Regulatory Focus™ > News Articles > IMDRF Launches Backbone of Major New Submission Standard for Medical Devices

IMDRF Launches Backbone of Major New Submission Standard for Medical Devices

Posted 23 April 2013 | By Alexander Gaffney, RAC 

The International Medical Device Regulators' Forum (IMDRF) has released another proposal, the fourth in the last week, detailing an aspect of medical device regulatory submissions that one high-level regulator says could eventually harmonize submission approaches for drugs and devices: The Regulated Product Submission (RPS).

Background

IMDRF launched in 2012 as the regulators-only successor to the Global Harmonization Task Force (GHTF), which disbanded in December 2012 after its device regulatory members decided to split off and form their own juncture without the involvement of industry. At present, organizations involved in the IMDRF include the US Food and Drug Administration (FDA), Australia's Therapeutic Goods Administration (TGA), Brazil's National Health Surveillance Agency (ANVISA), Health Canada, the European Union (EU), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and the Asian Harmonization Working Party (AHWP).

The group has been hard at work, endeavoring to pick up where GHTF left off and increase the pace at which regulatory harmonization occurs. Those efforts have recently borne fruit, with IMDRF announcing the launch of several new guidance documents, among the long-awaited Unique Device Identification (UDI) framework, a medical device single audit program (MDSAP) and new training requirements.

The RPS, however, holds special potential to impact not just the medical device industry, but the pharmaceutical industry as well.

As explained by Kimberly Trautman, FDA's associate director of international affairs at the Center for Devices and Radiological Health (CDRH), in a March 2013 update, IMDRF has been working on a draft table of contents that would constitute the backbone of the RPS standard, which is a sort of electronic common technical document (eCTD) that could then be used to make a single submission that is recognizable by multiple regulatory authorities.

Trautman explained that the IMDRF group is trying to "marry" a similar RPS effort under development by the International Conference on Harmonization (ICH)-a pharmaceutical-focused harmonization group. "Clearly, if we're going to be working on electronic submissions to any one of our particular agencies, we are looking to have a coordinated effort between our different sister commodities such as drugs, devices, biologics and so forth," Trautman said.

This could, in theory, make it much easier for a combination drug-device product to be submitted to multiple agencies around the world.

The Proposal

At the time of Trautman's remarks, the RPS was still under development by IMDRF, which was working on publishing the backbone for industry comment. That backbone is now out, weighing in at 34 pages in length.

Regulators noted that the document is intended to "support a smooth documentation process," but hedged that, "It remains the manufacturer's responsibility to ensure all regulatory requirements are met, and that clear and transparent evidence on conformity to these requirements are provided."

That being said, IMDRF's Table of Contents (ToC) goes on to explain common content between all regulatory authorities involved in the RPS process, including FDA, Health Canada, Brazil's Anvisa, Japan's Ministry of Health, Labor and Welfare (MHLW) and the EU.

That document may be found here.

Testing the Proposal

But more important than the proposal itself may be how it actually functions once put to the test. Unlike regional proposals, where a problem is at least isolated to those who choose to operate in a given market, problems at the IMDRF level would have wide-ranging consequences. Thorough testing of the proposal, in other words, is crucial.

Regulators reiterated that the RPS pilot program is premised on three objectives:

  1. To beta test/validate the RPS 2 Draft Standard for Trial Use (DSTU) to make it "fit for purpose" for the electronic exchange of information.
  2. To establish a comprehensive ToC for premarket applications.
  3. To identify common evidentiary requirements for the market authorization of medical devices.

It is the second of these two objectives that this particular pilot plan focuses on, IMDRF wrote, adding that its ultimate goal is to make it easier for device manufacturers to make global submissions for regulated products.

IMDRF says it wants comments on the draft, and is particularly interested in four areas: Whether the approach is feasible, whether the layout and content of the ToC is useful, whether the terminology used in the document is clear and appropriately standardized, and the usefulness of the pilot phase of the ToC.

Timeline: A Busy Summer

The pilot phase, which Trautman said would be launched in the summer of 2013, is set to include two phases: An initial submissions or pair of submissions intended to be tested in a single jurisdiction, followed by several submissions that would be tested in each IMDRF jurisdiction during Phase 2.

"Testers may base their test submissions on an existing approved device or develop a wholly new real or fictional submission," IMDRF wrote. "Using an existing approved device has the benefit that the Regulators can more directly compare the new ToC to the old ToC. The selection of test submission type and approach for each manufacturer will be established through consultation with the IMDRF ToC Working Group."

The pilot program and all materials submitted through it will be kept confidential and not distributed to non-regulators, the group explained in its document.

The pilot program is expected to be completed by September 2013, with a final report due out in October 2013 regarding lessons learned and the final ToCs, which will be used to support a recommendation for final IMDRF review and endorsement.


IMDRF: All RPS Documents


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