martes, 18 de agosto de 2015

CDRH Industry: : Announcing the International Medical Device Regulators Forum’s (IMDRF) Regulated Product Submission Table of Contents Pilot Program

Today the Center for Devices and Radiological Health (CDRH) is announcing its participation in the International Medical Device Regulators Forum (IMDRF)’s Regulated Product Submission Table of Contents (RPS ToC) Pilot Program. IMDRF is a voluntary group of medical device regulators from around the world, including the FDA, who have come together to accelerate international medical device regulatory harmonization and convergence. IMDRF developed In-Vitro Diagnostic (IVD) and non-IVD Tables of Contents (ToCs) intended to provide internationally agreed upon formats that sponsors can use to file medical device submissions to participating regulatory authorities for premarket clearance or approval.
Starting in September 2015, CDRH is participating in the voluntary IMDRF Regulated Product Submission Table of Contents (RPS ToC) pilot program 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 For questions pertaining to CDRH participation in the pilot, please contact Jodi Anderson at
We welcome your comments and suggestions regarding this pilot. The comment period will be open for 90 days.
Thank you,
Food and Drug Administration
Center for Devices and Radiological Health

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