In December the FDA issued two rules that will affect the classification and reclassification of medical devices. The first rule, which will become final on 18MAR2019, the agency is amending 21 CFR Part 860 to establish new processes for PMA applications for preamendments devices and reclassification of devices. Under the new process, the agency would publish an administrative order in the Federal Register, accept and consider draft comments on the order, and hold a device classification panel meeting before publishing the final order either requiring a PMA for a class III preamendment device or reclassifying a device. The changes allow the agency to comply with statutory requirements under the Food Drug Administration Safety and Innovation Act (FDASIA), which removed the rulemaking requirements and allowed manufacturers of class III preamendments devices to market their device after receiving clearance through the 510(k) process until and when the agency requires a PMA for that device. The new rule is expected to increase the clarity, predictability and uniformity of these processes for both the agency and sponsors.

The second rule, open for public comment until 07MAR2019, will establish regulatory rules for the medical device De Novo classification process. This process has been handled under the De Novo guidance issued in October 2017 (which is still active). However, the agency has found that some requests submitted per the guidance lack crucial information and require additional information requests and lengthy reviews. The proposed rule will establish the specific requirements of the De Novo process for both sponsors and the agency, which should reduce the number of questions during review and the total review time. I expect this proposed rule will move to a final rule in 2019. There may be updates to guidance following rule issuance.

Text Copyright © 2019 Katrina Rogers