For more than two years, the Food and Drug Administration (FDA) has contemplated deeper involvement in medical device regulations and changes to its 510(k) medical device approval process. Two factors seem to have motivated this shift: the emergence of Apple Inc. iOS and Google Inc. Android applications that turn smartphones into makeshift medical devices; and, tellingly, the fast-tracking of medical devices without sufficient testing.
Last week the FDA’s Center for Devices and Radiological Health (CDRH) released 25 recommendations for new medical device regulations. Highlights of the changes (and key dates involved for each one) include the following:
- Draft guidance on clinical data (including photographs and schematics), as well as the criteria for naming “different questions of safety and effectiveness” when applying for a 510(k) clearance, will be published by Sept. 30.
- The CDRH will form a Center Science Council to respond to scientific and technological advances and adjust medical device regulations accordingly. This council’s charter will be published by March 31, and an initial 510(k) program audit is due by June 15.
- The CDRH will issue a proposed regulation for a unique device identifier system by June 30.
- A public meeting on April 7 and 8 will discuss proposals for a public database of device photographs (sans proprietary information) and an online medical-device labeling repository. Proposed regulations for submitting labels will be issued by Dec. 31.
In addition, several matters have been referred to the Institute of Medicine (IOM), which will publish a report this summer. These issues include the need for surveillance studies once a medical device has been released and the potential for manufacturers to submit an actual device to the CDRH when a product is under review.
As the Associated Press reported, the revisions to medical device regulations are modest. For example, the FDA had considered putting health information technology into its Class I; these are devices that do not directly support life and, as a result, do not present a risk of serious injury This would have involved general regulatory control of medical devices and would have brought the FDA into the process of IT regulation. Under the new FDA recommendations, nevertheless, these devices remain in Class III, which includes pacemakers and other instruments that directly support and sustain a patient’s life although the IOM has been asked to help define Class IIb devices, which would fall somewhere in the middle.
This modesty has left device manufacturers pleased, but patient safety advocates disappointed. To be fair, the FDA has set some rigorous deadlines for crafting its new medical device regulations — no small feat considering that the 510(k) clearance program remains virtually unchanged since 1976 — and has been busy with the challenge of regulating electronic health record software.
Overall, with a bevy of medical devices expected to hit the market in the name of home health and preventive care, the FDA will have to walk a fine line between a quick clearance process and a thorough one.