On Tuesday, March 25, the U.S. Food and Drug Administration ("FDA") issued a proposed rule to clarify which medical devices are subject to class III regulations and to change the procedure by which devices can be reclassified based on new information. 

Generally, medical devices are regulated in one of three classes based on FDA's assessment of safety risks and product effectiveness: general controls (class I), special controls (class II), and premarket approval (class III). The proposed rule clarifies that a reasonable assurance of safety and effectiveness ("RASE") is necessary for all three classes. 

In addition, FDA proposes specific changes to aspects of the class II and class III categories. By way of example, with respect to any implantable device and device intended for use in supporting or sustaining human life that is recommended for class II regulation, the FDA classification panel must identify and describe which special controls are necessary to provide RASE. As it relates to class III, the proposed rule enumerates five categories of devices generally subject to premarket approval because of heightened risks:

  • Devices that present known risks that cannot be controlled;
  • Devices for which the risk-benefit profile is unknown or unfavorable;
  • Devices for which a full review of manufacturing information is necessary;
  • Devices for which premarket review of any change affecting safety or effectiveness is necessary; and
  • Combination products (devices that provide the primary mode of action for products that include drug or biological constituents that have not yet been found to be safe and effective, or safe, pure, and potent, respectively).


After a device has been classified, FDA or an interested person may initiate a process to reclassify the device as new information comes to light. The proposal would require FDA to use administrative orders for the reclassification of devices, a process that includes convening a classification panel meeting before or after publishing a proposed order. The proposed order itself would summarize the valid scientific evidence, explaining why the current classification is not sufficient (for changing from class II to class III) or is excessive (for moving from class III to class II). "Postamendments devices" are classified automatically into class III and remain subject to premarket approval filings unless reclassified by FDA. Under the proposed rule, "preamendments devices" and others cleared by substantial equivalence review could be marketed without submission of a premarket application (unless and until FDA issues a final order requiring it). 

This proposed procedure backs away from the more burdensome requirements of notice-and-comment rulemaking sometimes used for device reclassifications. Rulemaking generally requires an FDA advisory committee to recommend the change and FDA to publish a proposed regulation and consider extensive public comments before issuing a final regulation. 

Other proposed changes include removing requirements to answer the classification questionnaire and use the supplemental data sheet and extending the time for filing a reclassification petition, from 15 days to 30 days. With these proposals, FDA aims to streamline the reclassification process and provide greater clarity about the scope of each medical device class. 

Recent legislation already mandates many of these administrative procedures, so it is likely that FDA's final rule will conform in large part to the general principles outlined in its proposal. Members of the public may submit comments on the proposed rule through June 23.