As part of its required series of guidances on using real-world evidence, the U.S. FDA released a draft guidance in response to sponsors’ growing interest in the potential use of observational studies to contribute to a demonstration of the effectiveness or safety of a drug or biologic.
The U.S. FDA’s December 2023 draft guidance for the use of real-world evidence (RWE) for medical devices drew comment from across the spectrum of stakeholders, but industry is demonstrably wary of the draft on several points. The Medical Device Manufacturers Association (MDMA) offered several pointed criticisms, including that the draft seems to suggest that a fit-for-purpose study might be nearly indistinguishable from a conventional clinical trial, which MDMA said violates the least burdensome principle.
The U.S. FDA’s latest draft guidance for the use of real-world evidence (RWE) is a substantially heftier document than the 2017 final guidance that will shortly become obsolete, and buried in all those extra pages are a few key details.
The fifth medical device user fee agreement (MDUFA V) is a generous bump in monies for the U.S. FDA, some of which will go toward advancing the use of real-world evidence (RWE) in the agency’s regulatory decisions. The FDA just opened a docket for comment on how those monies might be doled out to entities other than the Medical Device Innovation Consortium (MDIC), an expansion that might nudge the regulatory science along a little more quickly and thus enhance the use of RWE for premarket submissions.
The Medical Device Innovation Consortium (MDIC) ran a series of 14 test cases to evaluate the value of real-world evidence (RWE) for regulatory decision making, but there were several sources of drag in this first phase of the project, such as a lack of availability of unique device identifiers (UDIs) for some devices.
Germany passed a law in 2019 that provides for a combined premarket review and coverage mechanism for lower-risk devices that provides a staged path for rate-setting with the help of real-world evidence (RWE). That model has caught the attention of other European Union member states, such as France, but may be useful in the U.S. as well, given the FDA’s policy moves for RWE and digital health over the past few years.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has undertaken a massive effort to reform its drug and device regulations, and as it pulls into the homestretch with those reforms, it is setting its sights to postmarketing efforts that include adverse event reporting, conformity assessments, patient-reported outcomes and a universal device identifier program.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has unveiled two guidances for the use of real-world evidence (RWE) in regulatory decision-making. The policy seems limited to pharmaceutical clinical trials, with no indication when it will be expanded to include medical technology.
Despite that the device has been available for more than a decade under the 510(k) program, an FDA advisory committee voted narrowly that the benefits of the Surgimend device for breast reconstruction do not outweigh the risks. Another interesting feature of the application is that the pivotal study was based on real-world evidence (RWE), but while the FDA had direct access to the data, Integra Lifesciences Holdings Corp. did not, thus raising questions about whether RWE is necessarily useful for class III device premarket applications.
TORONTO – Health Canada has proposed a single regulatory framework for medical device and drug clinical trials after broad industry consultation and a hard line drawn by the COVID-19 pandemic for a more streamlined system.