The House Committee on Energy and Commerce's Subcommittee on Health held a hearing last week examining the Food and Drug Administration's (FDA) regulation of medical devices, including whether additional regulatory steps are necessary for the safety, effectiveness and quality control of medical devices.

The hearing witnesses included Marcia Crosse of the Government Accountability Office; William H. Maisel, M.D., M.P.H., Director Medical Device Safety Institute, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Phillip J. Philips, Independent Consultant; and Peter Lurie, M.D., M.P.H., Deputy Director, of the Health Research Group for Public Citizen.

In his opening statement, Committee Chair Frank Pallone said, "There is evidence of an approval system [that] is broken -- that its standards, its procedures and its rules don't meet modern needs of getting medical devices to those in need with confidence in their safety."
Ms. Crosse, Director of Health Care for the GAO, described the GAO's study on the FDA's Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments. According to Ms. Crosse, the study found that: the FDA does not review all class III devices through its most stringent premarket review process, there are shortcomings in FDA's postmarket oversight (for instance, the FDA cannot review the entire volume of reports regarding risks related to the use of medical devices), and FDA has not conducted required inspections of manufacturing establishments.

Mr. Maisel stated that to best protect the health of patients, the FDA needs to have a higher scientific standard for device clearance and approval. Mr. Maisel said this includes clarifying the status of higher risk 510(k) class III devices (some of which are still cleared via the 510(k) process rather than the more stringent Premarket Approval process) in particular for modifications to a device. As example, Mr. Maisel pointed out that manufacturers are required to maintain documentation of self-conducted regulatory analyses, however are not required to submit documentation or to even notify the FDA that device modifications have been made. "It is apparent," Mr. Maisel testified, "that manufacturers have performed numerous other device modifications without the FDA's knowledge and without the Agency's ability to track these changes or their impact on device safety."

Mr. Philips, however, urged caution before drawing conclusions that the 510(k) program was inadequate, and that more devices should be subject to the more stringent PMA requirements, saying "most of the creativity in the device industry originates from small entrepreneurial companies that are the least prepared to satisfy these demanding requirements." Mr. Philips further stated that the 510(k) program should not be judged on "dissatisfaction expressed over a relatively small number of agency decisions." He pointed out the over 14 million devices cleared through section 510(k) since 1976 "while the examples cited by the critics in support of changing the program are extremely few."

Finally, Mr. Lurie testified that Congress should raise the standard for medical device approval to that required for drugs. "Sponsors of devices that claim to treat diseases should produce "substantial evidence," rather than merely "reasonable assurance," of effectiveness. Such devices would have to meet the same requirements as drugs, including more than one well-controlled trial." Mr. Lurie also suggested that the FDA should tighten its working definition of "same intended use," and direct new devices with weaker "same intended use" claims to the PMA process. In addition, Mr. Lurie proposed that the "different technological characteristics" provision of the 510(k) review be repealed (where predicate devices with such characteristics are allowed if there are no safety or effectiveness issues) and such devices be directed to the PMA process.

Based upon the testimony available on the House Subcommittee on Health's website.

Link: http://energycommerce.house.gov/index.php?option=com_content&view=article&id=1677:energy-and-commerce-subcommittee-hearing-on-medical-devices&catid=132:subcommittee-on-health&Itemid=72

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