All domestic and foreign medical device manufacturers intending to market the devices in the USA shall comply with the US FDA’s Quality System Regulations (QSR), which are also known as Current Good Manufacturing Practices (CGMPs). The quality system regulations for the medical devices are defined in the FDA 21 CFR part 820 compliance requirements, which details -
- General Provisions
- Quality System Requirements with respect to Management responsibility, quality audit and personnel
- Design Controls
- Document Controls
- Purchasing Controls
- Identification and Traceability
- Production and Process Controls
- Acceptance Activities
- Non-Conforming Product
- Corrective and Preventive Action (CAPA)
- Labeling and Packaging Control
- Handling, Storage, Distribution and Installation
- Record Management
- Statistical Techniques
The US FDA has defined a set of general controls and special controls to ensure that only safe and effective devices are marketed in the USA. The general controls are related to adulteration or branding, device registration and listing, premarket notification, records and reports, restricted devices and good manufacturing practices. These controls help in achieving 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 regulations 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 general recording and maintenance of complaint files.
Class II Devices
The safety and effectiveness of Class II medical devices cannot be established by general controls alone and shall comply with special controls. These special controls are specific to a device category and include performance standards, market surveillance requirements, patient registries, special labeling requirements and market data requirements defined. The FDA has a special control guideline available for various devices.
Class III Devices
The safety and effectiveness of high-risk Class III devices cannot be established by general and special controls and require the US FDA’s approval to market the devices in the USA. The device manufacturer shall submit an application for Pre-Market Approval (PMA), which would include onsite audit of the manufacturing facilities before an approval is granted by the US FDA.
Certain device categories listed in 21 CFR 862 to 892 are exempted from GMP requirements. However, the manufacturers of these GMP exempted medical devices are required to maintain compliant files (21 CFR 820.198) and general requirements of records. The 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 identification of applicable quality system regulations for the given device or combination products and the medical device compliance requires an expert to navigate through the complex Quality System Regulations.
- Classification of medical devices
- Identification of applicable quality controls
- Gap analysis of quality management system documents
- Remediation plan for 21 CFR 820 compliance
- Mock audits of quality management systems
- Training on the US FDA Quality System Regulations (21 CFR 820 compliance)
- Dedicated Quality Assurance team of experts for medical devices
- Proven expertise in handling 21 CFR 820 compliance
- Flexible project delivery models