30-day PMA supplement

It applies only to changes that FDA has identified as suitable for this route, so it cannot be chosen freely for any change. It is easy to confuse with the 30-day notice, which is a separate route for manufacturing changes under the same section of 21 CFR 814.

30-day PMA supplement means a supplemental application to an approved PMA in accordance with § 814.39(e).

21 CFR, 814.3