Tuesday, June 17, 2014

More Time To Respond To CDRH Classification Reform Proposal

More Time To Respond To CDRH Classification Reform Proposal-thegraysheet: FDA will give companies and other stakeholders an additional three months to provide written comments in response to the agency’s March 25 proposed updates to medical device classification regulations. The agency says it is responding to feedback that the initial 90-day comment period scheduled to expire on June 23 “does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule.” The new comment deadline is Sept. 22.