The FDA is withdrawing 47 draft guidance documents published before the end of 2013 that it never finalized or acted on.
Agency officials posted the announcement in the Federal Register, explaining that the move is designed to boost efficiency and transparency regarding its development of guidance documents.
The soon-to-be-banished draft guidances cover areas including face masks for CPR, PMA applications for a testicular prosthesis, medical device interactions with MRI machines, portable blood glucose monitoring in vitro diagnostic devices, electrical nerve stimulators for pain relief, a recommended warning for surgeon and patient examination gloves and more.
The proposed guidances go well beyond medical devices and diagnostics, also affecting pharmaceutical and biotechnology drugs, surgical tools and other areas of medicine.
FDA officials noted in the announcement that regulators’ guidance workload has grown in recent years "due to requests from the public for guidance to clarify specific issues and statutorily mandated guidances."
As a result, many of the draft guidances ended up not being finalized, the FDA said, "most often because of higher priorities and resource issues." What’s more, new information, scientific developments and emerging technologies have simply made some of the draft guidances outdated, regulators said.
At the same time, however, the FDA is allowing comments on any of its specific withdrawn items, and those are due by June 5, either electronically or in writing.