Freyr offers comprehensive FDA 21 CFR Part 820 compliance consulting for medical device manufacturers seeking to enter the United States (US) market. Our expert guidance covers all aspects of 21 CFR Part 820 requirements, from general provisions to specific controls for Class I, II, and III devices.

FDA 21 CFR Part 820 QSR – Overview

All domestic and foreign medical device manufacturers who intend to market their devices in the United States (US) must comply with the US Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) Part 820 Quality System Regulations (QSR), also known as Current Good Manufacturing Practices (CGMPs). Freyr offers FDA QSR consulting for medical device companies to help maintain proper FDA 21 CFR Part 820 compliance. The QSR for medical devices are defined in the FDA 21 CFR part 820 compliance requirements, which include:

  • General Provisions
  • Quality System Requirements (with respect to management responsibility, quality audits, and personnel)
  • Design Controls
  • Document Controls
  • Purchasing Controls
  • Identification and Traceability
  • Production and Process Controls
  • Acceptance Activities
  • Non-conforming Products
  • Corrective and Preventive Action (CAPA)
  • Labeling and Packaging Control
  • Handling, Storage, Distribution, and Installation
  • Record Management
  • Servicing
  • Statistical Techniques

The US FDA has defined a set of general and special controls to ensure that only safe and effective devices are marketed in the US. The general controls are related to adulteration or branding, device registration and listing, pre-market notification, records and reports, restricted devices, and Good Manufacturing Practices (GMP). These controls ensure consistency with the global quality system requirements. The requirements are related to the methods, facilities and controls used for designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices.

Class I Devices

The QSR for low-risk Class I medical devices are least stringent of all the three (03) device classes and should comply with the general controls. The US FDA must decide on the sufficiency of general controls to ensure the safety and efficacy of devices. Certain Class I devices are also exempted from GMP regulation, except for maintenance of general records and complaint files.

Class II Devices

The safety and efficacy of Class II medical devices cannot be established by general controls alone; rather, these devices also need to comply with special controls. These special controls are specific to a device category and include parameters like performance standards, market surveillance requirements, patient registries, special labeling requirements, and market data requirements. The US FDA has a set of special control guidelines available for various types of devices.

Class III Devices

The safety and efficacy of high-risk Class III devices cannot be established by general and special controls; they require the US FDA’s approval to be marketed in the US. The device manufacturer must submit an application for Pre-market Approval (PMA), which should include an onsite audit of the manufacturing facilities; only then will the US FDA grant approval.

GMP Exemption

Certain medical device categories listed under 21 CFR 862 to 892 are exempted from GMP requirements. However, the manufacturers of these GMP-exempted devices are required to maintain complaint files (21 CFR 820.198) and general records. Manufacturers of Investigational Device Exemption (IDE) are not exempted from the design control requirements outlined under 21 CFR 820.30.

FDA 21 CFR part 820 compliance includes the identification of applicable QSR for a given device or combination products and medical device compliance requires an expert to navigate through the complex QSR.

FDA 21 CFR Part 820 QSR

  • Classification of medical devices.
  • Identification of applicable quality controls.
  • Gap analysis of Quality Management System (QMS) documents.
  • Remediation plan for 21 CFR 820 compliance.
  • Mock audits of QMS.
  • Training on the US FDA QSR (FDA 21 CFR 820 compliance).
  • A dedicated Quality Assurance (QA) team of experts on medical devices.
  • Proven expertise in handling 21 CFR 820 compliance.
  • Flexible project delivery models.