2018 Year-End FDA Medical Device Highlights Include Proposed Changes

From Barnes & Thornburg LLP:

In case you thought your year-end was busy, there was quite a bit of activity at the FDA’s Center for Devices and Radiological Health (CDRH). This alert summarizes four significant developments: (1) a controversial proposed revision to the 510(k) process; (2) a proposed rule on the de novo classification process; (3) a final guidance on the breakthrough device program; and (4) a report on inspections/enforcement and quality.

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