for Reprocessed Single Use Devices
Standards are useful in premarket submissions for reprocessed single use devices (SUDs). The following FDA guidance documents about standards are recommended:
- Use of Standards in Substantial Equivalence Determinations, explains how consensus standards may be used in premarket submissions.
- Recognition and Use of Consensus Standards; Final Guidance for Industry and Staff, provides guidance to FDA Staff and industry on the recognition and use of national and international standards, including declarations of conformity to these standards, during the evaluation of premarket submissions.
- Frequently Asked Questions on the Recognition of Consensus Standards; Guidance for Industry and for FDA Staff, was developed to answer frequently asked questions concerning FDA's implementation of section 514(c) of the Food, Drug, and Cosmetic Act (the Act), which addresses FDA recognition of consensus standards to satisfy certain regulatory requirements. The guidance will periodically be updated as new questions are asked of the Agency and as the recognition of standards by FDA increases and the use of standards by the industry grows.
- Standards recognized by FDA that may be useful to reprocessors of single-use devices, such as those for sterilization, biocompatibility, and safety/performance, can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.