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Device Center Discord: 510(k) Review Process Is Flash Point At CDRH

This article was originally published in The Gray Sheet

Executive Summary

Details trickling into the public sphere about CDRH's device review process reveal heightened tension between reviewers and management over the proper response to a 510(k) submission

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Appeals Court Checks FDA On Its 510(k) Rescission Authority

In a 2-1 opinion, a federal appeals court ruled that FDA can’t use rescission to reverse a 510(k) clearance if the more time-consuming device reclassification process can accomplish the same ends. The decision sends a collagen knee scaffold device, which previously caused major contention inside FDA, back to the agency for a decision, but more court review might be ahead.

Regulatory News In Brief

CDRH issues simplified SOPs for resolving differences of scientific, regulatory or clinical opinion among staffers. More regulatory news.

Washington Roundup, August 2012

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we report on recent FDA proposals to streamline the 510(k) and PMA submission processes and the ongoing investigation into FDA surveillance of CDRH employee whistleblowers.

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