USA – CDRH Fleshes Out Guidance on Application of Least Burdensome Provisions

The US Food and Drug Administration (FDA) on Monday published final guidance on the FD&C Act’s least burdensome provisions for the regulation of medical devices, highlighting recent initiatives via newly added themes.

The 24-page document, which finalizes a draft from December 2017, is intended to reflect guiding principles that require “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time.” The term “relevant” was added to the definition in the draft, underscoring the goal of minimizing regulatory-related administrative burden throughout the medical device total product lifecycle (TPLC).

Updates to FDA’s final guidance from 2002 were prompted after the enactment of additional least burdensome provisions under more recent legislation, including the Food and Drug Administration Safety and Innovation Act of 2012 and the 21st Century Cures Act of 2016. The draft scope was expanded to include waivers by application under the Clinical Laboratory Improvement Amendments and to clarify that the statutory medical device definition covers device constituent parts of combination products.

The final guidance is largely similar to the draft. It includes, however, new clarifications that promote relatively new initiatives within FDA and industry and are closely aligned with least burdensome principles. These relate to “just-in-time testing,” the use of FDA-recognized voluntary consensus standards, device submission efficiencies and FDA feedback regarding inspectional observations from device manufacturing facilities…