The association says FDA’s proposed approach could strengthen the role of consensus standards in medical device regulation, maintenance, and international harmonization.
The Association for the Advancement of Medical Instrumentation (AAMI) is supporting the US Food and Drug Administration’s proposed expansion of consensus standards use under the sixth Medical Device User Fee Amendments (MDUFA VI) agreement.
In public comments submitted to FDA, AAMI expressed support for provisions in the draft MDUFA VI commitment letter addressing consensus standards, conformity assessment, FDA reviewer training, and international regulatory harmonization.
MDUFA VI would cover fiscal years 2028 through 2032 and still requires congressional authorization.
Expanded Use of Consensus Standards
AAMI highlighted FDA’s inclusion of “enhanced use of consensus standards” as a priority under the proposed MDUFA VI commitments. The plans include further development of the Accreditation Scheme for Conformity Assessment (ASCA), additional FDA staff training on conformity assessments, and continued development of regulatory tools and standards designed for regulatory use.
According to AAMI, greater reliance on consensus standards could affect stakeholders across the industry. “HTM and sterile processing professionals will benefit from standards being embedded more deeply into how devices are actually regulated and maintained,” the association wrote.
AAMI also supported FDA’s proposal to expand the range of standards and device categories covered by ASCA and provide additional training for ASCA-accredited testing laboratories.
AAMI Calls for Continued FDA Participation
AAMI urged FDA to maintain its involvement in developing consensus standards, including a proposed commitment to attend industry meetings at least twice annually to discuss standards of mutual interest.
“Consistent FDA participation in the development of consensus standards helps to promote alignment between industry and regulators and ensure that standards are regulatory-ready and fit for conformity assessment purposes,” AAMI writes in the letter.
The association says FDA involvement could also support the development of US standards that feed into international standards work conducted through International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) technical committees.
AAMI additionally backed plans to evaluate and improve FDA reviewer training on the use of standards. The association says the commitment responds to member concerns about variability among reviewers and devices and the need for greater predictability in regulatory reviews.
Recommendations for MDUFA VI Implementation
While supporting the draft commitment letter, AAMI outlined several recommendations for implementing the standards-related provisions if MDUFA VI receives congressional authorization.
Among them, AAMI called for recurring, structured engagement between FDA and ANSI-accredited standards development organizations. The association also recommended that FDA work with standards organizations to establish criteria for determining when a standard is “regulatory-ready,” develop reviewer training, and identify existing FDA-recognized standards that could be more widely used in conformity assessment.
AAMI also urged FDA to base its proposed international coordinated-review pilot on standards already harmonized through ISO and IEC rather than developing separate technical requirements for the program.
The draft MDUFA VI commitments call for FDA to pilot a coordinated review pathway by the end of fiscal year 2028 for a device submitted with the same intended use to FDA and at least two other regulatory authorities.
AAMI says harmonized technical standards could provide the foundation needed to support that type of coordinated regulatory review.
ID 446728414 © BiancoBlue | Dreamstime.com
