Device tracking guidance now includes skin grafts
This article was originally published in The Silver Sheet
FDA has updated an industry guidance for manufacturers that have been ordered by the agency to track specific products. "Medical Device Tracking," found online at www.fda.gov/cdrh/comp/guidance/169.pdf and released Oct. 25, has added "cultured epidermal autografts" to the list of device types for which FDA requires firms to track individual products to facilitate notification and recall. The change was prompted by the Oct. 25 humanitarian device exemption of the Epicel skin graft, which are sheets of skin cells used to replace the top layer of skin on patients with severe burns
You may also be interested in...
GSK creates another partnership centered on its vaccine adjuvant technology, this time with China's Xiamen Innovax.
Lab testing for COVID-19 has risen to a new high of 314,000 tests per week in Germany, where the concerns are perhaps less about test availability than staff numbers to oversee the testing protocols.
A new European Commission guidance document explains the regulatory basics and much- altered emergency market entry criteria for new entrants to devices sector amid the COVID-19 crisis.