eCFR Reference Browser

---

title: "21 CFR §822.38"

source: "https://www.ecfr.gov/current/title-21/section-822.38"

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: "G"

subpart_subject: "Records and Reports"

section_number: "822.38"

section_subject: "What reports must I submit to you?"

cfr_reference: "21 CFR 822.38"

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"

---

You must submit interim and final reports as specified in your approved postmarket surveillance plan. In addition, we may ask you to submit additional information when we believe that the information is necessary for the protection of the public health and implementation of the act. We will also state the reason or purpose for the request and how we will use the information.

§822.38 - What reports must I submit to you?