The move marks the first step toward a common format that would be used by all U.S. manufacturers. The pilot was launched in collaboration with the International Medical Device Regulators Forum, whose members include the device regulators of Australia (Therapeutic Goods Administration), Brazil (ANVISA), Canada (Health Canada), China (China Food and Drug Administration), and the European Union (Notified Bodies).
To participate in the program, companies must be making submissions to both the FDA and the aforementioned IMDRF members who are also interested in the common submission format. The common format will be defined by a table of contents. “The ToC provides a comprehensive submission structure that can be used as a harmonized international electronic submission format while minimizing regional divergences and indicating where regional variation exists,” the FDA writes in the Federal Register.
Submission contents will not be shared with other regulators or manufacturers, but feedback about the common format will be shared among IMDRF regulators in order to evaluate and improve the usability of the table of contents. In 2014, IMDRF members agreed to a common format for non-in vitro diagnostic submissions. The new pilot is a step toward a universal common submission format for other devices as well, in the hopes that it will make life easier for companies trying to sell equipment in various countries.
The agency says participation in the program will “provide both local and international benefits for FDA, as it will provide FDA feedback into decisions regarding the ToC’s suitability.”
Up to nine (9) companies can enroll in the pilot program, which lasted from September 2015 to 2016.
REFERENCE: Fierce Medical Devices; 19 AUG 2015; Varun Saxena