Device tracking guidance now includes skin grafts
This article was originally published in The Silver Sheet
Executive Summary
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...
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
Health And Wellness Weekly Trademarks Review: 16 April
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.
Beauty Packaging Producers: July Marks Registration Deadline With PRO In Three States
Companies considered producers of single-use packaging in Oregon, Colorado and California must register with Circular Action Alliance, the leading (and currently only) producer responsibility organization, by 1 July 2024 under new state recycling laws.