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21 CFR Part 803 · Medical Device Reporting

§ 803.17 What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?

Subpart A - General Provisions Official text on eCFR Amendment history

If you are a user facility, importer, or manufacturer, you must develop, maintain, and implement written MDR procedures for the following:

(a) Internal systems that provide for:

(1) Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements;

(2) A standardized review process or procedure for determining when an event meets the criteria for reporting under this part; and

(3) Timely transmission of complete medical device reports to manufacturers or to us, or to both if required.

(b) Documentation and recordkeeping requirements for:

(1) Information that was evaluated to determine if an event was reportable;

(2) All medical device reports and information submitted to manufacturers and/or us;

(3) Any information that was evaluated for the purpose of preparing the submission of annual reports; and

(4) Systems that ensure access to information that facilitates timely followup and inspection by us.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 803.17

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Devices).

  • Lack of Written MDR Procedures 1,697
  • Lack of System for Event Evaluations 225
  • Lack of System for Determining MDR Events 149
  • Lack of System for Timely Submission of Reports 90
  • Info evaluated to determine if event was reportable 58
  • Reports and information documentation 21

Warning letters citing § 803.17

102 FDA warning letters since 2017 cite this section ; the most recent:

FDA guidance that cites § 803.17

Amendment history

Federal Register documents that created or amended this section.