FDA Strives to Harmonize 21 CFR Part 820 with ISO 13485:2016

Zuhal Reed, Esq. | Risk Management Senior Staff Attorney | Medmarc

February 28, 2022

The Food and Drug Administration (FDA) has continued to move towards harmonizing U.S. regulations with international standards for the regulation of medical devices. On February 23, 2022, FDA published its draft rule, “Medical Devices; Quality System Regulation Amendments,” in the Federal Register. Upon finalization of the new rule, the Quality System Regulation, or QSR, may be renamed the “Quality Management System Regulation,” or QMSR. This new rule strives to harmonize the current Good Manufacturing Practices found in 21 CFR Part 820 Quality System Regulation (QSR) with the international standards found in ISO 13485:2016.

This move by FDA, which will be the first major change to the QSR in over 20 years, will update the prior regulation. However, this effort to harmonize with international standards has been ongoing since 2018 and is in line with FDA’s more recent endeavor to align with international regulatory standards for drugs and devices. Traditionally, medical device manufacturers have relied on 21 CFR Part 820 to ensure compliance with regulatory standards for selling medical devices in the United States while maintaining a separate system for compliance with international standards. They will now be able to ensure compliance with all regulators – both international and domestic by relying on a single compliance and regulatory standard.  There will be some minor differences between the US standard and ISO 13485. Namely, the US standard will speak to records, device labeling, and packaging, because the international standard does not discuss labeling inspection requirements clearly.

By harmonizing these two standards, medical device manufacturers could save hundreds of millions of dollars in the long run[1]. They will also be able to decrease the burden of recordkeeping for two separate sets of regulations by maintaining records that reflect compliance with a single standard for device quality, recordkeeping, and processes. However in the short run, it is estimated that medical device companies are looking at millions of dollars[2] in cost to get in line with the new regulatory standards.

Upon finalization, this rule should go into effect one year from publication in the Federal Register. At that point, it would be prudent for medical device companies to consult with their legal teams to ensure compliance with the new regulations.


[1] https://www.medtechdive.com/news/fda-proposed-rule-quality-requirements-ISO-13485/619244/

[2] Ibid.

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