Mary Beth Ritchey, RTI Health Solutions
U.S. medical device regulation legislation
In the U.S., the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) is due to expire Sept. 30. A new bill including updates for medical devices has been approved by the House and Senate and is now with President Donald Trump for signature.
There are components of this legislation that are very exciting for those of us who work with data gathered during actual clinical experience. One component directs the gathering of active surveillance data (rather than the “passive” reporting of safety- and malfunction-related events). This data gathering will be addressed through the National Evaluating System for health Technology (NEST), which is under development as a new platform for gathering and interpreting clinical experience data, both pre- and post- market.
NEST, part of the Medical Device Innovation Consortium (MDIC), now has a coordinating center and a newly named steering committee. This new platform is intended to update surveillance for medical devices to be more relevant to patient and clinical experience. In addition to active surveillance pilot activities, as part of their remit from the FDA-industry agreements, NEST will establish mechanisms for expanding indications and eliciting data for new claims and new indications for medical devices.
Medical device regulation in the E.U.
The EU has also updated medical device regulations this year. General and active (implanted and electrical component) medical device regulations were previously separate, but are now all under one regulation.
As part of the new directive, post-market clinical follow-up (PMCF) must become more transparent. Under previous regulation, PMCF study planning and results documentation was kept within a device company and only had to be revealed when specifically asked for by a regulator (e.g., during an inspection); companies were not required to share the results publicly. Under the new regulation, the PMCF plans and results will be submitted for evaluation on behalf of regulators. Companies will provide information publicly over time and will be reporting post-market studies more transparently. This is a major change for the industry.
This level of transparency brings medical device development practices into closer alignment with drugs. It will likely increase the level of rigor applied in these studies as well as improve documentation. In addition, companies will be able to incorporate methodology and infrastructure aligned with the needs of medical devices. It will be imperative for medical device companies to understand these changes in the post-market space.
These new regulatory advances pose exciting challenges and opportunities for the development of meaningful use of “real-world data” and for continued design, methodologic, and strategic research regarding the patient and clinical experience.
Mary Beth Ritchey is principal epidemiologist for medical devices at RTI Health Solutions (Research Triangle Park, N.C.).