The U.S. Food and Drug Administration (FDA) is preparing to implement a significant change in the regulation of medical devices, with its long-standing Quality System Regulation (QSR) set to be replaced by a new Quality Management System Regulation (QMSR) in February 2026. This transition is expected to have a substantial impact on developers of drug delivery devices.
Martin Murphy, Principal Consultant at 42 Technology, explained that this shift "represents a fundamental shift in how quality and safety are approached. More importantly, it offers an opportunity to align with global standards and embed risk-based thinking at the very core of development processes."
The QSR has guided FDA oversight for nearly three decades since its introduction in 1996. However, industry standards have evolved significantly during this time. The FDA’s move toward QMSR will bring its requirements closer to those found in ISO 13485:2016, an internationally recognized benchmark for medical device quality management systems.
Murphy noted that harmonizing with ISO 13485:2016 will reduce regulatory duplication and make compliance easier for companies operating in multiple countries. He also highlighted the importance of ISO 14971, which provides guidance on risk management throughout the lifecycle of medical devices.
A major difference between the outgoing QSR and incoming QMSR is the central role assigned to risk management. Under QSR, risk was minimally addressed, but QMSR incorporates it throughout all phases of product development and monitoring.
According to Murphy, "every stage of a product’s lifecycle, from design and development through to production, monitoring, and post-market surveillance, must explicitly incorporate risk management." For drug delivery device makers—whose products are often used in critical therapeutic settings—this approach can help ensure higher patient safety standards and potentially faster regulatory approvals.
Murphy outlined several implications for companies developing drug delivery devices:
- The alignment with international standards will reduce regulatory fragmentation.
- Risk considerations should be embedded from the earliest stages of design.
- Manufacturing must proactively mitigate potential failures before products reach patients.
- Ongoing monitoring after market launch will require real-world performance data to inform continuous improvement.
The FDA has not yet finalized updates to its inspection methods but is expected to focus more on risk management during future inspections. Murphy warned that companies delaying their preparations could face challenges once new inspection models are implemented.
He advised organizations to use this period as an opportunity: "Forward-thinking organisations should see this transition not as a compliance hurdle, but as an opportunity to strengthen their internal culture of quality and innovation." Recommended steps include benchmarking current systems against ISO 13485:2016, integrating ISO 14971-based risk management early in product development, training cross-functional teams on risk-first thinking, and staying ready for changes in FDA inspections.
Murphy concluded that “the transition to QMSR represents more than just a regulatory update; it reflects a maturing of the global medical device ecosystem.” He encouraged companies involved in drug delivery device development to act now so they can meet evolving expectations while delivering safer therapies worldwide.
"The FDA’s evolution from QSR to QMSR is not just about keeping pace with international standards; it’s about fostering a culture where risk management and quality are inseparable from innovation."
"By proactively adapting, drug delivery device developers can not only ensure compliance but also demonstrate leadership in delivering patient-centric solutions that meet the highest standards of global healthcare."
