21 CFR 820

The criteria of the Quality System Regulation (QRS) are in place to guarantee that medical devices are of high quality, safe, and effective. The current good manufacturing practice (CGMP) rules for producing medical devices are outlined in 21 CFR Part 820. It regulates the techniques, equipment, and controls used in the design, production, packing, labelling, storage, installation, and service of medical devices.

The first CGMP standards for medical devices were developed on July 21, 1978, and the regulation was codified under part 820 on December 18, 1978. The FDA began revising the CGMP in 1990 to include design controls.

The FDA 21 CFR 820 regulations apply to completed device manufacturers that sell commercial medical devices. A completed device is defined as “any device or accessory to any device that is acceptable for use or capable of functioning, regardless of whether it is packed, labelled, or sterilised,” according to 21 CFR 820.3(l).

21 CFR 820 IMPLEMENTATION FOR SUCCESSFUL FDA INSPECTION

FDA inspects (Quality System Inspection Technique (QSIT)) medical device producers registered facilities on a regular basis to ensure that internal quality procedures and systems are in compliance with or in violation of 21 CFR 820 standards. The FDA will issue a form 483 Inspectional Observations if any infractions are identified. We’ve discovered that manufacturers that don’t precisely follow the provisions below end up receiving 483s.

  • Subpart A – General Provisions (§§ 820.1 – 820.5)

  • Subpart B – Quality System Requirements (§§ 820.20 – 820.25)

  • Subpart C – Design Controls (§ 820.30)

  • Subpart D – Document Controls (§ 820.40)

  • Subpart E – Purchasing Controls (§ 820.50)

  • Subpart F – Identification and Traceability (§§ 820.60 – 820.65)

  • Subpart G – Production and Process Controls (§§ 820.70 – 820.75)

  • Subpart H – Acceptance Activities (§§ 820.80 – 820.86)

  • Subpart I – Nonconforming Product (§ 820.90)

  • Subpart J – Corrective and Preventive Action (§ 820.100)

  • Subpart K – Labeling and Packaging Control (§§ 820.120 – 820.130)

  • Subpart L – Handling, Storage, Distribution, and Installation (§§ 820.140 – 820.170)

  • Subpart M – Records (§§ 820.180 – 820.198)

  • Subpart N – Servicing (§ 820.200)

  • Subpart O – Statistical Techniques (§ 820.250)

For more details refer to the FDA website

BENEFITS OF 21 CFR 820 IMPLEMENTATION

  • Improved Document Control

  • Effective Audit Management

  • Better Employee Training Programs

  • Better Risk Management

  • Efficient Tracking and Reporting

  • Improved Supplier Quality

  • Robust CAPA Processes

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