Life Sciences Horizons Brochure 2025 - Flipbook - Page 95
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2025 Horizons Life Sciences and Health Care
FDA transition to QMSR marks a new era in device compliance
FDA has taken a significant step forward in
modernizing its regulatory framework with the
transition to the Quality Management System
Regulation (QMSR), which essentially aligns FDA's
regulatory requirements for medical devices with the
internationally recognized ISO13485:2016 standard.
By adopting this harmonized approach, FDA aims to
streamline compliance, reduce regulatory burdens,
and enhance global trade and innovation.
One of the most significant shifts is the harmonization with
ISO13485:2016, which will make it easier for manufacturers to
comply with both U.S. and international requirements, reducing
duplicative efforts, particularly for companies that already follow
ISO13485. Another crucial change is the adoption of a risk-based
approach to quality management. The QMSR emphasizes
identifying and mitigating risks throughout a product's life
cycle, ensuring patient safety and product reliability.
Supplier controls have also been enhanced under the QMSR,
which places greater emphasis on robust supplier management
and risk-based strategies to ensure product quality. Manufacturers
are now required to implement stronger oversight mechanisms,
ensuring that their suppliers meet the necessary regulatory
standards. Additionally, the transition to QMSR streamlines
documentation and reporting requirements. The aim is to
reduce unnecessary paperwork while maintaining strong
regulatory oversight.
While FDA's transition to the QMSR aligns closely with ISO13485,
some key differences will remain, requiring companies to manage
both sets of requirements carefully. One major distinction is
regulatory oversight, as FDA will continue to enforce specific legal
obligations beyond ISO13485, including compliance with the
FDCA and Unique Device Identification (UDI) requirements.
Additionally, complaint handling and reporting requirements
under the QMSR remain stricter, particularly in areas like Medical
Device Reporting (MDR), which demands more rigorous adverse
event tracking than ISO13485’s general guidelines. FDA will also
maintain its independent inspection process, which differs from
the third-party certification audits used for ISO13485 compliance.
Documentation requirements will continue to diverge as well,
with FDA mandating additional records such as the Quality
System Record (QSR), such as device history records (DHRs),
device master records (DMRs), and quality system procedures.
Another key change in the transition to the QMSR is that FDA will
have greater visibility into certain quality records. Under the QSR,
FDA’s policy is that it will not routinely inspect internal audit
reports, Management Review materials, or supplier audits. This
policy has been used to ensure the integrity of those processes so
that companies can challenge their systems without the risk of an
FDA investigator reviewing the materials. Under the QMSR, these
materials will now be subject to review during an inspection
or audit.
FDA's QMSR is set to become effective on 2 February 2026,
following a one-year transition period after its final rule was
published in February 2024. This gives medical device
manufacturers time to adjust their quality management systems
to comply with the new requirements. Industry experts and
stakeholders have generally welcomed the change, viewing it as a
positive step toward regulatory modernization and efficiency. As
the industry moves forward, the harmonization with ISO 13485 is
expected to drive innovation, efficiency, and improved health care
outcomes worldwide.
Jodi Scott
Partner
Denver
Michael Heyl
Partner
Washington, D.C.
