美国医疗器械法规CFR-2021-title21-vol8-part801.docx

Pt. 801 21 CFR Ch. I (4–1–21 Edition) (iii) of this section, FDA will render a decision within 45 days of the request for supervisory review. (ii) A person requesting supervisory review under paragraph (b)(1)(i) may request an in-person meeting or tele- conference with the supervisor review- ing the request for supervisory review. Except as provided in paragraph (b)(1)(iii) of this section, if a request for in-person meeting or teleconference is included in the request for super- visory review to CDRH, CDRH will schedule the meeting or teleconference to occur within 30 days of receipt of the request. Except as provided in para- graph (b)(1)(iii) of this section, a deci- sion will be rendered within 30 days of such meeting or teleconference. (iii) The timeframes for CDRH to render a decision provided in (b)(1)(i) and (ii) of this section, and the time- frame to schedule an in-person meeting or teleconference review in (b)(1)(ii) of this section, do not apply if a matter related to the 517A decision under re- view is referred by CDRH to external experts, such as an advisory com- mittee, as provided in §10.75(b) of this chapter. (2) Supervisory review. An initial or sequential request for supervisory re- view within CDRH under § 10.75 of this chapter of a decision other than a 517A decision that is not received by CDRH within 60 days after the date of the de- cision involved will be denied as un- timely, unless CDRH, for good cause, permits the request to be filed after 60 days. An initial or sequential request for supervisory review within CDRH of a decision other than a 517A decision must be addressed to the next organi- zational level or higher above the indi- vidual who made the decision; sub- mitted in electronic format in accord- ance with section 745A(b) of the Fed- eral Food, Drug, and Cosmetic Act, when applicable; marked, ‘‘Appeal: Re- quest for Supervisory Review’’ in the subject line of the electronic request; and sent to the CDRH Ombudsman at CDRHOmbuds