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Accelerated pathways for innovative medical devices

Published by Isabella Greenock, Medical Device Paralegal on

Bringing medical devices to market is a process that often takes years. Manufacturers are required to collect and compile large volumes of evidence in advance of their regulatory approval assessment which, in turn, can take many months to complete. 

However, there are situations where it is considered imperative that particular devices make it to market as soon as possible. This will be the case, for example, where a medical device addresses a previously unmet need which would bring significant benefits to patients. Therefore, several jurisdictions have developed accelerated market access pathways which allow certain devices to reach patients more quickly.

In this post, we discuss some of the existing accelerated regulatory pathways for medical devices, as well as proposals for a new accelerated access pathway in the UK.

United States

The FDA has been operating its Breakthrough Devices Program since 2016. The aim of this pathway is to provide patients with rapid access to eligible medical devices. Devices will be eligible for the Program where they meet both of the following criteria:

  1. the device provides for more effective treatment/diagnosis of life-threatening or irreversibly debilitating human diseases or conditions, and
  2. the device meets at least one of the following:
    • represents a breakthrough technology 
    • no approved or cleared alternative exists
    • offers significant advantages over existing approved or cleared alternatives
    • device availability is in the best interest of patients.

The FDA reviews all applications for the Breakthrough Devices Program and issues decisions within 60 days of receipt. Since its inception, the number of devices accepted for the Program has increased year-on-year, with 206 devices being granted breakthrough designation in 2021.[1]

Where applications are accepted, manufacturers can benefit from increased opportunities to communicate with the FDA (e.g. through sprint discussions, data development plan discussions and clinical protocol agreement discussions). Manufacturers will also receive prioritised review on future regulatory submissions, such as Q-Submissions, Investigational Device Exemption (IDE) applications, and marketing submissions.

Australia

Australia currently operates a priority review pathway which grants designated devices ‘front-of-queue’ status for their conformity assessment applications. Such devices still need to comply with all the relevant legal requirements, but will be expedited through the regulatory approval process.

To obtain a priority device designation from the TGA, the following three criteria must be met:

  1. the device is intended for the monitoring, treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition,
  2. there is currently an unmet need for the device, and 
  3. the device offers a major clinical advantage.

Manufacturers need to make a persuasive argument for all three criteria using epidemiological and clinical evidence. The TGA notes that the third criterion is most typically an issue as it requires that the device provides an advantage (in terms of its safety and/or performance) that goes well beyond the minimum threshold of clinical significance.[2]

United Kingdom

The UK does not currently offer an accelerated market access pathway for medical devices. However, the MHRA, in collaboration with the National Institute for Health and Care Excellence (NICE), is planning to establish an Innovative Devices Access Pathway (IDAP). At the moment, there is no clear timeline for the pathway becoming operational. Before any necessary legislative amendments can be made, the pathway will first need to be piloted with medical device companies.

It is expected that the IDAP will be available to devices that address critical unmet needs in the NHS.[3] The pathway will allow manufacturers to work with the MHRA and other partners to generate evidence that meets the needs of regulatory assessment bodies. General market access advice may also be offered.

As with the US and Australia, the IDAP will not exempt devices from the relevant legal requirements. Instead, it will provide a faster route for eligible devices to progress through the usual conformity assessment process. Therefore, manufacturers will still need to ensure that their devices comply with the requirements of the UK Medical Device Regulations 2002, as well as any other applicable laws.

How we can help

Regtik, our healthcare regulatory explorer tool, can help you navigate the legal maze by walking your product through a series of simple questions designed to determine whether it qualifies as a medical device and, if so, what class it falls under. It is able to provide results for various jurisdictions (the US, EU, UK and Australia) in one single assessment and can be used multiple times on different versions of your product.

If you are interested in learning more about Regtik or would like to request a demo, please contact any member of our team or register your interest below.

 

[1] See FDA “Breakthrough Devices Program” for a breakdown of the number of devices accepted for the Program each fiscal year (note, figures for 2022 are incomplete and only include designations made before 30th  September)

[2] TGA, Priority applicant guidelines for medical devices (including IVDs)

[3] NHS Accelerated Access Collaborative, Innovative Devices Access Pathway (IDAP)