FDA Will Transition from 21 CFR 820 QSR to ISO 13485:2016 for Medical Device Quality Systems Audit Inspections in the Near Future


FDA has formally announced its intention to transition away from the Quality Systems Regulation (QSR) per 21 CFR 820 and transition to the ISO 13485:2016 for its audit inspections of medical device manufacturers. The new rule could be released as soon as mid 2019 and will roll out over the next few years. Industry should begin to perform any relevant gap analyses to prepare for the transition.

The agency states: "FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation."

FDA also said: "We recognize there will be a significant impact on FDA for implementation. For example: - Training on ISO 13485 requirements, interpretation, best practices, etc. to CDRH staff and ORA investigators and compliance officers - Changes to the inspection model (QSIT) - Revisions/updates to numerous documents - Changes to IT systems. Transition period will likely be a few years"

They continue: "FDA is currently working on the proposed rule which will be issued in 2019 - A panel committee meeting will be held after issuance of the proposed rule."

For medical device companies commercializing their products in the United States, there are implications in preparing for and adapting to the FDA's paradigm shift away from 21 CFR 820 to the ISO 13485:2016 Standard for "Medical devices -- Quality management systems -- Requirements for regulatory purposes".

The transition is imminent, and may be of particular concern for medical device companies commercializing in the United States that have never been certified to the ISO 13485 standard. 

In line with recent applicable changes to regulatory requirements including the coming into force of ISO 13485:2016, MDSAP, and the EU MDR 2017/45, this change in the FDA requirements adds to the current regulatory burden on the medical device industry, but is not insurmountable, so long as companies allow sufficient lead time and gap analyses or internal audits to make adjustments.

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Source: Publication from FDA on the FDA's intent to transition to the ISO 13485:2016 and away from the 21 CFR 820 Quality System Regulation can be found on the FDA Website  here .

Thomas Regulatory Resolutions (TRR) is a consulting firm providing services to the medical device industry and has the depth of experience and certified lead auditors per ISO 13485:2016 and can assist your medical device company in a confidential gap analysis or internal audit to the ISO 13485:2016 to prepare you for your transition from the 21 CFR 820 QSIT Model to the ISO 13485:2016. TRR has transitioned and sustained a variety of client medical device companies to the ISO 13485:2016 as well as to the Medical Device Single Audit Program (MDSAP) per the applicable regulatory requirements and also assisting with the transition to the EU MDR 2017/745 along with other audit needs such as supplier audits, ongoing internal audits, defending your company during audits by external regulatory agencies, and remediation of regulatory agency findings and responding to regulatory agencies, as well as regulatory submissions (i.e. 510(k), EU Technical Files, and global international regulatory submissions for market clearance. For our full scope of services please see our brochure here.

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