Regulated Product Submission (RPS) Work Item
The International Medical Device Regulators Forum (IMDRF) developed an In-Vitro Diagnostic (IVD) and a non-IVD Table of Contents (ToCs) intended to provide an internationally agreed upon format that sponsors can use to file medical device submissions to participating regulatory authorities for premarket clearance or approval. The tables below are the Classification Matrices proposed by the FDA to describe the relevant elements of the ToCs for those filing with the FDA. These matrices contain PMA and 510(k) elements for In-Vitro Diagnostic (IVD) devices and for non-IVD devices.
CDRH Participation in RPS ToC Pilot Program
Starting in September 2015, CDRH is participating in the voluntary IMDRF Regulated Product Submission Table of Contents pilot program. This program is intended to provide an internationally harmonized, modular format for use when filing medical device submissions to regulatory authorities for market authorization. The pilot will provide industry, IMDRF and CDRH staff the opportunity to test the usability of the internationally agreed upon format.
Sponsors who are submitting a Premarket Notification (510(k)) or Premarket Approval (PMA) applications to either CDRH’s Office of Device Evaluation or Office of In Vitro Diagnostics and Radiological Health, and who are also submitting the application to another participating regulatory authority are eligible to participate. Currently the participating regulatory authorities are Australia (Therapeutic Goods Administration), Brazil (ANVISA), Canada (Health Canada), China (China Food and Drug Administration), and the European Union (Notified Bodies).
For more information about this pilot and CDRH’s participation, please see the pilot’s formal announcement in the Federal Register.
For questions related to the IMDRF pilot, please send an email to email@example.com. For questions pertaining to CDRH participation in the pilot, please contact Jodi Anderson at Jodi.Anderson@fda.hhs.gov