1. Life Sciences

FDA Drafts Guidance on Pre-market Submissions for Patient-Matched Guides to Orthopedic Implants – Duane Morris Life Sciences Law




This summer, the U.S. Food and Drug Administration (FDA) issued draft guidance regarding patient-matched guides to orthopedic implants, which are intended to assist in the execution of a pre-surgical plan concurred upon by the patient’s healthcare professional to position an orthopedic implant in a way consistent with the implant’s indicated use. In the draft guidance, FDA recommends information to include in pre-market submissions for patient-matched guides to orthopedic implants. FDA also suggests information for manufacturers to consider when creating the design process for patient-matched guides.

To read the full alert, visit the Duane Morris website.



Comments to: FDA Drafts Guidance on Pre-market Submissions for Patient-Matched Guides to Orthopedic Implants – Duane Morris Life Sciences Law

Login

Welcome to Life Science News!

"Explore the Latest Discoveries and Breakthroughs in Life Science with Life Science News!"
Read Smart, Save Time
Pick all the topics you are interested in to fill your homepage with stories you'll love.
Join our community
Registration is closed.