Federal Registerには、以下のとおり記載されています。

これらは、2月2日までにQMSRに切り替えても構わないが、FDAによる査察はQSRで実施される、という意味でしょうか。

若しくは、2026年2月1日まではQSRを遵守しなければならず、2月2日から一斉にQMSRに従った手順（QMS）を施行しなさい、という意味でしょうか。

Medical Devices; Quality System Regulation Amendments

1. Effective Date and Implementation Strategy
2. Effective Date

(Comment 77) Some comments recommended that FDA phase in an effective date. Comments suggest that FDA either implement the effective date in phases, or allow firms to comply with either the QS regulation requirements or the requirements described in this QMSR rulemaking for a period of time following publication in the Federal Register . Another comment suggests that FDA use a risk-based approach to transition to the QMSR, taking into account the class of medical device.

(Response) FDA disagrees that a phased-in effective date is appropriate, because having two inspectional programs in operation at the same time would be inefficient and would result in significant potential for confusion. FDA believes that the 2-year effective date provides sufficient time to implement the QMSR, and that it meets FDA's goals of efficiently achieving global harmonization, streamlining regulatory requirements, reducing burdens on regulated industry, and providing patients more efficient access to necessary devices. FDA recognizes that it is important for manufacturers to prepare to align their practices with the QMSR as soon as practical, and some manufacturers may choose to begin complying with the QMSR before the effective date. However, FDA does not intend to require compliance with the QMSR until its effective date. Until then, manufacturers are required to comply with the QS regulation. FDA's inspections are risk based and will continue to be consistent with section 510(h) of the FD&C Act.