IMDRF Working Groups
The FDA participates on multiple IMDRF working groups. Current work items from these working groups, including pilot programs and other related documents are posted on this page.
Adverse Event Terminology Working Item
The International Medical Device Regulators Forum (IMDRF) has developed the document “IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes” to improve, harmonize, and expand the terminology and systems being used to code information relating to medical device adverse events. The IMDRF adverse event terminology will be composed of four parts:
- terminology for medical device problems,
- terminology for medical device evaluation,
- terminology for patient/user outcomes, and
- terminology for medical device parts/components.
The document consists of general guidelines for adverse event coding as well as a separate annex for each terminology type. At this time, the guideline document as well as the annexes for medical device problems and medical device evaluation have been finalized and are available on the IMDRF webpage.
FDA has adopted the IMDRF terms that are currently published. The IMDRF medical device problem terms align with FDA Device Problem Codes (DPC) and the IMDRF medical device evaluation terms align with FDA Manufacturer Evaluation Codes. FDA has recently updated our coding to retire codes not included in the IMDRF terminology and add codes not previously included in our coding. These new terms have been given new FDA codes and NCI codes. As the other annexes are finalized, FDA will update our codes in those areas as well.
Important note: At this time, the FDA’s eMDR system is not configured to accept the IMDRF codes; however, once all four annexes are completed, we plan to modify the FDA system to accept the FDA code, NCI codes, and IMDRF codes. The FDA coding can be found on our MDR Adverse Event coding webpage.
Regulated Product Submission (RPS) Work Item
The following documents are for informational purposes and the format or arrangement of content described is not part of the current regulatory requirements for 510(k)s and PMAs.
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.
RPS ToC Pilot Program
Since September 2015, the FDA’s Center for Devices and Radiological Health (CDRH) has participated in the voluntary IMDRF Regulated Product Submission Table of Contents pilot program. This program is intended to provide an internationally harmonized 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.
How to Participate
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 specifically related to the IMDRF ToC program, please send an email to [email protected].
For questions pertaining to CDRH participation in the pilot, please contact Kenneth Cavanaugh at [email protected]