The U.S. Food and Drug Administration (FDA) has issued a draft Guidance on transferring a premarket notification (510(k)) clearance from one person to another.
The FDA estimates that there are more than 2000 instances of more than one party claiming to be the holder of a 510(k) clearance for a specific device under the agency’s annual registration and listing process. Published in the Federal Register in mid-March, the draft Guidance identifies potential documentation that a party could submit to the FDA to establish the transfer of a 510(k) clearance, thereby helping to reduce the number of conflicting claims.
Guidance documents are intended only to reflect the agency’s current thinking on a given subject and do not have the force of law. However, they can provide device developers and manufacturers with critical information to ensure an efficient device review process and a successful outcome.
Comments on the draft Guidance must be submitted by April 12th and should be emailed to oira_submissions@omb.eop.gov. All submissions should reference both Docket No. FDA-2014-D-1837, OMB control number 0910-New, and title “Transfer of a Premarket Notification.”
Read the complete text of the FDA’s Guidance as published in the Federal Register.
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