Post-approval study is a clinical study or other investigation required in the PMA approval order to gather specific information to address precise study objectives about an approved medical device. Post-approval study commitment is an agreement by the sponsor, and confirmed by FDA in writing, to conduct one or more post-approval studies. Completion of these studies will fulfill that post-approval study commitment.

In post-approval study commitments, drug developers, as a condition of regulatory approval, agree to conduct research on newly marketed prescription drugs