eCFR Reference Browser

---

title: "21 CFR §822.10"

source: "https://www.ecfr.gov/current/title-21/section-822.10"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "822"

part_subject: "POSTMARKET SURVEILLANCE"

subpart_code: "C"

subpart_subject: "Postmarket Surveillance Plan"

section_number: "822.10"

section_subject: "What must I include in my surveillance plan?"

cfr_reference: "21 CFR 822.10"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

§822.10 - What must I include in my surveillance plan?