U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

All TitlesTitle 21Chapter IPart 814Subpart C - Subpart C—FDA Action on a PMA
§ 814.40 - Time frames for reviewing a PMA.
§ 814.42 - Filing a PMA.
§ 814.44 - Procedures for review of a PMA.
§ 814.45 - Denial of approval of a PMA.
§ 814.46 - Withdrawal of approval of a PMA.
§ 814.47 - Temporary suspension of approval of a PMA.
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