What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More

Regulatory NewsRegulatory News | 11 December 2017 |  By 

While recognizing that comparison testing for 510(k) applicants can be outdated, especially for newer medical devices, the US Food and Drug Administration (FDA) announced Monday that in the first quarter of 2018, new draft guidance will be released to address an alternative pathway for demonstrating substantial equivalence.

The creation of this voluntary, alternative 510(k) pathway, first announced back in September, "will allow more flexibility to use more modern criteria as the reference standard, and permit comparisons to standards that more closely approximate the kind of novel technology we're being asked to evaluate," FDA Commissioner Scott Gottlieb said in a blog post on Monday.

"Under this new framework, device manufacturers could demonstrate substantial equivalence by meeting objective safety and performance criteria," Gottlieb said, including FDA-recognized standards, guidance documents or a combination of the two. 

"This pathway would be available for pre-specified categories of mature devices – those for which safety and performance criteria that meet or exceed the performance of existing, legally marketed devices can be identified," he added. "This approach will also make it easier for FDA to conform its framework for evaluating new products to international consensus standards where such standards exist."

He offered examples of ultrasound imaging machines, common in vitro diagnostic devices and blood pressure monitors.

In addition, in early 2018 FDA will offer draft guidance on when devices may be authorized with a certain level of uncertainty that can be resolved in the postmarket setting.

"Under this form of more progressive review, FDA will outline how it makes judgments about when it's appropriate to place greater reliance on post-market data in order to facilitate access to certain innovation, or when the agency needs to rely more on pre-market data collection because of certain issues related to a particular product or how it may be used," Gottlieb said.

Other prioritized draft guidance coming in FY 2018 will include topics such as multifunctional devices, requests for feedback and meetings for device submissions, and validation of automated process equipment software. Prioritized final guidance for FY 2018 will include topics such as device accessories, unique device identification and the use of public human genetic variant databases to support clinical validity for genetic diagnostics.

CDRH Fiscal Year 2018 (FY 2018) Proposed Guidance Development and Focused Retrospective Review of Final Guidance



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