HIMA reuse petition
This article was originally published in The Gray Sheet
FDA denies a Health Industry Manufacturers Association request to regulate as manufacturers commercial reprocessors of disposable medical devices. The agency maintains in a July 15 response that compliance by reprocessors with good manufacturing practices "provides an appropriate measure of public health protection...by ensuring sufficient control over the individual firm's manufacturing and quality assurance operations." FDA notes the "current general absence of evidence of adverse patient outcomes attributed to the reuse of single-use devices." Instead of applying premarket requirements to reprocessors, as HIMA had requested in its September 1997 petition ("The Gray Sheet" Sept. 15, 1997, p. 6), FDA "will continue to rely on labeling and existing postmarket requirements"
You may also be interested in...
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
Among the largest gaps in safety data is non-clinical research on CBD use's effect on developing fetus and adolescent brain, in utero/lactational exposure, reproductive toxicity and the potential for a latency period before toxicity, says FDA neuroscientist Andrew Shen.
The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.