FDA revises guidance on reprocessing of single-use devices

Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug Administration (FDA) today announced the availability of a revised guidance covering the agency's procedures and timeframes for reviewing the validation data submitted to FDA for certain reprocessed single-use devices (SUDs).

The new document, entitled "Guidance for Industry and FDA Staff; Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices", supersedes a guidance of the same title issued last year.

The July 8, 2003 guidance described the types of validation data that FDA recommends be submitted on cleaning, sterilization and functional performance of certain reprocessed single-use devices to ensure that they are substantially equivalent to the original products. The document also provided guidance on how the agency intends to implement these validation data requirements, which were enacted by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

The main revisions in the revised guidance describe in more detail the timeframe for FDA's reviews of these validation data submissions, and what actions the agency intends to take if it finds a reprocessed single-use device to be not substantially equivalent (NSE) to the original SUD.

The new guidance makes clear that following its review of the supplemental validation submission, the FDA intends to issue either a letter finding the reprocessed SUD to be substantially equivalent (SE) to the original device, or a letter requesting additional information. The manufacturer who receives the request for additional information will have 30 days to respond, and then FDA intends to make a final decision on substantial equivalence within 60 days.

If the agency reviews the validation data and determines that the reprocessed SUD is not substantially equivalent (NSE) to the predicate device, it will issue an NSE letter. Thereupon, the device may no longer be legally marketed. The manufacturer may submit a new premarket notification (510(k) with the validation data required by MDUFMA at a later date.

The MDUFMA requirements apply to critical reprocessed SUDs, which contact normally sterile tissue or body space, and to semi-critical SUDs, which contact intact mucous membranes without penetrating normally sterile areas of the body. Two years ago, an FDA survey found that more than 45% of all hospitals with more than 250 beds reuse SUDs ranging from compression device sleeves to endoscopic/laparoscopic instruments and electrophysiology catheters.

The revised guidance is posted on FDA's Web page at www.fda.gov . The recommendations are effective immediately, but remain subject to comments that can be submitted to http://www.fda.gov/dockets/ecomments .