Tobacco Documents Online

~ ~Stavicr1 `', t '~ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service / c STATEMENT BY DAVID A. KESSLER, M.D. COMMISSIONER OF FOOD AND DRUGS "I BEFORE THE COMMITTEE ON ENERGY AND COMMERCE • Food and Drug Administration Rockville MD 20857 , SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT U.S. HOUSE OF REPRESENTATIVES JULY 14, 1994 ~ TO BE RELEASED ONLY UPON DELIVERY ~ C~J ~ z"D 00

• • • Mr. Chairman, my name is David Kessler, Commissioner of Food and Drugs. I am pleased to testify on H.R. 4728, the Medical Device Fee Act of 1994. This legislation builds on the successful cooperative effort that led to the historic enactment cpf the Prescription Drug User Fee Act of 1992 (PDUFA). User THE MEDICAL DEVICE APPROVAL PROCESS Before discussing the bill, I would like to provide the Committee a brief overview of the medical device approval process and where stand today. This should help set the stage for our discussion user fee funding for this rather complex regulatory program. we of Medical devices include several thousand health products, from simple articles such as thermometers, tongue depressors, and heating pads, to sensitive and complex devices such as pacemakers, intrauterine devices, and kidney dialysis machines. Prior to 1976, no specific Federal statutory program existed to regulate medical devices. The increasing sophistication and complexity of medical devices coupled with a growing number of safety concerns helped forge a consensus that these products should be regulated by the Federal Government. This led to enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and, Cosmetic Act to give the Food and Drug Administration (FDA) specific authority to regulate the safety and effectiveness of medical devices. o ~ 1 ~ C.~.~ ~ . CD ZZ rD

The 1976 law provided several mechanisms to achieve this goal, including classification of medical devices, device listing, establishment registration, adherence to Good Manufacturing Practices (GMPs), and extensive control over market introduction.of medical devices. The Safe Medical Devices Act of 1990 (SMDA) abd the Medical Device Amendments of 1992 revised and expanded the 1976 Act. Thus, any person engaged in the manufacture, preparation, propagation, compounding, assembly, or-processing of a medical device intended for human use is subject to a regulatory scheme enforced by the FDA. • A cornerstone of the 1976 device law is the concept of regulation based on risk. Devices on the market at the time the original law was passed were assigned to one of three "classes." Those presenting the least risk, such as elastic bandages, are placed in Class I under the law and are subject to "general controls." Class II devices, presenting greater concern, are subject to additional "special controls" such as premarket notification, postmarket surveillance studies, and performance standards. Class III devices, which include many implanted and life-supporting or life-sustaining devices, are subject to more stringent controls and requirements, including a comprehensive premarket review. In general, the Medical Device Amendments of 1976 created two pathways a manufacturer can follow to market a medical device legally: NOD O ~ ~ Cs~ r 2 W s c3a ~ W O

1) through a premarket notification, known as a"510(k);" and 2) through a premarket approval application (PMA). Additionally, for purposes of marketing approval, the 1976 law distinguished two categories of devices: 1) pre-amendment devices - thos-s in commercial distribution before May 28, 1976; and 2) post-amendment devices - those first commercially distributed after May 28, 1976. All post- amendment devices require pre-approval or clearance from the FDA before they may be marketed. Pre-amendment devices may continue to be marketed lawfully, but FDA is expected, over time, to require PMA's for all pre-amendment Class III devices. • Under the 510(k) process, a determination is required as to whether a device is "substantially equivalent" to a legally marketed device. At least 90 days before a firm intends to market a device for the first time, the firm must submit an application with information that will enable the Agency to make that determination. If the new device is found substantially equivalent, the product sponsor can then market the product. Prior to November 1990, if the Agency did not act within the 90 days, the firm could go to market. The SMDA, however, required an affirmative order of substantial equivalence before marketing clearance is granted. Each year, the Agency receives several thousand 510(k) submissions.

In general, new devices in Class III that are not substantially equivalent to a pre-1976 device require the submission of a PMA. A PMA must provide reasonable assurance of safety and effectiveness for the device's intended use. PMA's typically are very complex and include extensive clinical data. Relatively few, 40-60>, are submitted each year. Any change in an approved PMA'd device that affects the device's safety and effectiveness, such as new indications, labeling revisions, or changes in.manufacturing, also must be approved by FDA through the submission of a PMA supplement. • There are two other types of medical device applications: an Investigational Device Exemption (IDE) application and IDE Supplements. An IDE is necessary to permit a firm to introduce an investigational device into interstate commerce for the purpose of testing the device in human clinical studies. The IDE applies to investigational studies gathering safety and effectiveness data for a medical device that presents a significant risk to humans. Clinical studies that pose a non-significant risk are subject to abbreviated requirements that include approval by the local institutional review board, but no review by FDA. An IDE Supplement is required for any changes in the investigation plan contained in an IDE. Most medical devices are reviewed by the FDA's Center for Devices and Radiological Health (CDRH). FDA's Center for Biologics Evaluation and ~ O Research (CBER), however, reviews those devices that are determined to ~ ~ 4 W ~ ~ i`:

• • • be biologics under the Public Health Service Act or that are used in conjunction with such a biologic. The corresponding application equivalents to PMA's and IDE's for approval of devices that also are biologics is the Product License Application (PLA), and Investigational New Drug application, respectively. The number of applications (PMA, PMA Supplement, 510(k), IDE, and IDE Supplement) submitted annually to FDA has increased steadily since enactment of the Medical Device Amendments in 1976. only 6,000 applications were submitted in 1982. FDA expects close to 12,000 to be submitted in 1994. This number is projected to reach more than 14,000 by 1999. In addition, the number of registered device establishments has tripled since 1980 from approximately 6,000 to over 18,000. In the last decade, businesses registering with FDA have averaged 100-150 each month. These increases in applications and establishment registrations, combined with the increasing complexity of new technologies, have contributed to an increase in medical device applications now pending review. As of June 30, 1994, pending applications at CDRH numbered 4,433 510(k)'s, 143 PMA's, and 424 PMA supplements. While the statutory timeframes for review of 510(k)'s and PMA's are 90 days and 180 days, respectively, the average review times as of that same date, were 173 days for 510(k)'s and 437 days for PMA's. ~ O 5 ~ ~ C,O W ~ W

• • In 1992, increasing public concern about product injuries and deaths from marketed products, including Shiley heart valves, temporo mandibular joint (TMJ) implants, and breast implants, and other circumstances led the Subcommittee on Oversight and Investigations (O&I) to conduct a thorough investigation of the medical device review process. In May 1993, the Subcommittee issued a report entitled, Less than the Sum of Its Parts: Reforms Needed Management, and Resources of the Food for Devices in the Organization, and Drug Administration's and Radiological Health. The Subcommittee's assessment on the state of process and made numerous recommendations management and process reforms. the Subcommittee had "no doubt" CDRH. report offered the Center the medical device review for improvement, including The report also noted, however, that about the need for more resources at The Agency took this report and its findings and recommendations very seriously. Indeed, I want to assure all Members of Congress that the delays in processing of applications and concerns about management are of significant concern to FDA. The Agency is well aware of the important contributions the medical device industry makes to both our nation's health and economic well-being. We want to do our part to bring beneficial products into the marketplace in a sound, expeditious manner. At the same time, however, we must not forget that FDA is a~ C public health agency responsible for consumer protection; we have a ~ clear statutory responsibility to ensure that dangerous devices do not~p

enter the marketplace and that approved devices are marketed appropriately. Thus, the product evaluation process must be sufficiently rigorous and dependable, as well as prompt. The protections afforded the American consumer, and the benefits provided the medical device industry, through this review process cannot be underestimated. • FDA MANAGEMENT INITIATIVES Improvements have been made at CDRH before and after the issuance of the O&I Subcommittee Report and are continuing today. Dr. Bruce Burlington, who assumed his position of Center Director in February 1993, has made improving the device review process his top priority. The Agency's long-term goals in this area include the implementation of a comprehensive management plan for CDRH. This plan was developed with the aim of improving the decision-making processes and the day- to-day operations of CDRH, while assuring a high standard of scientific evaluation upon which premarket decisions will be efficiently and effectively made. Several initiatives have been undertaken to reduce the backlog and to regain predictability and consistency in premarket review, reduce delays, improve CDRH's ability to evaluate applications, and improve communications with regulated industry. These include: ~ © MP ~ C,D ~ 7 C,O ~ ~

• • Implementing a "fast track" review system for life saving devices and for those that offer decidedly greater clinical benefits or lower risk than existing devices. We need to assure that medical devices representing major advancements in medical care reach the market without delay. Devices granted expedited review status will be placed at the beginning of the appropriate review queue and not handled under the usual "first-in, first-reviewed" policy. • Providing strong support to the Division of Small Manufacturers Assistance, whose job is to counsel device companies on the regulatory "rules of the road." The division also serves as a clearinghouse for over 1,000 publications that offer information on a wide range of topics, including development of premarket applications and compliance with GMP requirements. • Disseminating new guidance on application development to help industry understand what constitutes quality clinical studies in terms of statistical design, methodology, etc. To augment this effort, Center experts are working with advisory panels to develop guidelines for specific product types, in addition to training device companies on proper study design through live and satellite conferencing. In addition, public and electronic dockets now provide wide scale access to Center policy documents, guidance, and other essential materials. • Implementing a new risk-based approach to premarket review. The O&I subcommittee report recommended we reduce the burden of ZZd O 510(k)'s for products that present a low health risk. Under the ~ ~ W CO ~ 8 C, ~

• • • new three-tiered review system adopted by CDRH, the most complex devices and those with the highest degree of inherent risk are assigned to "Tier III" and are subject to an intensive scientific and labeling review. Advisory panel input will be sought for the majority of devices in Tier III. The lowest risk Class I devices and some Class II devices are placed in Tier I, and receive only an administrative "labeling review" for intended use and not a full "scientific review." Tier II devices receive an intermediate level of review. • Establishing a "refusal-to-file" policy for device applications. This will eliminate unproductive time spent by both the Agency and the manufacturer when an application lacks necessary information or data is poorly presented. This policy specifies the minimum criteria for accepting an application. If these criteria are not met, the application is not accepted for review. • Integrating more of Center research staff into the review process. Also, the Center is hiring additional clinicians and arranging with expert scientists from other FDA components to contribute to the reviews of certain applications. • Forming a staff college to train newly-hired staff and provide education to in-service staff. • Developing a computerized system through which manufacturers can obtain a status report on their 510(k)'s by fax. The system will ~ O provide the 510(k)'s relative position in the review queue and theWp 9 ~ Cs7 W ~2