PubMed · 9147626
The source did not provide an abstract. Follow the original record for more information.
Explore connections, maps & timelines
S K Pandya. Re-using disposables intended for single use.. https://pubmed.ncbi.nlm.nih.gov/9147626/
Cite the original work for its findings. Save a collection to share your selection of sources.
KEEP EXPLORING
The Food and Drug Administration (FDA or we) is amending certain classification regulations for reprocessed single-use devices (SUDs) whose exemption from premarket notification (510(k)) requirements have been terminated and other reprocessed SUDs already subject to premarket notification for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a 510(k). Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. This action codifies actions taken in previous Federal Register notices in accordance with MDUFMA.
Explore the source record for details and available documents.
Explore the source record for details and available documents.