Medical Device Link.

Originally Published PMPN July 2003

NEWS

FDA Exemption Ends for Some Reprocessed SUDs 

Erik Swain

FDA has ended its exemptions from filing premarket notification 510(k) applications for some manufacturers of reprocessed single-use devices (SUDs). 

Reprocessing, which often includes repackaging, of devices intended for single use has been a controversial issue for several years. Many medical device manufacturers are not in favor of the practice, citing safety issues. However, many hospitals and third-party firms that perform reprocessing say the practice reduces costs and is safe if done properly. FDA’s notice is part of its efforts to regulate the practice more thoroughly. It is based on specifications from the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). That law called for some reprocessed SUDs previously exempt from the 510(k) process to be proven substantially equivalent to predicate devices.

In the April 30, 2003, Federal Register [68 FR:23139–23148], FDA issued two lists. The first notes critical reprocessed SUDs for which validation data must be submitted in a 510(k). The second notes such devices that were previously required to submit a 510(k) application and now also have to include validation data. 

Manufacturers of devices on the first list must submit a 510(k) to the agency by July 30, 2004, or else no longer be allowed to market their device. Manufacturers of devices on the second list must submit validation data to the agency by January 30, 2004, or else no longer be allowed to market their device. The lists can be viewed at www.fda.gov/ohrms/dockets/98fr/03-10413.html. 

FDA’s next task will be to evaluate semicritical reprocessed SUDs and determine which must file 510(k) applications. MDUFMA requires the agency to identify those products by April 26, 2004. MDUFMA does not require any action for noncritical reprocessed SUDs. 

Copyright ©2003 Pharmaceutical & Medical Packaging News