Submitted by kBLASTER Team on
On February 24, FDA hosted a webinar with an accompanying slide deck to discuss final guidance documents on medical device data systems (MDDS) and mobile medical apps (MMA), as well as draft guidances on our general wellness policy for low risk devices and medical device accessories. The intent was to give an overview of FDA’s approach to regulating MDDS and MMAs and to help stakeholders understand the draft policies described in the general wellness products (GWP) and medical device accessories guidance documents and solicit comments. A key goal of the webinar was for FDA to clarify which medical devices are of such low risk that FDA will no longer focus regulatory oversight on them or FDA will regulate them under a lower risk classification, narrowly tailoring FDA's approach to the level of risk to which patients or consumers are exposed.
The FDA speakers fielded numerous questions from webinar participants from industry regarding MDDS, MMAs and GWPs that revolved back to same central question--will the FDA enforce regulatory oversight with regards to design controls, registration and listing, labeling, device identifiers, surprise audits, etc, for products that FDA says are "low-risk products" as designated by MDDS and GWP or fall under the MMA category of "enforcement discretion"? The FDA repeated resoundingly, to more than a dozen variations of the same central question, that FDA does not intend to enforce regulatory compliance on any of these. FDA did give a specific example if radiology images were used for primary diagnosis via a MMA, this would fall under medical device regulatory compliance requirements for a currently regulated medical device as a Picture Archiving and Communication System (a class II, 510(k) cleared medical device) that would require 510(k) clearance before marketing. It was clearly communicated by FDA that it will be up to MDDS, MMA and GWP manufacturers to correctly interpret these guidances, including examining their product through the lens of currently regulated medical device products, to determine if a product in question will be an FDA regulated product or not.
Following the webinar, a transcript, recording and slides will be available.
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