DuraSeal Dural Sealant System, manufactured by Confluent Surgical, Inc., is the first material approved for sealing leaks in the dura mater covering of the brain during neurosurgical procedures. The sealant is intended to aid in preventing cerebrospinal fluid leakage through suture wound edges of the dura mater is absorbable and will biodegrade within 4-8 weeks after application.

  Drug-Eluting Pacemarker Lead Releasing Steroid to Improve Healing
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078503.htm
The SelectSecure™ Lead Model 3830, manufactured by Medtronic, Inc., is a surgically implanted wire that connects the heart to an implanted pacemaker. A steroid, beclomethasone dipropionate, is released into the body from the tip of the lead to improve healing after implantation. The lead, in conjunction with an implanted pacemaker, treats irregular or slow heart rhythm or bradycardia. If bradycardia is not treated, it can lead to fatigue, shortness of breath, dizziness, or fainting.

New Prosthetic Jaw Joint
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078449.htm
The Total Temporomandibular Joint Replacement System, manufactured by Walter Lorenz Surgical, Inc., is a prosthetic jaw joint intended for patients who need a total jaw replacement due to severe arthritic conditions, fused joints, previous multiple surgeries, severe fractures, tumors, or severely degenerated joints. The device may reduce jaw pain, reduce interference with eating and increase the ability to open the mouth.

  First DNA-Based Test For a Drug Metabolizing Enzyme
http://www.accessdata.fda.gov/cdrh_docs/pdf5/K051824.pdf
The Invader ® UGT1A1 Molecular Assay, manufactured by Third Wave Technologies, Inc., is intended to help doctors make personalized drug treatment decisions. This assay enables doctors to use a patient’s genetic information for determining whether to modify the dose for drugs that are broken down in the body by UGT enzymes. Drug dose modification could minimize harmful drug reactions and prevent patients from being improperly treated with suboptimal doses. The Invader assay joined a growing list of DNA-based tests used for individualized medical care.

New Technology For Maintaining Patient Data
http://www.accessdata.fda.gov/cdrh_docs/pdf3/k033440.pdf
The VeriChip Implantable Radiofrequency Transponder System, manufactured by Applied Digital Solutions, consists of an implantable chip, an introducer, and a reader. After the chip is implanted under the skin, a caregiver is able to retrieve a unique patient identifier and patient medical information from a prescription web site when the patient is otherwise unable to provide this information. The medical information on the web site is supplied by the patient and can only be accessed with appropriate authorization.

  The First Surgical Marker With RFID Technology
http://www.accessdata.fda.gov/cdrh_docs/pdf4/k042555.pdf
The SurgiChip Tag Surgical Marker system, manufactured by SurgiChip Inc., is the first surgical marker to use radio frequency identification (RFID) technology to mark an anatomical site for surgery. This external surgical marker tag is intended to lessen the likelihood of wrong-site, wrong-procedure and wrong-patient surgeries.

  Prevention of Future Strokes
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078471.htm
The Xact® Carotid Stent System, manufactured by Abbott Vascular Devices, is used to open blood vessels in patients who have had a stroke, who have a very tight blockage in the vessels of the neck, and who have counter indications for the surgical alternative. The device, a mesh stent with delivery catheter (Xact® Carotid Stent System), is used in combination with a micromesh filter basket on a catheter to trap loose debris particles (Emboshield Embolic Protection System).

  Artificial Intervertebral Disc
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm080693.htm
The CHARITE™ Artificial Disc, manufactured by DePuy Spine, Inc, is indicated for use in spinal reconstruction in patients with degenerative disc disease. The device consists of an artificial intervertebral disc of metal and plastic that is surgically implanted to replace a diseased or damaged intervertebral disc. The artificial disc may restore disc height, reduce pain, and allow movement at the level where it is implanted.

Providing Circulatory Support for Hospitalized Patients Awaiting Heart Transplantation
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm080816.htm
The Syncardia Temporary CardioWest Total Artificial Heart (TAH-t), manufactured by SynCardia Systems, Inc., is indicated for use in heart transplant-eligible candidates at risk of imminent death from biventricular heart failure. The artificial heart provides circulatory support for the hospitalized patients who are awaiting heart transplantation. The device also improves kidney and liver functions because normal blood flow is restored—making the patient a better candidate for heart transplantation.

Temporarily Improving Insufficient Blood Flow to the Brain
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078652.htm
The NeuroFlo™ Catheter, manufactured by CoAxia, Inc., is used to treat cerebral ischemia, insufficient blood flow to the brain, resulting from symptomatic vasospasm. Symptomatic vasospasm, the squeezing down of a blood vessel in the brain, results in symptoms similar to stroke such as difficulty in speaking, movement, or understanding. The NeuroFlo Catheter is intended to increase blood flow to the upper body and brain by temporarily reducing blood flow to the lower part of the body.

 MDUFMA

FDA worked to implement the Medical Device User Fee and Modernization Act (MDUFMA) of 2002. MDUFMA allows CDRH to collect user fees from companies that submit medical device applications. CDRH has used the additional funds to hire additional staff expertise and develop better systems to support more effective and timely review.

MDUFMA requires CDRH to pursue a complex and comprehensive set of review goals that are more aggressive each successive year. CDRH reports on performance relative to the specified goals at the end of each year. In FY 2005 CDRH fulfilled MDUFMA statutory requirements and maintained device review performance in areas not covered by official performance goals. Enactment of the Medical Device User Fee Stabilization Act of 2005 provided the final action necessary to satisfy the Committee’s request for “updates on the progress of the MDUFMA legislative change.” The Stabilization Act enabled the legislative changes required to continue the medical device user fee law through FY 2007. Information about MDUFMA is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm.

Documents, Notices, and Reports Related to MDUFMA
In FY 2005 CDRH published three Federal Register notices about MDUFMA implementation. In addition, for FY 2005, CDRH prepared three reports to Congress related to MDUFMA:

  • Annual Report to Congress on the Office of Combination Products for FY 2005
  • Annual Financial Report to Congress –for FY 2005
  • Annual Performance Report to Congress –for FY 2005

  Third Party Inspection Program
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ PostmarketRequirements/ThirdPartyInspection/ucm125410.htm
CDRH continued implementation of the MDUFMA Accredited Persons (APs - Third Party inspection) program designed to reduce regulatory burden on providers, patients, and consumers of health and human services by increasing efficiency and modernizing regulatory oversight. During FY 2005 the number of qualifying inspections for APs increased by 10 percent. Currently, 5 of 16 APs are eligible to conduct independent inspections for the FDA.In a letter to 8,600 domestic Class II and Class III device establishments, CDRH announced the publication of the AP Eligibility Guidance and outlined the benefits to manufacturers who use an AP to conduct their AP inspections.

  MDUFMA Stakeholders Annual Meeting
http://www.fda.gov/cdrh/meetings/111804.html
CDRH held the 2 nd Annual Stakeholder Meeting on the Implementation of MDUFMA on November 18, 2004. This meeting addressed FDA's progress in implementing the various MDUFMA provisions, including the guidance documents FDA issued under the new law. The meeting gave stakeholders an opportunity to provide information and share their views on the implementation of MDUFMA.

  Small Business Determinations (SBD)
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109195.htm
Firms that qualify as MDUFMA small businesses are eligible to pay reduced fees for medical device applications that are subject to a user fee. In FY 2005 CDRH received, evaluated, and responded to 674 requests for Small Business Determinations under the meaning of MDUFMA, and granted 644, an increase of 13 percent over FY 2004.

  MDUFMA Performance
CDRH made steady progress in developing and deploying process improvements in its medical device review program. The Center set milestones for measuring review progress more frequently and for tracking each PMA individually. Quarterly progress updates are available on the MDUFMA web site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm.

  Training and Professional Development
CDRH is committed to strengthening its workforce. CDRH’s Staff College provides employees with comprehensive professional and technical training through classroom training, live satellite teleconferences, web casts, online coursework, and a variety of seminars and lectures. In FY 2005 CDRH increased to 37 the number of technical science courses available to staff andimproved its new employee training and reviewer training. In total, 852 employees enrolled in 153 different courses. The Center also made significant advances toward developing science, management and business competency models.

  Training and Professional Development
CDRH is committed to strengthening its workforce. CDRH’s Staff College provides employees with comprehensive professional and technical training through classroom training, live satellite teleconferences, web casts, online coursework, and a variety of seminars and lectures. In FY 2005 CDRH increased to 37 the number of technical science courses available to staff andimproved its new employee training and reviewer training. In total, 852 employees enrolled in 153 different courses. The Center also made significant advances toward developing science, management and business competency models.

  Guidance Development
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109195.htm
Guidance development facilitates interactions with industry and ensures effective program implementation. CDRH issued guidance documents on premarket approval applications, premarket assessment of pediatric medical devices, and premarket assessment and use of validation data for reprocessed single use devices. In total, CDRH issued 28 guidance documents in FY 2005.

Utilizing External Expertise

  CDRH Advisory Committees
http://www.fda.gov/AdvisoryCommittees/ CommitteesMeetingMaterials/MedicalDevices/default.htm
CDRH held 17 Federal Advisory Committee panel meetings in 2005. These panels of external experts reviewed and made recommendations to FDA on 10 premarket approval (PMA) applications, one humanitarian device exemption (HDE), two premarket notifications (510(k)s), five preamendment device classifications, and six general issues. Among the topics addressed at the meetings were issues associated with significant breakthrough technologies for endovascular aortic repair, blood vessels connection, and hip joint resurfacing.

  Medical Device Fellowship Program (MDFP)
http://www.fda.gov/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/ MedicalDeviceFellowshipProgramCDRH/default.htm
CDRH established the Medical Device Fellowship Program (MDFP) 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. In FY 2005 MDFP worked with National Research Council Associates Program on a Resident Research Associateship Program, and on a memorandum of understanding (MOU) with Duke University and Brigham and Women’s Hospital. MDFP programs provide doctoral scientists and engineers of unusual ability and promise or proven achievement with an opportunity to conduct research on problems which are compatible with CDRH research and review interest.

By the end of FY 2005 CDRH had brought in 74 new experts under the Medical Device Fellowship Program (MDFP). These included engineers, medical officers, statisticians, scientists, project managers, consumer safety officers, and program support staff to increase CDRH’s scientific and technical capabilities.

  Third Party Review Program
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ HowtoMarketYourDevice/PremarketSubmissions/ThirdParyReview/default.htm
The Accredited Persons Program was created by the FDA Modernization Act of 1997 (FDAMA), based on an FDA pilot. The purpose of the program is to improve the efficiency and timeliness of FDA's 510(k) process, the process by which most medical devices receive marketing clearance in the United States. Under the program, FDA has accredited third parties (Accredited Persons) that are authorized to conduct the primary review of 510(k)s for eligible devices. Persons who are required to submit 510(k)s for these devices may elect to contract with an Accredited Person and submit a 510(k) directly to the Accredited Person. The Accredited Person conducts the primary review of the 510(k), then forwards its review, recommendation, and the 510(k) to FDA. By law, FDA must issue a final determination within 30 days after receiving the recommendation of an Accredited Person. Submitters of 510(k)s who do not wish to use an Accredited Person may submit their 510(k)s directly to FDA.

In FY 2005FDA increased the use of the Third Party Review Program for 510(k) submissions. CDRH received 243 510(k) submissions, which were reviewed by third party organizations under the Accredited Persons provisions (section 523) of the Federal Food, Drug, and Cosmetic Act. The program realized a 27 percent increase since FY 2003. The Center made final decisions on 251 third party 510(k) submissions, an increase from the 244 final decisions in FY 2004. CDRH continued to improve the quality and consistency of third party reviews and facilitate timely action on these submissions. In FY 2005 CDRH conducted a training session for FDA staff and for third party reviewers. In addition, telephone conferences with all third parties in January and April 2005 provided a routine forum for discussing issues and answering questions.

  Maintaining the Quality of Premarket reviews

  CDRH quality review program
CDRH’s quality review program for premarket submissions evaluates the quality of its scientific review. The program started by focusing on three key areas:

  • biocompatibility
  • sterilization
  • statistical analysis.

The Center has initiated improvements in reviewer training in these areas, based on the findings of this program. Other review areas will soon be added to the program, including software and clinical protocol reviews. This on-going process will allow CDRH to improve the quality of its reviews in key scientific areas, thus ensuring that reviewers consistently ask the right questions at the right times.