RAPS

Updated: FDA Classifies Three Radiology Devices Into Class II

Editor's note: This article has been updated to reflect the release of an updated guidance related to medical image analyzers. The US Food and Drug Administration (FDA) on Tuesday classified two ...
JD Supra

Unpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance?

It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found is ...
American Hospital Association

CMS, FDA announce pathway to expedite access to certain medical devices for Medicare beneficiaries

The Centers for Medicare & Medicaid Services and the Food and Drug Administration April 23 announced a new pathway to ...
RAPS

FDA Moves Three Device Types into Class II Special Controls

The US Food and Drug Administration (FDA) has proposed classifying three types of medical device products into its Class II regulatory controls scheme, subjecting them to special controls meant to ...