Expert: Prof. Dr. Christian Johner
In 21 CFR part 820, the FDA formulates the requirements for the quality management systems of medical device manufacturers, among others. Thus, 21 CFR part 820 (Quality System Regulation QSR) is or was the counterpart to ISO 13485.
With this change, the previous requirements for a design history file, a device master record, and a device history record are no longer explicitly mentioned. Nevertheless, ISO 13485 also requires similar records.
The Office of Management and Budget has determined the effective date of this change to be December 2023.
The Quality System Regulations consist (before referencing) of Subparts A through O, which include Sections 1 through 250 (see Tab. 1 and Fig. 2).
Part 820 requires a complete quality management system, which requires that the “standard” operating procedures must be documented and implemented. These include:
Depending on the class of the medical device, the manufacturers must comply with the General Controls (§ 501 ff) laid down in the "Food, Drug & Cosmetic Act" and, from class II, also with the "Special Controls." The "General Controls" already include "Good manufacturing practice requirements" that relate to the design, production, packaging, storage, and installation of the devices.
It is precisely these requirements for "Current good manufacturing practice (CGMP)" that are the subject of the Quality System Regulation QSR. Thus, these regulations must be complied with by all medical device manufacturers and also other players such as contract manufacturers. Only a few class I devices are exempt or GMP-exempt. The FDA reviews compliance with CGMP by inspection.
Area 820.30, with the design controls, is particularly relevant for the development department. This even applies to the development of class I medical devices if they contain software or are software.
The requirements of 820.30 are very general. For this reason, manufacturers of medical devices that contain software, for example, are also guided by the FDA's guidance documents. These describe in detail how, for example, the design input must be documented.
Many manufacturers underestimate the importance of the Design History File DHF (820.30 j). This set of documents must make it possible to prove that the procedures described in 21 CFR part 820 were actually implemented and that the documentation was not created retrospectively.
AnsonGroup has published a comparison of the requirements of ISO 13485 and FDA QSR. The extensive correspondence between the two standards is obvious. Nevertheless, there are differences between ISO 13485 and part 820 to consider:
The FDA does not recognize ISO 13485 certification as proof of conformity with the requirements of 21 CFR part 820. In contrast to ISO 13485, there is also no certification according to 21 CFR part 820.
Even before the harmonization of QSRs with ISO 13485, manufacturers can simultaneously demonstrate compliance with the requirements of 21 CFR part 820 and ISO 13485:2016 as part of the Medical Device Single Audit Program MDSAP.
It is a great step forward for the harmonization of regulatory requirements that the FDA essentially replaces its requirements for a QM system in 21 CFR part 820 with reference to ISO 13485. It explains in the "new" 21 CFR part 820 how certain requirements, e.g., for product identification and vigilance, are to be met in concrete terms.
It would have served medical device manufacturers if the MDR and IVDR had also followed this path.
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