An MD&DI February 1998 Column
WASHINGTON WRAP-UPThe FDA Modernization Act of 1997 makes many changes to the agency requested by the medical device industry.
A lthough they came to Capitol Hill nearly four years ago de manding release from FDA oversight, in November most members of the medical device industry felt satisfied with the compromises they had obtained. The FDA Modernization Act of 1997 addresses every cogent industry complaint made about FDA policy and practice since the reform movement began.
For example, no fewer than five rights previously granted to FDA by Congress were repealed:
- FDA may no longer cite a company for claiming its product is FDA approved.
- Device distributors no longer need to file medical device reports (MDRs), or register or list their products with FDA (but recordkeeping rules still apply).
- Companies no longer need to annually certify under the MDR rule. User facilities also will be gradually let off the hook, except for their involvement in a sentinel system to be established by FDA. Under this system, FDA will require MDRs from a subset of user facilities that make up a representative profile of health-care providers.
- Not all manufacturers of critical or implantable life-supporting devices will need to track their use by patients and practitioners. Instead, FDA must, under explicit statutory restrictions, specifically order that certain Class III devices be tracked.
- Companies no longer need to submit postmarket surveillance plans for critical, life-supporting, or implantable devices, although FDA may require such plans on a case-by-case basis.
Although these changes may not directly benefit every device manufacturer, they illustrate the revisionist mood that swept Congress in response to industry arguments and FDA's own tacit recognition of its shortcomings.
However, removing old irritations is only a small part of the reform package President Clinton signed into law in November. The new law, which takes effect February 18, contains a number of innovations. The Medical Device Manufacturers Association and HIMA have drafted excellent analyses of these changes.
Under the new act, all Class I devices are exempt from 510(k) premarket notification unless they are intended for a use of substantial importance in preventing the impairment of health or unless they potentially pose an unreasonable risk of illness or injury. The Senate-House conference committee report specifically states that FDA cannot reclassify low-risk Class I devices to a higher category simply to avoid exempting them under this provision. In addition, the agency must publish, by January 20, a list of Class II devices that are exempt from 510(k) requirements. Other devices may be exempted later by FDA as a result of its own judgment or after a manufacturer-initiated petition process. FDA must process such petitions within 180 days or they will be deemed granted.
The new law also shortens 510(k) review times by requiring FDA to consider the extent to which postmarket controls may expedite the classification process, to seek only the least burdensome evidence of substantial equivalence, and to base substantial equivalence decisions on only those intended uses detailed in the proposed labeling. The Office of Device Evaluation may still require a label to state information about uses other than those intended by the manufacturer if there is a reasonable likelihood that the device will be used for such a purpose and that such use could cause harm. Decisions on 510(k)s still are held to the current 90-day deadline.
Reviews for 510(k) submissions also should see faster turnarounds because FDA is to expand its pilot program for independent reviews. All devices will be eligible for third-party review except for Class III devices, Class II devices that are intended to be permanently implantable or life-supporting, and devices requiring clinical data to support their 510(k). FDA has 30 days to act on an independent reviewer's recommendation.
In addition, FDA must provide review priority for devices that represent breakthrough technology, have no approved alternative, offer significant advantages over existing alternatives, or are in the best interest of patients.
Premarket approval (PMA) application review times will be expedited by creating a collaborative review process. In this process, device sponsors will now have a statutory right to meet with FDA within 100 days of its receipt of their submission to discuss any problems. The review will then proceed on a mutually agreed-upon schedule. FDA may also use any company's PMA clinical or preclinical test data, six years after approval, for the purpose of approving another company's device, determining if a product development protocol has been completed, establishing a performance standard or special control, or (re)classifying another device.
Among other compromises obtained, device sponsors may participate in device classification panels and access the nonconfidential data to the same degree as FDA. Also, under strictly limited circumstances, companies may disseminate peer-reviewed and certain other forms of information about FDA-unapproved uses of their legally marketed devices to health-care practitioners, pharmacy benefit managers, health insurance issuers, group health plans, or government agencies.
Finally, FDA guidances must be available to the public in written andwherever feasibleelectronic format during their development. Moreover, FDA employees must be trained in the legal status of guidancesespecially that they are not enforceable.
These changes are just a few of the myriad reforms contained in the new law. This law also provides a solid foundation for FDA's recent, self-initiated probusiness reforms. For starters, it gives FDA its first statutory mission statement, directing the agency to improve employee training and requiring it to ensure that its GMP rules conform "to the extent practicable" with internationally recognized quality system standards for medical devices. The act also requires FDA to support the Office of the U.S. Trade Representative in harmonizing regulatory approaches and achieving mutual recognition agreements with other countries.
FDA's new, stated mission encompasses promoting public health through the efficient review of clinical research and taking timely, appropriate action on marketing applications; protecting public health by providing reasonable assurance of the safety and effectiveness of devices; reducing international regulatory burdens and harmonizing requirements; and carrying out its duties in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, and manufacturers.
Somewhere in the final stages of the act's travels through Congress, it lost the words "and Accountability" from its title. This is not to say that Congress won't hold FDA accountable for its performancenumerous "hammer" provisions require the agency to publish within set deadlines, and it must report its progress to Congress after one-year and five-year periods. In addition, both the General Accounting Office and the Congressional Budget Office will certainly be conducting formal, in-depth investigations of FDA's responses to the new law.
On top of all that, section 406 of the new law requires FDA to develop and publish, within one year, a detailed plan for meeting its statutory obligations. These obligations include establishing a mechanism to ensure compliance with all statutory deadlines by July 1, 1999, and eliminating all backlogs by January 1, 2000. FDA also must publish an annual report in the Federal Register, permitting opportunity for public comment, that describes how it is complying with the act. This report must include statistical information on its performance to date and identify any regulatory policy that has had a significant negative effect on the agency's performance.
Thus, in addition to its congressional watchdogs, FDA will have to contend with the scrutiny of its other diverse constituencies, especially those that have been the most critical in the past. FDA would be wise to keep its doors open to this input during the year so it can address comments in its annual report. The act contains so many reporting provisions now that it almost makes the words that were deleted from the bill's title, "The FDA Modernization and Accountability Act of 1997," sound like overkill.