From: Politico | Morning eHealth
FDA LAUNCHES MEDICAL DEVICE PLAN: FDA expects this fall to update its cybersecurity guidance, which will describe how device manufacturers should build products hardened against cyber-borne attacks, Commissioner Scott Gottlieb said in a wide-ranging speech on medical device regulations Wednesday.
The speech was otherwise notable for the announcement of the agency’s “QUik Review” pilot, which intends to speed review times for certain low-risk device applications in the agency’s 510(k) program.
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