New Draft PMA Filing Guidance Outlines Rejection Rules
A new draft guidance aims to expedite the device approval process by clarifying the reasons the FDA can reject a PMA during the acceptance and filing process.
300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 - Fax (703) 538-7676 - Toll free (888) 838-5578.
Copyright by FDAnews. All rights reserved. Do not duplicate or redistribute in any form.