AdvaMed Urges FDA to Narrow Guidance on Device QMS
Advanced Medical Technology Association (AdvaMed) is urging FDA to narrow and clarify a draft guidance on quality management system information, warning that the current proposal could add unnecessary burden and confusion to the premarket review process. In just-posted comments, the group said FDA’s recent draft guidance on Quality Management System Information for Certain Premarket Submission Reviews goes beyond what has historically been required for premarket approval and humanitarian device exemption applications by effectively pulling inspection-level records into static submissions.
“The draft guidance combines three distinct issues with their own regulatory frameworks — general QMS compliance, PMA and HDE submission content, and information FDA may use to assess compliance during review,” the group wrote. AdvaMed said that approach risks blurring the line between what manufacturers must submit in an application and what is more appropriately examined during inspections.
As an example, AdvaMed cited the draft guidance’s apparent expectation that companies submit detailed internal records, such as personnel training files and equipment validation records. The group said such “snapshot-in-time” documents are highly dynamic, can quickly become outdated during a lengthy review, and are better evaluated by investigators during pre-approval or routine inspections rather than by premarket reviewers.
AdvaMed also cautioned that the guidance could undermine FDA’s stated risk-based philosophy. The agency has previously said it will rely on tools such as past inspection history and audits under the Medical Device Single Audit Program to determine whether a pre-approval inspection is needed. AdvaMed urged FDA to expand, not dilute, that approach by allowing companies to submit additional QMS information voluntarily to support waiving or limiting inspections, rather than treating such information as mandatory.
The association further called on the agency to eliminate what it described as an implied requirement for “gap analyses” of legacy quality system documents created before the QMSR takes effect on 2/2. Because FDA has said the old and new regulations are “substantially similar,” AdvaMed argued that blanket retrospective analyses would be duplicative and resource-intensive, and should be reserved only for specific, high-risk issues identified during review.
Among other recommendations, AdvaMed asked FDA to clarify that the guidance applies only to original PMA and HDE applications — not supplements or annual reports — reduce duplicative information requests by allowing cross-referencing to existing forms and modules, and more clearly distinguish between quality system risk management and product safety risk management.
AdvaMed said refining the guidance in line with least-burdensome principles would help ensure that resources remain focused on evaluating device safety and effectiveness, while supporting a smoother transition to the new quality system framework and faster patient access to innovative medical technologies.