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US FDA
QSR Amendments : Relevance to Medical Device Component
Manufacturers
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Mr. Bhupesh Sood
CEO, SEC Global, Ahmedabad |
Excerpts of Medical Devices;
Quality System Regulation Amendments – Special
reference to component manufacturers. The following
points must be considered for future compliance
requirements:-
1. The Food and Drug Administration
(FDA, the Agency, or we) is issuing a final rule to
amend the device current good manufacturing practice (CGMP)
requirements of the Quality System (QS) regulation to
harmonize and modernize the regulation.
2. DATES - This rule is effective
February 2, 2026.
3. FDA is revising its medical
device CGMP requirements as set forth in the QS
regulation, codified in part 820 (21 CFR part 820).
FDA is accomplishing this primarily by incorporating
by reference the 2016 edition of ISO 13485 (ISO
13485). Through this rulemaking, FDA is harmonizing
quality management system requirements for medical
devices with requirements used by other regulatory
authorities. |
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DEPARTMENT OF HEALTH
AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 4 and 820
[Docket No. FDA–2021–N–0507]
RIN 0910–AH99
Medical Devices; Quality System Regulation Amendments
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
I. Executive Summary
A. Purpose of the Final Rule
FDA has historically
recognized the benefits of harmonization with other
regulatory authorities and, over time, has taken a
number of actions to promote consistency with its
regulatory counterparts. As part of such activities,
FDA is revising its medical device CGMP requirements
as set forth in the QS regulation, codified in part
820 (21 CFR part 820). FDA is accomplishing this
primarily by incorporating by reference the 2016
edition of ISO 13485 (ISO 13485). Through this
rulemaking, FDA is harmonizing quality management
system requirements for medical devices with
requirements used by other regulatory authorities.
B. Summary of the
Major Provisions of the Final Rule
We are amending part 820,
primarily through incorporating by reference the
quality management system requirements of ISO 13485.1
We have determined that the requirements in ISO 13485
are, when taken in totality, substantially similar to
the requirements of the QS regulation, providing a
similar level of assurance in a firm’s quality
management system and ability to consistently
manufacture devices that are safe and effective and
otherwise in compliance with the Federal Food, Drug,
and Cosmetic Act (FD&C Act). As such, we are retaining
the scope of the QS regulation, and amending many of
the provisions. We are also amending the title of the
regulation and establishing additional requirements
and provisions that clarify certain expectations and
certain concepts used in ISO 13485. These additions
ensure that the incorporation by reference of ISO
13485 does not create inconsistencies with other
applicable FDA requirements. This revised part 820 is
referred to as the Quality Management System
Regulation (QMSR). FDA has made conforming edits to
part 4 (21 CFR part 4) to clarify the device Quality
Management System (QMS) requirements for combination
products. These edits do not impact the CGMP
requirements for combination products.
C. Legal Authority
We are issuing this rule
under the same authority that FDA initially invoked to
issue the QS regulation and combination product
regulations, as well as the general administrative
provisions of the FD&C Act: 21 U.S.C. 351, 352, 353,
360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371,
374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.
D. Costs and Benefits
We estimate that the QMSR
will result in an annualized net cost savings
(benefits) of approximately $532 million at a 7
percent discount rate (cost savings: $540M, costs:
$8.2M) and approximately $554 million in annualized
net cost savings at a 3 percent discount rate (cost
savings: $561M, costs: $7.29M). In addition to the
cost savings to the medical device industry, the
qualitative benefits of the rule include quicker
access to newly developed medical devices for patients
leading to improved quality of life of the consumers.
The rule will also align part 820 with other related
programs potentially contributing to additional cost
savings.
(Ref:
https://www.govinfo.gov/content/pkg/FR-2024-02-02/html/2024-01709.htm
) |
4. FDA has not undertaken a significant
revision of part 820 since the 1996 Final Rule.
5. We are amending part 820, primarily
to incorporate by reference ISO 13485, Medical
Devices—Quality Management System Requirements for
Regulatory Purposes. This resulting regulation is referred
to as the QMSR.
6. Scope - FDA has chosen, in this
regulation, not to require components and parts to comply
with the requirements of this rule making. FDA’s
determination not to extend this regulation to
manufacturers of components and parts does not preclude
any contract between manufacturers that requires
compliance with this rulemaking and is consistent with
Clause 0.1 of ISO 13485.
7. FDA agrees that manufacturers of
components or parts of finished devices are not subject to
the QMSR. We also note that, although the scope of the
QMSR remains unchanged, FDA has the legal authority to
inspect component manufacturers under the FD&C Act should
the need arise.
8. FDA encourages manufacturers to
consider provisions of this regulation as appropriate. FDA
declines to specify in this rulemaking the specific
provisions ‘‘appropriate for’’ manufacturers of components
or parts of finished device.
9. Voluntary compliance with the QMSR
will provide manufacturers of components or parts of
finished devices a framework for achieving quality
throughout the organization.
10. FDA notes that because ISO 13485
clarifies the term ‘‘as appropriate’’ in section 0.2,
‘‘Clarification of concepts,’’ in the manner requested by
the commenter, we do not need to add such a definition to
this rule.
11. FDA confirms that compliance only
with ISO 13485 does not fully satisfy the QMSR. With the
incorporation of ISO 13485 in the QMSR, the requirements
of ISO 13485 become the foundational requirements for
device CGMPs. FDA has added limited additional
requirements to the QMSR where appropriate, and thus
device manufacturers must meet those additional QMSR
requirements in addition to those set forth in ISO 13485.
12. This final rule incorporates the
entire introduction from ISO 13485, which sets forth
important concepts. FDA confirms that the QMSR
incorporates ISO 13485:2016 by reference, including
Clauses 0.1 (General), 0.2 (Clarification of Concepts),
and 0.4 (Relationship with ISO 9001) of the Introduction
of the standard. |
