![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Plastic Surgery Foundation Receives IDE Approval
Plastic Surgery Foundation Receives IDE Approval
The FDA has approved an Investigational Device Exemption (IDE) request by the Plastic Surgery Foundation for a study of surgical mesh used in breast reconstruction.
The IDE allows the foundation to sponsor an observational trial studying the impact of surgical mesh, including acellular dermal matrix, in implant-based breast reconstruction.
No surgical mesh devices have received FDA’s approval for any breast reconstruction indication. The organization hopes to develop scientific evidence that would lead to a Premarket Approval Application.
The first patients are expected to be enrolled in the study in early 2023.
Upcoming Events
-
18Jul
-
21Oct