MDDI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

FDA Revises Postmarket Surveillance Guidance

CDRH has consolidated its postmarket surveillance guidances into a single document to make it easier to access information. The new document, released today, mostly takes the form of a FAQ. Issues covered include the policy criteria CDRH uses to determine whether to impose postmarket surveillance, the responsibilities of the various review team members, and notification issues. With postmarket issues becoming more of a priority at CDRH, this document should come in handy.

500 characters remaining