Dive Brief:
- FDA device center chief Jeff Shuren says the FDA is actively exploring the potential for a Medical Device Single Review Program shared by several countries though the International Medical Device Regulators Forum, speaking at The MedTech Conference in Philadelphia.
- The idea, laid out in FDA’s 2018-2020 Strategic Priorities for the Center for Devices and Radiological Health, would explore the potential for "the market authorization decision made by one" country partaking in the MDSRP to "be relied on wholly or in part to support marketing authorization by other participating jurisdictions." FDA notes that under such a program the agency would not change its regulatory standards for clearance or approval.
- Shuren emphasized to conference-goers the program is still very early in development, but noted there is mutual interest from other countries, adding that FDA is in discussions to possibly pilot a single review approach.
Dive Insight:
Shuren said that he cannot disclose too many details on which countries are interested in piloting a single review program, and said it still remains to be decided what type class of products may be examined in a pilot.
"This is a program, if it were to be created, where the marketing authorization decision by one participating jurisdiction is relied on in whole or in part by the other jurisdictions," Shuren said. "That is the idea, much like the [Medical Device Single Audit Program] relying on the audits that are performed by other countries."
Another obstacle is that the IMDRF has not yet formally agreed to consider the program, but Shuren says that he anticipates that it will be a topic of discussion at the body within the next year. The Center for Devices and Radiological Health chief says that the prospective for a single review program was the impetus for the U.S. proposing the Good Regulatory Review Practices Working Group at IMDRF.
Still, the FDA "got a commitment" to "put into place the building blocks for MDSRP," Shuren said.
“So already we've issued confidence training conduct requirements for regulatory reviewers. We've updated the essential principles for safety and performance to more align with practices today, and the management committee for IMDRF just approved issuing the final documents. That will be coming out very shortly,” he said.
The newest IDMRF work item is the creation of a harmonized approach to how countries recognize other entities that perform premarket review. IMDRF also is reviewing comments on a document on principles of labeling with a goal of issuing a final version in March, according to Shuren.
"To have MDSRP, here's what you need: you need to have confidence in those that do the review," Shuren said. "So here are the pieces. We laid out what we expect a third party to have, the confidence, the training, and we are moving towards recognition."
It is critical that all countries working towards a MDSRP are all reviewing similar kinds of evidence against the same standard. The U.S. device head pointed to the IMDRF table of contents and review summaries as items that are important to align to share an understanding of a device's benefits and why it may be deemed safe and effective.
"I can tell you several countries are already in discussions with us to maybe pilot this approach," Shuren said. "So we are going to look forward to doing some pilots with some other countries together and get MDSRP off the ground."