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21 CFR Part 820 · Quality Management System Regulation

§ 820.50 Purchasing controls

Subpart E - Purchasing Controls Official text on eCFR
Removed from 21 CFR. The Quality Management System Regulation (QMSR) replaced the Quality System Regulation on 2 Feb 2026. Purchasing controls now sit in § 820.10 through ISO 13485:2016 clause 7.4. See § 820.10. The text below is the former QSR wording, kept for reference.

Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

(a) Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall:

(1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.

(2) Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.

(3) Establish and maintain records of acceptable suppliers, contractors, and consultants.

(b) Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device. Purchasing data shall be approved in accordance with § 820.40. Subpart F—Identification and Traceability

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 § 820.50

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

  • Purchasing controls, Lack of or inadequate procedures 1,628
  • Evaluation of suppliers, contractors, etc., requirements 395
  • Acceptable supplier records, inadequate records 242
  • Documented evaluation 229
  • Supplier oversight 215
  • Supplier notification of changes 185

Warning letters citing § 820.50

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

FDA guidance that cites § 820.50

and 2 more.