The US Food and Drug Administration (FDA) is working to provide a globally harmonized format for electronic device submissions to regulatory authorities “in the next few years,” said Center for Devices and Radiological Health Director (CDRH) Jeff Shuren during a Wednesday keynote.
CDRH is working with the International Medical Device Regulators Forum (IMDRF) to “establish a medical device single review program.” The program would allow submissions to be used by other regulators, partly or entirely, for decisions on marketing clearances, Shuren explained at the Medical Device Innovation Consortium (MDIC) annual public forum.
In 2015, the center announced
the participation of two of its offices in the IMDRF’s Regulated Product Submission (RPS) Table of Contents (ToC) pilot program on evaluating the agreed upon review structure to ultimately facilitate submission of content data to multiple regulators.
Companies were invited to provide feedback on usability of the ToC structure by participating in the CDRH/IMDRF pilot program. Eligibility was subject to a requirement to submit applications either “sequentially or simultaneously to at least one additional participating IMDRF region.”
CDRH has adopted final IMDRF documentation and coding terminology, including on adverse events, since the 2015 announcement. This supports a unified approach to filing submissions and other regulatory activities, though harmonization changes are still being phased in.
The goal is to create a common dossier, such as the one established for pharmaceutical products, that can be leveraged for more timely patient access in multiple jurisdictions, Don Boyer, president of industry consulting firm BOYER@RegulatorySolns and former senior official at Health Canada, told Focus.
Participating regulatory authorities include EU notified bodies, Brazil's National Agency for Sanitary Surveillance, Australia’s Therapeutic Goods Administration, the China Food and Drug Administration (CNDA) and Health Canada, which is the main coordinator. Last month, Health Canada issued a notice
on its plans to officially adopt the ToC format by next April.
Whether or not a single review program based on ToC formatting will remain voluntary in the US remains to be seen. But “voluntary is not the charge of IMDRF” and harmonization efforts need to be uniform, Patrick Hope, director of the Medical Imaging & Technology Alliance, told Focus
The IMDRF managing committee, which is currently chaired by CNDA, is set to meet in China this month and intends to address this topic. CDRH’s input will be crucial to help inform other regulators worldwide on the path laid out for the new program, according to Hope.
The alignment with other countries on regulated product submissions will help set up a robust postmarket data collection infrastructure to address the uncertainty around a product’s benefits and risks, though “there will always be” remaining uncertainties, Shuren said. Still, the building blocks CDRH is now putting in place can drive innovation in the device space, particularly for smaller patient populations, rare disorders and pediatric patients, according to Shuren.
Other insights Shuren provided at the MDIC event relate to the second meeting of the Patient Engagement Advisory Committee—set for 15 November—which intends to focus on potential uses for patient-generated data from wearables, registries and other sources.
Another area Shuren touched on involves CDRH’s proposal for a major reorganization
that is currently being piloted by three of its offices in an internal shift toward a team-model approach that can better support the total product lifecycle. CDRH has been working on this proposal for three years, and the hope is for it to be “blessed in the very near future,” Shuren said. The new Office of Product Evaluation and Quality “will put us in a much better position in doing the work” already underway in collaboration
Editor’s note: Don Boyer currently serves on RAPS’ board of directors.