Subpart 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.