Bone void fillers
This article was originally published in The Gray Sheet
FDA special controls guidance for Class II resorbable calcium salt BVFs should not be applied to demineralized bone matrix (DBM) products, as has been suggested by the agency, Stryker Howedica Osteonics and the Orthopedic Surgical Manufacturers Association recommend in May comments. In a March 12 announcement, FDA indicated that DBMs would be regulated as devices (1"The Gray Sheet" April 29, 2002, p. 5). A separate guidance for DBMs should be issued, according to Stryker and OSMA...
You may also be interested in...
CDRH's decision to require 510(k) submissions for demineralized bone matrix (DBM) products is at odds with previous policy statements by the Center for Biologics Evaluation & Research, the American Association of Tissue Banks maintains in comments sent to the FDA center directors April 19
Device Week, 4 December 2020 – MedWatch Question About Third-Party Servicers Slides Under Industry's Radar
On this week’s podcast: A change made by the US FDA to its MedWatch program that asks adverse event reporters whether a third party serviced a malfunctioning medical device went unnoticed by many in industry for nearly a year. We explain why, and tell how the servicer question will be helpful for manufacturers and the agency.
The series D financing will support the expansion of Everlywell’s consumer lab testing and digital health businesses.