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

Requires user facilities, importers, and manufacturers to maintain written MDR procedures covering event identification and evaluation, standardized reportability decisions, timely report submission, and records of evaluations, reports, annual report data, and FDA-accessible information.

Part 803, Medical Device Reporting · Subpart A, General Provisions

How FDA words it

The opening lines investigators use most when they cite 803.17, from the 483s we hold.

Written MDR procedures have not been developed.Most used

Written MDR procedures have not been developed, maintained and implemented.

Written MDR procedures have not been implemented.

Cited over time

483s citing 803.17, by year

Most citations in 2019. Bars are relative to the busiest year. *2026 to date.

Recent 483s citing 803.17

See all 483s citing 803.17

The regulation text

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

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.

Questions

What does 21 CFR 803.17 require?

How do FDA investigators word a 803.17 observation?

The most common opening is: “Written MDR procedures have not been developed.”

Which sections are cited alongside 803.17?

In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.198 (Complaint files), 820.30 (Design controls), 820.50 (Purchasing controls).