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Fiscal Year 2001

Office of Device Evaluation Annual Report
Fiscal Year 2001

U.S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health

Table of Contents

Preface

Part 1 — Advances in Patient Care

CARDIAC PACING TO TREAT HEART FAILURE

PEDIATRIC EXTERNAL DEFIBRILLATOR

EMBOLIZATION PROTECTION DEVICE

CABLE-FREE ENDOSCOPY

INTRAGASTRIC IMPLANT FOR MORBID OBESITY

GLUCOSE MONITORING WRIST WATCH

MEDICAL DEVICES WITH SHARPS INJURY PREVENTION FEATURES

PERIODONTAL PRODUCT

HEPATITIS TESTS

IMPLANTABLE MIDDLE EAR HEARING DEVICE

IMPLANT TO TREAT GLAUCOMA

WOUND AND BURN DRESSING

SKIN, WOUND AND BURN DRESSING

FDA Consumer Web Sites

Publicly Available Device Databases

Consumer Information

Part 2 — Industry Information

Original PMA/HDE Approvals for Fiscal Year 2001

Significant Medical Device Breakthroughs

Devices Approved via PMA/HDE

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

ODE Guidance Documents

Final Guidance Documents Adopted

Draft Guidance Documents for Comment Purposes Only

Part 3 — Key Performance Indices

Resources

Workload

Table 1. Major Submissions Received

Table 2. Major Submissions Completed

Premarket Approval Applications (PMAs)

Figure 1. Average Review Time for PMA Decision Cohort Approvals

Figure 2. Original Receipt Cohort PMAs Received and Filed

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

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

Figure 5. Average Review Time for PMA Supplements

Real-Time Review of PMA Supplements

Product Development Protocols (PDPs)

Modular PMA Review

Humanitarian Device Exemption (HDE) Applications

Investigational Device Exemptions (IDE)

Figure 6. Percentage of IDEs Approved on First Review Cycle

Premarket Notification (510(k)s)

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

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

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

Third-Party Review of 510(k)s

Special 510(k)s

Abbreviated 510(k)s

Significant Medical Device Breakthroughs

Classification Actions

Automatic Evaluation of Class III Designation

Proposed Reclassification Actions

Reclassification Actions

Class II Exemption Petitions

Final 515(b) Calls for PMAs

Part 4 — Major Program Initiatives

Bioterrorism Preparedness

Genetics Testing

Part 5 - Program Support

Guidance for Industry and Reviewers

Least Burdensome

Significant Jurisdictional Issues

CLIA Activities

Advisory Panel Activities

ODE Integrity Program

Freedom of Information Requests

Congressional Inquiries

Publications

ODE Vendor Day

Site Visits

Mentoring Program

Other Employee Programs

Minority Recruitment

Computer Tracking Systems

Office Automation

Electronic Submissions

Video Conferencing

World Wide Web Activity

Device Databases

Consumer Information

Part 6 Operational Summary

Table 3. PMA/HDE/IDE/510(k) Submissions Received

Table 4. Original PMA Decision Cohort Performance

Table 5. Original PMA Receipt Cohort Performance

Table 6. PMA Supplement Decision Cohort Performance

Table 7. PMA Supplement Receipt Cohort Performance

Table 8. PMA Panel Track Supplement Receipt Cohort Performance

Table 9. HDE Submissions Received

Table 10. Original HDE Decision Cohort Performance

Table 11. HDE Supplement Decision Cohort Performance

Table 12. Original IDEs

Table 13. IDE Amendments

Table 14. IDE Supplements

Table 15. 510(k) Decision Cohort Performance

Table 16. 510(k) Receipt Cohort Performance

Appendix A — Summary of Major ODE Programs

Premarket Approval Applications (PMAs)

Product Development Protocols (PDPs)

Humanitarian Device Exemptions (HDEs)

PMA Supplements

Investigational Device Exemptions (IDEs)

IDE Amendments

IDE Supplements

Premarket Notifications (510(k))

Appendix B — ODE Publications

Appendix C — Selected FDA Web Sites

Appendix D — ODE Organization Chart

Appendix E - ODE Staff Roster

Dear Reader: Welcome to our FY 2001 Annual Report. It's a very positive report in many respects. The Office of Device Evaluation approved 53 PMAs last year. This is ten more than we approved in fiscal year 2000 and, in fact, is the largest number approved in any year over the last decade. Our submission review times are respectable. The PMA turnaround time, based on decision cohorts, is somewhat longer than the previous year's results because we cleared the decks of older PMAs that were on our to-do list. The turnaround times for 510(k)s were actually modestly shorter than those for fiscal year 2000. Part 1 of the report - ADVANCES IN PATIENT CARE - consists of a selected group of high profile and clinically significant devices approved or cleared in this fiscal year. Each of the six divisions is well represented. These representative medical devices include products used for improved vision, for assisting patients with congestive heart failure, for ease of diagnosis of gastrointestinal disorders and for improved laboratory testing for hepatitis. We hope to add to this list over the coming years with additional innovative and clinically valuable devices. The remaining parts of the report present key information regarding the numbers and the types of submissions, the review times for each and the comparison with previous years' results. We also list guidances produced and presentations made during the past fiscal year as well as giving a complete roster of ODE staff responsible for the accomplishments during the fiscal year. I am indebted to the superb ODE staff professionals and support staff. They have done all the hard work of carefully assessing the many submissions that we receive. I would like to express my appreciation to the other CDRH Offices that provided support and special expertise in the evaluation of premarketing submissions. I also acknowledge the medical device industry that continues to develop innovative products for patient care. Last, but certainly not least, we dedicate this annual report to the patients that will ultimately benefit from all of these devices. Hopefully we serve your needs efficiently and effectively. We want to do the right thing and we want to do it with dispatch. The ODE managers and I hope you find this report useful, and that you enjoy reading it. Please send any comments to us at odereport@cdrh.fda.gov so that we can improve our annual reports in the years ahead. Now, enjoy the tables, the graphics and the other information found on the following pages. Bernard E. Statland, M.D., Ph.D. Director, Office of Device Evaluation

CARDIAC PACING TO TREAT HEART FAILURE - The InSync® Biventricular Cardiac Pacing System including the InSync® Model 8040 Pulse Generator and leads (Attain™ LV Model 2187 and CS Model 2188), Medtronic, Inc., is used to relieve some of the symptoms associated with moderate to severe heart failure in patients who also have an electrical disturbance in the heart that causes the ventricles not to contract at the same time and are not likely to improve with additional drug therapy. Heart failure is a condition where the heart cannot adequately pump blood around the body and may result in shortness of breath or fatigue during exertion. The InSync system consists of the Model 8040 Pulse Generator (which contains a battery and electronic circuitry) connected to three leads (insulated wires) that deliver electrical impulses to stimulate the heart. One lead is placed in an upper heart chamber (right atrium) and the two other leads are placed one in each of the ventricles. The Attain™ LV Model 2187 and CS Model 2188 are specially designed to be positioned within the heart's venous anatomy via the coronary sinus to achieve left ventricular pacing. The therapeutic effect is achieved by simultaneously stimulating the right and left ventricles. The InSync Pacing System is the first pulse generator approved for the treatment of heart failure.

PEDIATRIC EXTERNAL DEFIBRILLATOR -  The Heartstream FR2 AED with Attenuated Defibrillation Pads, Agilent Technologies, Inc. Heartstream Operation, is the first automatic external defibrillator cleared for use in children less than 8 years of age. It is used in infants and children as a life saving therapy if they suffer sudden death due to ventricular tachycardia or ventricular fibrillation. The Heartstream FR2 AED will be used in the public arena by trained first responder lay people. The device is a system composed of the FR2 pediatric pads and the defibrillator. The FR2 pads use a component (attenuator) in the connector that automatically absorbs energy from the electrical shock coming out of the AED. This results in delivery of a lower-energy shock that is directed at infants and small children. The reduced dose is 50 Joules instead of the standard 150 Joules usually delivered to adults. The availability of this technology may provide earlier recognition and treatment of ventricular fibrillation, which could in turn improve pediatric cardiac arrest survival rates. These patients can now receive a level of care equivalent to that of adults. Agilent Technologies Inc. will be performing an extensive post-market study to evaluate the use of the device.

EMBOLIZATION PROTECTION DEVICE — The PercuSurge Guardwire Plus, PercuSurge, Inc., of Sunnyvale, Calif., a division of Medtronic AVE, is an embolic protection system that is used during interventional cardiology procedures. The device is intended for use on patients who have previously had coronary bypass surgery and whose bypass vein graft has become blocked. These blockages require treatment such as insertion of a stent during angioplasty, which opens up a narrowed vessel. The PercuSurge device consists of a balloon catheter and aspiration catheter. The device is used during these procedures to collect and remove debris created by the interventional treatment thereby preventing blood clots from traveling into the blood stream. The debris--small blood clots, cholesterol crystals, and other particles--may cause serious problems, such as heart attack, if it is swept down the vein graft into the heart.

CABLE-FREE ENDOSCOPY — The Given Diagnostic Imaging System, Given Imaging Ltd., is a wireless, cable-free endoscopic imaging device that obtains video pictures from within the small intestine. The major component of the device is a 2.6cm x 1.1cm disposable capsule which contains a miniature metal oxide semiconductor imager, light emitting diode illuminators, and a transmitter with antenna. The capsule is ingested by a patient, traverses the small intestine with the aid of the natural peristaltic activity of the intestinal muscles, and is excreted intact through the rectum. The patient may continue his or her regular ambulatory activities while the capsule is moving through the body. During its passage through the gastrointestinal tract, the camera acquires and transmits images by way of radiofrequency to receiving antennas, which are attached to the patient's torso. The images are then transferred to a data storage component worn on a belt pack. They are later downloaded and viewed on a computer workstation for interpretation by a physician trained in endoscopy. This device is intended to be used as an adjunctive diagnostic tool in the detection of small bowel mucosal abnormalities.

INTRAGASTRIC IMPLANT FOR MORBID OBESITY — The LAP-BAND Adjustable Gastric Banding System, BioEnterics Corporation, is a surgically implanted device that includes a silicone elastomer band, access port and kink-resistant tubing. The system is intended for the treatment of severe obesity and is used to induce weight loss by limiting food consumption (restrictive rather than malabsorption). The silicone elastomer band is placed around the stomach to create a restricted opening, (stoma), and a small gastric pouch to limit food consumption and induce early satiety (feeling of fullness). The inner surface of the band is inflatable and connected by the kink-resistant tubing to the access port (a remote injection site). The access port allows non-surgical, percutaneous adjustments (through the surface of the skin) to the stoma diameter. Use of the Lap-Band System is an alternative to conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs and to other surgical options (gastric bypass and vertical banded gastroplasty). Use of this device may result in weight loss in severely obese patients.

GLUCOSE MONITORING WRIST WATCH — The GlucoWatch® Automatic Glucose Biographer from Cygnus, Inc., is the first glucose monitoring device that doesn't puncture the skin. Adult diabetics wear the device like a watch where a slight electric current pulls glucose through the skin. Glucose levels are automatically read and recorded every 20 minutes for up to 12 hours. Alarms warn users when high, low, or rapidly declining glucose levels occur. Readings are stored so that users can retrieve them at any time. Patients can better manage their diabetes because they receive information about patterns in their glucose levels. GlucoWatch® results may be similar to finger-stick test results taken at the same time, although some readings will differ significantly from finger-stick tests. GlucoWatch® does not replace finger-stick testing and is not for diabetics below the age of 18.

MEDICAL DEVICES WITH SHARPS INJURY PREVENTION FEATURES — These medical devices are designed with anti-stick characteristics to aid in the prevention of needlestick injuries. They may incorporate components such as retractable, shielded, blunted, or recessed needles. Other safety devices may include needleless systems such as pre-pierced septa and blunt cannulae and valved connectors (reflux valves). Examples of medical devices now available with a sharps injury prevention feature include: IV administration sets and accessories; piston syringes; hypodermic single lumen needles; IV catheters; blood collection devices; needleless access devices/systems; and vial adapters. Desirable characteristics may include: the device is needleless, the safety feature is an integral part of the device, the device preferably works passively, the user can easily tell if the feature is activated, the feature cannot be deactivated and remains protective through disposal, the device performs reliably, is easy to use and practical, and the device is safe and effective for patient care. A number of States recognize the importance of safety device use and have implemented regulations related to the use of these types of devices. During this fiscal year, General Hospital Devices Branch (GHDB) reviewed a total of 34 medical devices with sharps injury prevention features including 22 shielded needles, 8 needleless devices, and 4 retractable devices.

PERIODONTAL PRODUCT — The Emdogain, Biora, Inc., is a reformulation of a previously approved product that allows a change from the two-vial administration system to an easily applied gel-filled syringe application. Emdogain is approved to treat intrabony periodontal defects and as a topical application to exposed root surfaces where there is moderate to severe periodontal disease. Periodontal disease occurs in many adults and many surgical procedures are performed to treat this disease caused by accumulation of bacteria. The periodontal disease process can affect the gums (gingiva) and the bone that supports the teeth. This Biora product attempts to treat the disease process through a biological approach. This product contains amelogenin that is thought to have an important function in the creation of teeth and their support. Emdogain gel is used with periodontal surgery and leaves a resorbable protein matrix on the root surface. The new formulation allows the dentist to apply the gel without mixing and therefore decreases the time the patient must be in the dental chair.

HEPATITIS TESTS — The AMPLICOR™ and COBAS AMPLICOR™ Hepatitis C Virus tests, manufactured by Roche Molecular Systems, Inc., are the first tests approved by FDA for direct detection of hepatitis C virus RNA using nucleic acid amplification. These tests provide highly accurate results for detecting the virus and can establish whether the disease is active and requires treatment.

IMPLANTABLE MIDDLE EAR HEARING DEVICE — The Direct, Soundtec, Inc., is a surgically implanted hearing device intended to help adults with moderate to severe nerve hearing loss. The implanted portion of the device is a tiny magnet that is attached to one of the middle ear bones. It converts sound to mechanical energy that is directly transferred to the middle ear very much the way normal sound does. The brain interprets the vibrations as sound. This device is different from another implantable middle ear hearing device in that it is minimally invasive. The surgeon goes through the ear canal to place the implant in the middle ear. There are no external incisions. This device is an alternative to traditional hearing aids. Adults who choose this device should have already tried traditional hearing aids and not been satisfied with them.

IMPLANT TO TREAT GLAUCOMA — The AquaFlow Collagen Glaucoma Drainage Device, Staar Surgical Company, is used to treat open-angle glaucoma, a condition in which the intraocular pressure is abnormally high. If left untreated, glaucoma can cause blindness. The device is a small cylinder made of collagen. Implanted in the eye, it helps lower the pressure by absorbing excess fluid. The device is designed to maintain a space under the sclera (the white part of the eye). Once placed there, it swells as it absorbs fluid in the eye. This reduces pressure within the eyeball. Later, the device begins to slowly dissolve until it is completely absorbed within 6-9 months. It is the first device that has been approved for use when excess intraocular pressure cannot be completely controlled with medications. Previously cleared glaucoma devices are used only after medications and trabeculectomy surgery has failed. In addition to reducing intraocular pressure, it may allow patients to reduce the number of glaucoma medications they need to control their intraocular pressure.

WOUND AND BURN DRESSING — The OrCel™, Ortec International, is a bilayered cellular matrix in which normal human allogeneic skin cells (epidermal keratinocytes and dermal fibroblasts) are cultured in two separate layers into a Type I bovine collagen sponge and serves as an absorbable biocompatible matrix that provides a favorable environment for host cell migration. When OrCel™ is applied to a wound, it serves as a protective wound dressing and provides a favorable environment for the body's cells to grow and secrete various growth factors at the wound site that in turn aid in wound healing. Under the HDE program, OrCel™ is indicated for use in patients with recessive dystrophic epidermolysis bullosa after surgery to correct the "mitten" hand deformities through hand reconstruction. OrCel™ also received PMA approval for use in closure of split thickness donor site wounds in burn patients. During the autografting procedure, OrCel™ is placed on donor sites to cover the donor site wounds. As healing of donor site wounds in burn patients occurs, it is expected that OrCel™ will dissolve and the patients' own skin cells will replace the OrCel™ cells, creating a new intact skin surface.

SKIN, WOUND AND BURN DRESSING— The DERMAGRAFT®, Advanced Tissue Sciences, is a cryopreserved human fibroblast-derived dermal substitute; it is composed of fibroblasts, extracellular matrix, and a bioabsorbable scaffold. It aides the closure of diabetic ulcers of greater than six weeks duration which extend through the dermis, but without tendon, muscle, joint capsule or bone exposure. DERMAGRAFT® should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot.

This dressing can remain on a shelf up to six months when maintained at a temperature of -75°C ± 10° C. This is a major advantage over similar types of dressings since they usually have a shelf life of approximately five days.

DERMAGRAFT is contraindicated for use in ulcers that have signs of clinical infection or in ulcers with sinus tracts. DERMAGRAFT is contraindicated for use in patients with known hypersensitivity to bovine products, as it may contain trace amounts of bovine proteins from the manufacturing medium and storage solution.

FDA Consumer Web Sites

Publicly Available Device Databases

The Center for Devices and Radiological Health (CDRH) maintains electronic databases of devices previously approved for marketing or declared substantially equivalent to a legally marketed device at http://www.fda.gov/cdrh/mda/mda-databases.html. These databases are available in a searchable format to the public.

Consumer Information

The Division of Small Manufacturers International and Consumer Assistance (DSMICA) also provides information to consumers regarding medical devices and radiation-emitting products to enhance users' ability to avoid risk, achieve maximum benefit, and make informed decisions about the use of such products.

Part 2 — Industry Information

ODE reviews four major types of marketing applications: Premarket Notification (i.e., a 510(k) submission), Premarket Approval Application (PMA), Product Development Protocol (PDP), and Humanitarian Device Exemption (HDE). Devices cleared for marketing through the 510(k) process are too numerous to list here but can be found at http://www.fda.gov/cdrh/510khome.html.

During Fiscal Year 2001, no PDPs were completed, but ODE approved 53 PMAs and 4 HDEs. These are listed below. We recommend turning to the PMA approval website, which is available at http://www.fda.gov/cdrh/mda/index.html, for easy-to-understand one pagers for each PMA approved.

Original PMA/HDE Approvals for Fiscal Year 2001

Significant Medical Device Breakthroughs

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 01. 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.

- Devices Approved via PMA/HDE

Division of Cardiovascular and Respiratory Devices (DCRD)

Novoste™ Beta-Cath™ System by Novoste Corporation (November 3, 2000)

Cordis Checkmate™ System by Cordis Corporation (November 3, 2000)

Heartstream FR2 AED with Attenuated Defibrillation Pads by Agilent Technologies, Inc. (May 2, 2001)

PercuSurge Guardwire Plus by PercuSurge, Inc. a division of Medtronic AVE (June 1, 2001)

Medtronic® InSync® Biventricular Pacing System by Medtronic, Inc. (August 28, 2001)

Model 3100B High Frequency Oscillatory Ventilator by SensorMedics (September 2, 2001)

Division of Clinical Laboratory Devices (DCLD)

GlucoWatch® Automatic Glucose Biographer by Cygnus, Inc. (March 22, 2001)

COBAS Amplicor Hepatitis C Virus (HCV) Test, version 2.0 by Roche Molecular Systems, Inc. (July 3, 2001)

Amplicor Hepatitis C Virus (HCV) Test, version 2.0 by Roche Molecular Systems, Inc. (July 5, 2001)

Vitros Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrators by Ortho-Clinical Diagnostics, Inc. (August 30, 2001)

Division of General, Restorative, and Neurological Devices (DGRND)

OrCel™ Bilayered Cellular Matrix by Ortec International, Inc. (February 21, 2001)

OrCel™ Bilayered Cellular Matrix by Ortec International, Inc. (August 31, 2001)

Dermagraft® by Advanced Tissue Sciences (September 28, 2001)

Division of Ophthalmic and Ear, Nose, and Throat Devices (DOED)

AquaFlow Collagen Glaucoma Drainage Device by STAAR Surgical Company (July 12, 2001)

SOUNDTEC® Direct System by SOUNDTEC, Inc. (September 7, 2001)

Division of Reproductive, Abdominal and Radiological Devices (DRARD)

Lap-Band® Adjustable Gastric Banding System by BioEnterics, Corporation (June 5, 2001)

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

DCLD

INSURE Fecal Occult Blood Test by Enterix, Inc. (January 12, 2001)

N Latex Cystatin C by Dade Behring, Inc. (March 13, 2001)

N-Mid Osteocalcin One Step ELISA Model 30SC4000 by Osteometer Biotech A/S (May 16, 2001)

BreathID system for the detection of Helicobacter pylori by Oridion Medical 1987, LTD. (July 9, 2001)

Lipoprotein Test System by Quantimetrix Corp. (July 25, 2001)

DOED

ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lens by Cantor & Silver Ltd. of England (October 20, 2000)

OptiFree Express Multipurpose Disinfecting Solution by Alcon Universal Ltd. (October 23, 2000)

SeronoCem™ Otologic Bone Cement by Corinthian Medical, LTD (February 12, 2001)

Oto-Cem™ Bone Cement by Ototech, Inc. (September 13, 2001)

DRARD

Given® Diagnostic Imaging System (1^st swallowable capsule containing a tiny video camera that takes pictures of the entire small bowel) by Given Imaging Ltd. (August 1, 2001)

ODE Guidance Documents

ODE issued 40 guidance documents this Fiscal Year, 29 final and 11 draft, which are listed below. These guidance documents and other previously issued guidance documents are available on the World Wide Web (CDRH homepage: http://www.fda.gov/cdrh) which provides easy access to the latest information and operating policies and procedures and from the Division of Small Manufacturers International and Consumer Assistance (DSMICA, HFZ-200). To contact DSMICA, call 800-638-2041 or 301-443-6597; fax 301-443-8818; Email dsmica@cdrh.fda.gov or write to DSMICA (HFZ-200, Food and Drug Administration, 1350 Piccard Drive, Rockville, Maryland 20850-4307.) Many guidance documents are also available through the CDRH Facts-On-Demand (faxback service at 800-899-0381 or 301-837-0111).

- Final Guidance Documents Adopted

ODE

Suggested Format for Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions of FDAMA; Final Guidance for Industry and FDA Staff (November 02, 2000)

Deciding When To Submit a 510(k) for a Change to an Existing Wireless Telemetry Medical Device; Final Guidance for FDA Reviewers and Industry (November 30, 2000)

Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff (February 28, 2001)

Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff (May 29, 2001)

Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers; Final Guidance for Industry (July 12, 2001)

DCRD

Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff (January 31, 2001)

Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adapter 510(k) Submissions (November 1, 2000)

Guidance Document for Vascular Prostheses 510(k) Submissions (November 1, 2000)

Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final

Guidance for Industry and FDA Staff (November 13, 2000)

Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions;

Final Guidance for Industry and FDA (November 29, 2000)

Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final

Guidance for Industry and FDA (November 29, 2000)

Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter; Final Guidance for Industry and FDA Reviewers (November 8, 2000)

DCLD

Guidance for Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells (November 1, 2000)

Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers (November 30, 2000)

Radioallergosorbent Test (RAST) Methods for Allergen-Specific Immunoglobulin E (lgE) 510(k)s; Final Guidance for Industry and FDA (August 22, 2001)

DDIGD

Guidance on Premarket Notifications for Intravascular Administration Sets (October 12, 2000)

Premarket Approval Application (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA (March 2, 2001)

Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA (March 12, 2001)

DGRND

Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semiconstrained Porous-Coated Uncemented Prosthesis (October 31, 2000)

Guidance for Neurological Embolization Devices (November 1, 2000)

Guidance Document for Dura Substitute Devices (November 9, 2000)

Class II Special Controls Guidance: Polymethylmethacrylate (PMMA) Bone Cement 510(k)s (August 2, 2001)

Guidance for Saline, Silicone Gel, and Alternative Breast Implants (August 13, 2001)

DOED

Information for Keratome Manufacturers regarding LASIK; Final Guidance for Industry (June 21, 2001)

DRARD

Guidance for Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport, and Storage of Organs for Transplantation; Final Guidance for Industry and FDA Reviewers (January 16, 2001)

Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA (February 16, 2001)

Class II Special Controls Guidance for Home Uterine Activity Monitors; Final Guidance for Industry and FDA Reviewers (March 9, 2001)

Class II Special Controls Guidance Document: Tissue Culture Media for Human ex vivo Tissue and Cell Culture Processing Applications; Final Guidance for Industry and FDA Reviewers (May 16, 2001)

Bone Sonometer PMA Applications; Final Guidance for Industry and FDA (June 21, 2001)

- Draft Guidance Documents for Comment Purposes Only

Over the Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for Premarket Notifications (November 14, 2000)

Draft Guidance for Prescription Use of Drugs of Abuse Assays Premarket Notifications (November 14, 2000)

Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA (March 1, 20001)

Premarket Approval Applications for In-Vitro Diagnostic Devices Pertaining to Hepatitis C Virus (HCV): Assays Intended for Diagnosis, Prognosis or Monitoring of HCV Infection, Hepatitis C, or Other HCV-Associated Disease; Draft Guidance for Industry and FDA (April 27, 2001)

The Least Burdensome Provisions of the FDA Modernization Act of 1997; Concept and Principles; Draft Guidance for FDA and Industry (May 3, 2001)

Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities (May 21, 2001)

Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff (June 21, 2001)

Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff (July 18, 2001)

A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Draft Guidance for Industry and FDA Staff (July 25, 2001)

Class II Special Controls Guidance Document: Endolymphatic Shunt Tube with Valve; Draft Guidance for Industry and FDA (August 15, 2001)

Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis (September 6, 2001)

Part 3 — Key Performance Indices

ODE 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. market place. Following are the details of ODE's review activities and performance for Fiscal Year 2001 (FY 01). Most of the data discussed below can be found in the tables below and in Part 6 - OPERATIONAL SUMMARY. First, we present the major submissions received and completed. Next, we review the Premarket Approval Applications (PMAs) in terms of review time as well as volume. This same analysis is done for PMA supplements. The remainder of this part deals with Humanitarian Device Exemptions (HDEs), Investigational Device Exemptions (IDEs), and Premarket Notifications (510(k)s).

Resources

ODE ended FY 2001 with 353 employees. During the year, ODE lost 25 full-time employees (18 scientific reviewers, 3 medical officers and 4 clericals) through resignation, reassignment or retirement and added 21 new employees (8 scientific reviewers, 7 medical officers, 1 program analyst and 5 clericals). Through our Intern Program, ODE also had the services of 6 part-time students and professionals.

Workload

During FY 01, ODE received 10,281 major submissions compared to 9,774 major submissions in FY 00. [See Table 1 for a breakdown of major submissions received.]

Table 1. Major Submissions Received
FY 91 — FY 01

On the decision side, ODE completed the processing of 9,954 major submissions, compared to 9,994 major submissions in FY 00. [See Table 2 for major submissions completed.]

Table 2. Major Submissions Completed
FY 91 - FY 01

Premarket Approval Applications (PMAs)

ODE received 70 original PMAs (3 more than the number received in FY 00). The total number of PMAs in inventory (active and on hold) at the end of this fiscal year increased from 76 in FY 00 to 80. The number of active PMAs under review increased at the end of FY 01 to 45 compared to 35 last year, and those on hold decreased from 41 in FY 00 to 35 in FY 01. For the fifth consecutive year, there were no active and overdue PMAs at the end of the fiscal year.

The total number of PMA actions decreased from 321 to 282 actions. These actions included 67 filing decisions, 134 review determinations, and 81 approval/approvable/not approvable decisions.

The 81 original PMA decisions were comprised of 53 approved PMAs, 18 approvable PMAs, and 10 not approvable PMAs. Of the 53 approvals, 11 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 158 days in FY 00 to 129 days in FY 01. The non-FDA component of review time increased from 40 days in FY 00 to 43 days this fiscal year. Thus, the total average review time decreased to 172 days from 198 days.

Figure 1. Average Review Time for PMA Decision Cohort Approvals

Of greater significance to industry is the total elapsed time from submission to decision.In FY 01, the total average elapsed time for PMA decision cohort performance increased from 363 days in FY 00 to 411 days in FY 01. (Please refer to Table 4.)

Figure 2. Original Receipt Cohort PMAs Received and Filed

*First six months

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

*First six months

For the first 6 months of FY 01 for PMA receipt cohort performance, the average FDA days from filing to first action increased from 132 in FY 00 to 133 days.

The average FDA (total) elapsed time to an approval or to a denial decreased from 210(293) in FY 00 to 172(203) days in FY 01 (see Figure 3). The median FDA (total) elapsed time to an approval or denial decision decreased from 180(252) in FY 00 to 177(188) days in FY 01. This means that all of the statistics of the PMA receipt cohort for FY 01 indicate that we are making decisions faster.

The number of PMA supplements received increased from FY 00's 545 to 641in FY 01. There were 695 PMA supplement actions which is down from last year's 747 total actions. These actions included 14 panel track PMA supplement filing decisions, 87 scientific review decisions, and 594 approval decisions (see Figure 4).

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

For PMA supplements reaching final action, the average total review time increased from 94 days in FY 00 to 97 days in FY 01, and the average total elapsed time decreased from 122 days to 110 days (see Figure 5).

Figure 5. Average Review Time for PMA Supplements

Unlike in FY 97, FY 98, FY 99 and FY 00, there were 6 PMA supplements active and overdue at the end of this fiscal year. The number of active supplements increased to 152 in FY 01 from 98 in FY 00, and the number of supplements on hold increased from 84 to 94. We received about 100 more PMA supplements and are reaching final decisions on more, but we are taking an average of 5 fewer days for the decisions.

For the first 6 months of FY 01 for PMA supplements receipt cohort performance, the first action and final action as follows. The average FDA days from filing to first action increased from 63 in FY 00 to 71 days in FY 01. The average FDA (total) elapsed time to an approval or denial remained the same from 65(81) in FY 00 to 65(72) in FY 01. The median FDA (total) elapsed time to an approval or denial increased from 32(40) in FY 00 to 37(43) days in FY 01.

Real-Time Review of PMA Supplements

A total of 162 requests were received and processed for real time PMA supplements in FY 01 which represents 25% of all supplements received. Of those submissions, 131 were approved. Most applicants chose telephone conferencing versus a face-to-face meeting or a videoconference. The majority of these applications were reviewed in DCRD (63%) followed by DGRND (21%), DOED (5%), DRARD (5%), DCLD (4%) and DDIGD (2%). Overall, average review time from receipt to first action (approvable, not approvable or approval order) was 53 days, and was 50 days from receipt to final approval.

Product Development Protocols (PDPs)

No original PDPs nor "Real Time" PDP supplements were approved in FY 01. Seven routine PDP supplements were approved. Note that a PDP that has been declared complete is considered to have an approved PMA. ODE 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 FY01 ODE received a total of 37 PMA shells and 32 modules. A total of 7 modules were found to be acceptable while 8 received deficiency letters. A number of modules were rolled into PMA review during FY 01 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. Review times for PMAs that had modular submissions were slightly lower than for traditional PMAs. 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

ODE received 5 original HDEs, 6 less than the number received in FY 00. The total number of original HDE actions decreased from 36 in FY 00 to 30 in FY 01. These actions included 7 filing decisions, 15 review determinations, 4 approval decisions and 4 other final decision.

A total of 6 first actions were made this fiscal year, a decrease from 8 made last year. The average time from filing to first action decreased from 61 days in FY 00 to 42 days in FY 01.

One hundred percent of the first actions made in FY 01 occurred within 75 days.

The 4 approval decisions were comprised of 4 approved HDEs and no approvable HDEs.

In FY 01, the average elapsed time (from filing to final approval) for original HDEs was 243 days, an increase from 216 days in FY 00. The average FDA time was 143 days, an increase from 112 days in FY 00. The average non-FDA time was 100 days, a decrease from 104 days last year.

The total number of original HDEs in inventory (active and on hold) at the end of this fiscal year was 7. Of these, 1 was 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 from 10 in FY 00 to 16 in FY 01. There were 15 HDE supplement actions in FY 01, up from 11 in FY 00. These actions included 11 approval decisions and 1 not approvable decision.

A total of 12 first actions for HDE supplements were made this fiscal year, an increase from 10 last year. The average time from filing to first action increased from 44 days in FY 00 to 52 days in FY 01. Sixty-seven percent of the first actions were made within 75 days.

The average elapsed time (from filing to final approval) for HDE supplements decreased from 76 days in FY 00 to 46 days in FY 01. The average FDA time increased from 43 days in FY 00 to 46 days in FY 01. Non-FDA time decreased from 33 days in FY 00 to no days in FY 01.

The number of HDE supplements in inventory (active and on hold) at the end of this fiscal year was 5. Of these, 4 were under review and 1 was on hold. There were no active HDE supplements that were overdue at the end of the fiscal year.

Investigational Device Exemptions (IDE)

During FY 01, ODE reviewed 287 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.

ODE received 284 original IDEs, a decrease from 311 received in FY 00. There were 284 decisions made on original IDEs, a decrease from 320 last year. One hundred percent of all original IDE decisions were issued within 30 days in FY 01. The average review time was 28 days.

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

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

Of the IDEs which were complete enough to support substantive review, the percentage of IDEs approved on the first review cycle increased from 76% in FY 00 to 80% in FY 01 (see Figure 6).

During this fiscal year, 206 IDE amendments were received. Decisions were made on 207 amendments: 73 approvals (35%); 39 disapprovals (19%); and 95 other administrative actions (46%). Ninety-nine percent of these decisions were made within 30 days.

It took an average total time of 141 days to approve IDEs that were initially disapproved, up from 136 days in FY 00. This average approval time consisted of 59 days for FDA time, down from 70 days last year, and 82 days for non-FDA time, up from 66 days in FY 00.

ODE received 4,811 IDE supplements during FY 01. 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 percent in FY 01. The average review time for IDE supplements was 21 days, up from 20 days in FY 00.

Premarket Notification (510(k)s)

ODE received 4,248 original 510(k)s, as well as 1,579 510(k) supplements (responses to hold letters, the receipt of which restart the 90-day review clock), and 2,620 510(k) amendments (additional information received while the 510(k) is under review, the receipt of which does not affect the review clock).

The total average review time decreased to 96 days in FY 01 from 102 in FY 00, and the average FDA review time was 75 days, down from 77 days in FY 00. 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 a current low of 72 days in FY 00 and FY 01.

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

There were 1,316 510(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 01 was 382. Most important, for the sixth 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 01 for receipt cohort performance, the FDA time from receipt to final decision was 65 days.

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

*Cut Off Date of 9/30/01 for all receipt cohorts. **12 month projection based on first 9 months of receipts.

For the first 9 months of FY 00 for receipt cohort performance, the total time from receipt to final decision remained 75 days.

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

*Cut Off Date as of 9/30/01 for all receipt cohorts. **For the first 9 months of FY 01. 90th percentile data not available for FY 01.

Third-Party Review of 510(k)s

During fiscal year (FY) 2001, ODE received 107 510(k)s reviewed by third-party organizations under the Accredited Persons provisions (section 523) of the Federal Food, Drug, and Cosmetic Act. This is a small percentage of all 510(k)s that were eligible for third-party review, but is a 128-percent increase over the 47 such submissions received by ODE last fiscal year. ODE made final decisions on 99 "third party" 510(k)s in FY 2001, an increase from the 46 final decisions in FY 2000. The average total elapsed time from a third party's receipt of a 510(k) to ODE's issuance of a substantial equivalence decision was 65 days, as compared to the average total elapsed time of 91 days for ODE's decisions on comparable 510(k)s that did not have a third-party review.

In the FEDERAL REGISTER of March 8, 2001 (66 FR 13936), the Center announced an expansion pilot that permits third-party review of 510(k) submissions for a greatly expanded list of devices. The pilot allows—subject to certain specified conditions—third-party review of approximately 460 Class II devices for which device-specific guidance does not exist. Previously, device-specific guidance existed for each Class II device that was eligible for third-party review. The expansion more than tripled the number of eligible devices, increasing the total from 211 devices to more than 670. Information on the expansion pilot is available on the Center's third party web page at http://www.fda.gov/cdrh/thirdparty.

Special 510(k)s

From October 1, 2000 to September 30, 2001 ODE received 717 Special 510(k)s out of the 4,248 total number of 510(k)s received, and 685 have received final decisions with the average FDA review time of 28 days and the average total time of 32 days, and 643 were found substantially equivalent, 3 were found not substantially equivalent, and the remaining 39 had other decisions such as withdrawn or deleted.

Abbreviated 510(k)s

During this fiscal year, ODE received 174 Abbreviated 510(k)s out of the 4,248 total number of 510(k)s received. One hundred seventy-four received final decisions (147 substantially equivalent, 1 not substantially equivalent, and 26 other decisions) with a FDA average review time of 82 days and total time of 99 days. None of the Abbreviated 510(k)s went over 90 days.

Significant Medical Device Breakthroughs

During FY 01, ODE approved 16 PMAs and cleared 10 510(k)s that represent significant medical device breakthroughs. See Part 2 - INDUSTRY INFORMATION, Significant Medical Device Breakthroughs - for a complete listing.

Classification Actions

• Published a final rule in the Federal Register on May 16, 2001 classifying Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications into Class II.

• Published a final rule (technical amendment) in the Federal Register on May 22, 2001 classifying Pedicle Screw Spinal Systems into Class II.

Automatic Evaluation of Class III Designation

• Issued an order on November 13, 2000 classifying Triage B-Type Natriuretic Peptide (BNP) Test into Class II.

• Issued an order on December 5, 2000 classifying Dulbecco's Modified Eagle Medium "DMEM" into Class II.

• Issued an order on June 11, 2001 classifying the Given Diagnostic Imaging System into Class II.

Proposed Reclassification Actions

• Published a proposed rule in the Federal Register on May 9, 2001 to reclassify Automated Differential Cell Counters from Class III into Class II.

• Published a proposed rule in the Federal Register on August 15, 2001 to reclassify the Endolymphatic Shunt Tube with Valve from Class III into Class II.

• Published a proposed rule in the Federal Register on September 6, 2001 to reclassify the Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis from Class III into Class II.

Reclassification Actions

• Published a final rule in the Federal Register on October 10, 2000 reclassifying Endosseous Dental Implant Accessories from Class III into Class II.

• Published a final rule in the Federal Register on February 28, 2001 reclassifying the Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis from Class III into Class II.

• Published a final rule in the Federal Register on March 9, 2001 reclassifying the Home Uterine Activity Monitor from Class III into Class II.

• Published a final rule in the Federal Register on April 10, 2001 reclassifying Six Cardiovascular Preamendments Class III Devices into Class II.

• Published a notice in the Federal Register on April 30, 2001 denying the petition to reclassify the Totally Implanted Spinal Cord Stimulator.

• Issued a reclassification order on September 4, 2001 reclassifying the Absorbable Polydioxanone Surgical Suture from Class III into Class II.

Class II Exemption Petitions

• Published a Class II exemption in the Federal Register on October 18, 2000 for Total Triiodorthyronine Test System submitted by Abbott Laboratories.

• Published a Class II exemption in the Federal Register on December 8, 2001 for Catheter, Retention, Barium Enema submitted by E-Z-EM, Inc.

• Published a Class II exemption in the Federal Register on March 21, 2001 for Pharmacy Compounding System submitted by Baxter HealthCare, Corporation.

• Published a Class II exemption in the Federal Register on September 18, 2001 for F Spoon Fluoroscopic Accessory submitted by the F Spoon Company.

Final 515(b) Calls for PMAs

There were no calls for PMAs in FY 01.

Part 4 — Major Program Initiatives

Bioterrorism Preparedness

ODE is currently involved in several resource-intense initiatives related to national bioterrorism preparedness and response. ODE established liaison and collaboration with other government agencies and the military to prepare for regulatory responsibilities applicable to in vitro diagnostic products and other medical devices that are critical to bioterrorism preparedness efforts. ODE is also developing a pool of expert reviewers to meet the expected demands related to timely premarket review and approval of these devices.

Although ODE has been involved in CDRH bioterrorism preparedness activities in the past, during this fiscal year our involvement intensified to the point that it has become a major program initiative. These activities cover several ODE divisions and different aspects of the problem.

The Division of Clinical Laboratory Devices (DCLD) formed the DCLD IVD Chem-Bioterrorism preparedness Working Group to develop a clear interpretation of the IVD regulations for supporting CDC's and the military's bioterrorism preparedness activities. The medical and public health preparedness and response to bioterrorism threats include the identification of threat agents by using in vitro diagnostic devices. Most laboratory reagents and test kits used for the identification of threat agents are not routinely used in the clinical laboratory and have not been cleared or approved by FDA.

DCLD has been interacting with manufacturers involved in the development and data gathering on devices for the identification of bioterrorism threat agents. DCLD has met with several companies to clarify the premarket review requirements and routes available to obtain clearance or approval for medical uses. Our scientists have participated in discussions with industry, the CDC and the military in determining options for making new in vitro diagnostic devices available and in clarifying requirements for testing during the investigational phase of the products.

The Division of Dental, Infection Control, and General Hospital Devices (DDIGD) evaluated a modification of a device intended for use by the military to remove chemical agents from clothing and skin. It also began discussions with another applicant on a device intended for the same use but employing a different formulation. DDIGD evaluated submissions during the fiscal year on liquid chemical agents, ultraviolet light air purifiers, and sterilizers that could be used to decontaminate surfaces and products.

The Division of Cardiovascular and Respiratory Devices (DCRD) has been involved in the Ad Hoc Committee on Device Shortage for Bioterrorism Preparedness and Response. The Committee considered a list of devices that would be needed in the event of a chemical or biological attack.

POS is also involved in bioterrorism preparedness and response by providing support to the ODE Divisions that are directly involved. In particular, the IDE staff has been very helpful by providing guidance on difficult regulatory issues.

Genetics Testing

During FY O1, three agencies within HHS (the FDA, the Centers for Disease Control and Prevention (CDC), and the Center for Medicare and Medicaid Services (CMS)) have been collaborating on the Department's role in th