21 C.F.R. § 822.8 When, where, and how must I submit my postmarket surveillance plan?
Title 21 - Food and Drugs
You must submit your plan to conduct postmarket surveillance within 30 days of the date you receive the postmarket surveillance order. For devices regulated by the Center for Biologics Evaluation and Research, send three copies of your submission to the Document Control Center (HFM–99), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. For devices regulated by the Center for Drug Evaluation and Research, send three copies of your submission to the Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901–B Ammendale Rd., Beltsville, MD 20705–1266. When we receive your original submission, we will send you an acknowledgment letter identifying the unique document number assigned to your submission. You must use this number in any correspondence related to this submission. [67 FR 38887, June 6, 2002, as amended at 70 FR 14986, Mar. 24, 2005]
Title 21: Food and Drugs
PART 822—POSTMARKET SURVEILLANCE
Subpart C—Postmarket Surveillance Plan
§ 822.8 When, where, and how must I submit my postmarket surveillance plan?
