The FDA charges a fee for medical device product reviews, including 510(k)s, PMAs, Product Development Protocols
(PDPs), Biologics Licensing Applications (known as BLAs, these are certain medical devices reviewed by FDA’s Center
for Biologics Evaluation and Research), and certain supplements to those types of applications. The fee must be paid for
these types of applications, unless the applicant is eligible for a waiver or exemption. Small businesses may qualify for a
reduced fee. Payment must be received on or before the time the application is submitted. If the applicant has not paid all
fees owed, FDA will consider the application incomplete and will not accept it for filing.
