Devices

Prepare Now for QMSR Transition: Attorneys

Four Hogan Lovells attorneys say medical device companies should begin performing gap assessments of their quality systems now to assure compliance with the 2/2/2026 compliance date for the new FDA Quality Management System Regulation (QMSR). Writing in an online post, the attorneys say the agency originally intended to give a one-year transition period and extended it to two years based on comments received on its draft rule.

“This timeline will pose particular challenges for companies who are building new systems, submitting premarket approval applications that require detailed manufacturing sections, and re-engineering existing systems to meet the new requirements on the effective date, but must continue to operate under the Quality System Regulation (QSR) until then,” the post says. “Careful and detailed planning will be necessary to ensure compliance today and when the QMSR becomes effective.”

The attorneys write that FDA will use the transition time to engage in various implementation activities, updating information technology systems, training agency staff responsible for assessing compliance with medical device QMSR requirements, developing an inspection process, and revising relevant regulations, guidance documents, and other documents affected by the rulemaking.

“One potential challenge will be how the agency handles PMA applications during the transition period,” the attorneys write…. “It is unclear how FDA will handle PMA manufacturing sections and inspections for PMAs submitted prior to 2/2026 and approved after this date. For example, it is unclear whether a PMA applicant will need to submit a PMA amendment prior to approval to reflect transition of their QMS (quality management system) from the QSR to the QMSR. Moreover, if a pre-approval inspection is conducted after the QMSR becomes effective, it is unclear whether the standard applied during the inspection will be to the QMSR or to the quality system described in the PMA manufacturing section that ostensibly complies with the QSR. For Class 3 products already on the market, it also is unclear whether conversion to the QMSR triggers the need for a PMA supplement.”

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