New Guidance Signals Expanded FDA Powers over Deficient SUDs

Originally Published MDDI July 2004

NEWSTRENDS

Erik Swain

FDA can now take action against those responsible for some reprocessed single-use devices (SUDs) that have insufficient validation data.

The agency issued a revised guidance document on June 1 that outlined how it will review validation data for 510(k) applications of reprocessed SUDs. The document signaled the end of the grace period for some SUDs to either comply with the requirements or face sanctions. Specifically, the grace period has passed for sponsors of SUDs that had submitted 510(k)s before the new regulations on validation data went into effect April 26, 2003. The grace period for sponsors of SUDs that have had to submit new 510(k)s is scheduled to end in October 2004.

The revised guidance includes the review procedures and time frames the agency intends to follow when processing the required validation data. It updates the July 8, 2003, guidance document that outlined the validation data needed for CDRH to make a ruling of substantial equivalence. 

The document states that after the review of the validation data, FDA will issue either a new letter of substantial equivalence or a letter requesting additional information. If additional information is needed, the agency will issue a letter and allow the manufacturer 30 days to respond. FDA does not plan to grant extensions. If an SUD is found not substantially equivalent, FDA will issue a letter, and the sponsor must remove the product from the market. 

The guidance also notes that FDA is allowed to request validation data even for 510(k) applications of SUDs that are in product categories where such data are not normally required. 

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