FDA 21 CFR PART 820

1. FDA 21 CFR PART 820 All the manufacturers supplying medical devices to the U.S. are required to maintain a quality management systemin compliance with the FDA 21 CFR Part 820. This quality system regulation focuses on current good manufacturing processes and controls used for the design, manufacture, packaging, labelling, storage, installation, servicing for all the medical devices. 21 CFR Part 820 lays out the essential elements that a quality system shall embody, without describing specific ways to establish them, as the requirements must apply to a broad spectrum of medical devices. Thus, the manufacturer must develop a quality system that commensurate with the risk presented by their device, complexity of the device and manufacturing process, extent of the activities to be carried out and size and complexity of the manufacturer. The medical device manufacturers undergo USFDA inspections, to ensure compliance to 21 CFR Part 820, however, there is no certification method for Part 820 and solely compliance with the requirements is assessed. Maintaining an effective quality management system permits the medical device manufacturers to ensure a smooth FDA audit. Quality management system constitutes the requirements or controls for the subsystems such as management, design, document, record, purchasing, labelling and packaging, identification and traceability, corrective and preventive actions, production and process, equipment, facility, servicing, statistical techniques, etc. A major portion of FDA 21 CFR Part 820 regulation requirements was incorporated in ISO 13485 in its 2016 revision, which also contained several requirements that do not exist in 21 CFR 820. Thus, the organisations conforming to ISO 13485: 2016 can move confidently towards compliance of 21 CFR Part 820 (Quality System Regulation). There are few additional requirements to be considered while complying to 21 CFR, for example, part 810, which deals with medical device recall procedures and part 830, dealing with a unique device identification of the medical devices. FDA announced a new proposed rule ‘Harmonizing and modernizing regulation of medical device quality systems’ in spring 2018, with intent to modernize and reduce compliance and record keeping burdens on device manufacturers by harmonising the quality system regulations (21 CFR Part 820) to ISO 13485: 2016. Thus, for the medical device manufacturers aiming to commercialise their products in the U.S., there are implication in preparing for and adapting to the FDA’s shift to ISO 13485: 2016 standard. The transition is forthcoming and may pose a new challenge for the manufacturers who only comply with the FDA’s quality system requirements and not ISO 13485: 2016, in terms of work and investment to meet the new requirements.