§814.46. Withdrawal of approval of a PMA. — Inbound Citations

(d) If FDA issues an order temporarily suspending approval of a PMA, the agency shall proceed expeditiously, but within 60 days, to hold a hearing on whether to permanently withdraw approval of the PMA in accordance with section 515(e)(1) of the act and the procedures set out in § 814.46.

(d) Before issuing an order withdrawing approval of an HDE, FDA will provide the applicant with notice and an opportunity for a hearing as required for PMA's under § 814.46(c) and (d), and will provide the public with notice in accordance with § 814.46(e), as applicable.

(d) Before issuing an order withdrawing approval of an HDE, FDA will provide the applicant with notice and an opportunity for a hearing as required for PMA's under § 814.46(c) and (d), and will provide the public with notice in accordance with § 814.46(e), as applicable.

(d) Before issuing an order withdrawing approval of an HDE, FDA will provide the applicant with notice and an opportunity for a hearing as required for PMA's under § 814.46(c) and (d), and will provide the public with notice in accordance with § 814.46(e), as applicable.