21 CFR 820 Quality System Regulation for Devices

What is 21 CFR Part 820?

FDA 21 CFR Part 820, also known as the Quality System Regulation QSR outlines Current Good Manufacturing Practice (cGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. These requirements are meant to ensure that medical devices are safe and effective.

The Part 820 regulation is closely tied to the ISO 13485 standard for Medical Devices, with very few differences between the two.

The sections of the 21 CFR Part 820 regulation:

  • Subpart A – General Provisions
  • Subpart B – Quality System Requirements
  • Subpart C – Design Controls
  • Subpart D – Document Controls
  • Subpart E – Purchasing Controls
  • Subpart F – Identification & Traceability
  • Subpart G – Production & Process Controls
  • Subpart H – Acceptance Activities
  • Subpart I – Nonconforming Product
  • Subpart J – Corrective & Preventive Action
  • Subpart K – Labeling & Packaging Control
  • Subpart L – Handling, Storage, Dist & Inst.
  • Subpart M – Records
  • Subpart N – Servicing
  • Subpart O – Statistical Techniques

What type of Businesses comply to Part 820?

Certification to Part 820 is not performed. Instead, businesses comply with the standard to ensure safe and quality product, and to show due diligence to the US FDA.

Typical businesses that comply to the standard are as follows:

  • Suppliers to medical device manufacturers
  • Finished medical device manufacturers
  • Distributors to medical device manufacturers.

What type of Auditing does Part 820 require?

The 21 CFR Part 820 standard requires auditing to verify the effectiveness of the quality system. The auditing must be performed by properly trained individuals that are impartial or un-biased against the areas they are auditing. Additionally, the regulation requires that follow-up on deficient items be performed to ensure adequate remediations. Excerpts from the 820.22 Quality Audit section of the standard are listed below:

“Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.”

“Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented.”