Insights

FDA Proposes Rule to Clarify Classification System for Medical Devices

FDA Proposes Rule to Clarify Classification System for Medical Devices

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.

Lawyer Contacts

For further information about this proposed rule or medical device rules in general, please contact your principal Firm representative or one of the lawyers listed below. General email messages may be sent using our "Contact Us" form, which can be found at www.jonesday.com.

Mark Mansour
Washington
+1.202.879.3883
[email protected]

Colleen M. Heisey
Washington
+1.202.879.3449
[email protected]  

Christopher M. Mikson, M.D.
Washington
+1.202.879.3738
[email protected]  

Emily K. Strunk
Washington
+1.202.879.3778
[email protected]  

Matthew R. Bowles
Washington
+1.202.879.3604
[email protected]  

Jones Day publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without the prior written consent of the Firm, to be given or withheld at our discretion. To request reprint permission for any of our publications, please use our "Contact Us" form, which can be found on our website at www.jonesday.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship. The views set forth herein are the personal views of the authors and do not necessarily reflect those of the Firm.

We use cookies to deliver our online services. Details of the cookies and other tracking technologies we use and instructions on how to disable them are set out in our Cookies Policy. By using this website you consent to our use of cookies.