Submitted by kBLASTER Team on
by kBLASTER Team
The FDA recently released two final guidances on Medical Device Data Systems (MDDS) and Mobile Medical Applications. Both of these were guidances were released simultaneosly and intended to be consistent with each other. The goal of these guidances was to clarify for MDDS and/or Mobile Medical Apps products when the FDA does not intend to enforce compliance with regulatory controls (i.e., products are not regulated by FDA) vs. when a product may be a regulated medical device either by its classification and/or routed through the 510(k) exempt, 510(k) clearance or PMA approval process.
This is an initial announcement of final guidance releases and will be followed by more in depth analysis of individual guidances.
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