A single review program for medical devices?

02 December 2019 | Luis Jimenez | VP of Business Development

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During this year’s Bio-Utah Summit in November 2019, Dr. Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health (CDRH) spoke about the new initiatives and modernization of FDA’s medical device regulatory programs. There have been many changes and improvements to the way FDA regulates Medical Devices, including a new interest in harmonization (watch our Jan 2019 webinar on the subject here).

As part of the update, Shuren reiterated FDA’s continued support for the Medical Device Single Review Program (MDSRP). (Not to be confused with the Single Audi Program MDSAP).  

The FDA has for some years chaired the committee to explore this program at IMDRF (International Medical Device Regulators Forum) meetings. This initiative was also outlined as one of  FDA’s 2018-2020 strategic priorities for CDRH (For the final document click here).

Earlier in the yar, the IMDRF discussed updates to this program and agreed to the basic principles for a single review program for the recognition of requirements and procedures related to pre-market reviews.

What exactly does a Medical Device Single Review Program mean?

It is too early to speculate on the exact mechanics, (after all we yet don’t have a list of interested countries, except that FDA has been very forthcoming about their support). But there are some analogies that provide insights as to what the program could look like in the future. 

We are well familiar with the Medical Device Single Audit Program which provides manufacturers with the ability to certify their technical systems through a single Audit for 5 major countries: US, Canada, Australia, Brazil, and Japan. In theory, the MDSRP represents MDSAP’s counterpart for the Technical File and Pre-Market Reviews. An MDSRP has the potential to streamline registration of Medical Devices in the participating countries.

One approval gets you in?

The exciting part of this is the possibility to circumvent redundancies in regulatory evaluations for registration of medical devices. The potential is a single review for multiple markets. This will deliver a quicker time to market and a much less burdensome process (on regulator and manufacturer alike).

Just as in MDSAP, each jurisdiction would be able to have their own regulatory nuances met, through the specific exceptions and discretionary review requirements to meet each’s respective non-harmonized standards.

In the words of the FDA’s Working Grop Chair: “The Ultimate Goal”:

According to the IMDRF Working Group Update in 2017, the MDSRP is the ultimate goal for several initiatives including the IMDRF strategic priority: “Improve the Effectiveness and Efficiency of Pre-Market Review”.

According to the report:

  • The Program would be:
    • Modeled after MDSAP
    • Aimed at promoting a harmonized approach to assessing conformity with safety and performance regulatory requirements
  • Benefits may ultimately include:
    • Promoting consistency, predictability, transparency, and quality of regulatory programs and criteria for assessing premarket technical documentation for medical devices.
    • Greater global convergence of premarket requirements
    • Reduction of regulatory redundancies – Medical devices reaching patients quicker
  • Examples of considerations that would need to be addressed to develop a program:
    • Training and competency requirements for the reviewer performing the assessment (already completed)
    • Types of submissions or device categories that are to be covered by the program and establishment of specific criteria for each of those
    • Legislative framework of each jurisdiction (e.g. timeframes, flexibility, specific requirements, etc.)
    • Harmonization of submission requirements (e.g. IMDRF ToC)
    • Harmonization of the review process
    • Accreditation of entities that will perform the assessments of premarket submissions
    • Programmatic implementation aspects

At the moment IMDRF are focused on the creation of a harmonized approach to how countries recognize other entities that perform premarket review. A task that quite a mountain to climb, but not an insurmountable one.

Dr. Shuren also confirmed that some of the IMDRF countries were already on board in principle to participate in the program.

As with the MDSAP program, we foresee a pilot MDSRP program to start in the near future.  

Final and wishful thoughts

From our perspective, we applaud the initiative.

International collaboration is a reflection of mutual trust and cooperation between agencies that have historically not been so keen to work together. This initiative would be a landmark development which, if executed correctly, could mean that more novel technologies would become accessible earlier to those in need. It could even mean more affordable devices, and a much-needed workload reduction regulatory body to perhaps more value add activities. Things that we would applaud immensely.

If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)


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