C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 822—POSTMARKET SURVEILLANCE › Subpart C—Postmarket Surveillance Plan

21 C.F.R. § 822.10

What must I include in my surveillance plan?

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Your surveillance plan must include a discussion of:

(a) The plan objective(s) addressing the surveillance question(s) identified in our order;

(b) The subject of the study, e.g., patients, the device, animals;

(c) The variables and endpoints that will be used to answer the surveillance question, e.g., clinical parameters or outcomes;

(d) The surveillance approach or methodology to be used;

(e) Sample size and units of observation;

(f) The investigator agreement, if applicable;

(g) Sources of data, e.g., hospital records;

(h) The data collection plan and forms;

(i) The consent document, if applicable;

(j) Institutional Review Board information, if applicable;

(k) The patient followup plan, if applicable;

(l) The procedures for monitoring conduct and progress of the surveillance;

(m) An estimate of the duration of surveillance;

(n) All data analyses and statistical tests planned;

(o) The content and timing of reports.

Notes of Decisions
Cited in 3 cases, 2018–2019 · leading case: Wang Yan v. Rewalk Robotics Ltd., 391 F. Supp. 3d 150 (D.D.C. 2019).
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Wang Yan v. Rewalk Robotics Ltd., 391 F. Supp. 3d 150 (D.D.C. 2019). “21 C.F.R. 822.10. The FDA required the study due to concerns that a malfunction could result in serious injury or death to a patient.”
Wang Yan v. ReWalk Robotics Ltd. (D. Mass. 2018). “21 C.F.R. 822.10. The FDA required the study due to concerns that a malfunction could result in serious injury or death.”
Wang Yan v. ReWalk Robotics Ltd. (D. Mass. 2019). “21 C.F.R. 822.10. The FDA required the study due to concerns that a malfunction could result in serious injury or death to a patient.”
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