The Safer Technologies Program for Medical Devices (STeP) draft guidelines published by the US Food and Drug Administration (FDA) outline a voluntary programme for expediting the approval of promising treatments and diagnostics for non–life-threatening diseases. The guidance was open for public comment until 18 November 2019.

The draft programme is modelled on the FDA’s pre-existing Breakthrough Devices Program (BDP), which exists to accelerate the production of medical devices and device-led combination products (henceforth to be referred to as ‘devices’). Devices that fall under this description provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions than existing products.

STeP instead applies to devices that target an underlying disease or condition associated with morbidities and mortalities that are less serious than those eligible for BDP designation, but the use of which may be associated with serious or life-threatening risks. The agency’s vision is to use STeP to help patients gain more timely access to products that are expected to significantly approve safety of current treatments.

In a statement, FDA Center for Devices and Radiological Health director Jeff Shuren said: “We believe the Safer Technologies Program for Medical Devices will help ensure that we’re giving patients timely access to safe, effective and high-quality medical devices by expediting their development, assessment and review, and by facilitating the generation of the robust evidence required to support product marketing authorizations. We will do this without changing our statutory standards, data requirements or quality of review.”

Medtech trade body AdvaMed has asked the FDA to give concrete examples of devices that do and do not meet standards of “significantly improved safety” in its final guidance.

Which types of device are eligible?

Medical devices and device-led combination products are eligible for this programme if they are subject to review under a premarket approval application (PMA), De Novo classification request, or 501(k) premarket notification.

A PMA is the FDA’s process of scientific and regulatory review of the safety and efficacy of Class III medical devices. Class III medical devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. A PMA is the most stringent type of device marketing application required by the FDA.

The De Novo process provides a pathway to classify novel medical devices, for which general and special controls provide reasonable assurance of safety and effectiveness but for which there is no legally marketed predicate device. Conversely, a 501(k) clearance allows a manufacturer to market a Class I, II or III (in the case that a PMA is not required) device if they can demonstrate that it is substantially equivalent to another legally marketed medical device.

If a device does not fall into one of these categories, it cannot be put forward for STeP.

How can a developer apply?

A request for a device to be included in the programme will be made through a Q-Submission. A Q-Submission allows manufacturers to request feedback from, or a meeting with, the FDA regarding potential or planned medical devices.

The Q-Submission will need to include a comprehensive description of the device and how it functions, as well as the expected safety improvements the device is expected to bring. Applicants will also need to lay out the indications for use of the device, its regulatory history and its planned marketing submission – PMA, De Novo or 501(k).

What does the FDA consider when evaluating a device for STeP?

If a device is deemed appropriate for processing through STeP, the FDA will engage its senior management to expedite its development and regulatory review. In order to be accepted, the device will need to meet a number of criteria.

The FDA says a device, which can be processed through STeP “should be reasonably expected to significantly improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations that provide for one or more of the following:

  1. a reduction in the occurrence of a known serious adverse event
  2. a reduction in the occurrence of a known device failure mode,
  3. a reduction in the occurrence of a known use-related hazard or use error, or
  4. an improvement in the safety of another device or intervention.”

What else do developers need to know?

As resources permit, STeP will include features such as interactive and timely communications with the FDA, review team support, senior management engagement and prioritised review. The FDA believes this sort of feedback may help reduce the overall time it takes to develop a device and achieve marketing authorisation.

Once STeP legislation is finalised, the FDA anticipates a transition period of up to 60 days to implement the programme. It will not accept requests for inclusion in STeP during this period.

What does this mean for the industry?

When STeP is finally implemented, medical device developers will have a pathway through which they can fast-track the approval of safety-improving products, without compromising on quality. Since the introduction of BDP, the FDA has granted BDP status to 71 of 100 applicants and received 13 marketing applications for breakthrough devices. BDP devices are also significantly more time and labour-intensive for FDA staff, so it is hoped that STeP may have even more success.

However, it must be noted that this is reliant on further resources being allocated for STeP. If the same staff who manage BDP are left to manage STeP as well, leaving them asked to do more with the same resources, STeP’s reach may end up being somewhat limited.

Shuren said: “Because technology continues to advance, patients are benefitting from more innovative medical devices that can help improve their health and even save their lives. Safety and innovation are both important priorities for the agency. Improvements in each of these areas are expected to result in increased quality of life and health benefits for patients, while simultaneously providing a reasonable assurance of both safety and effectiveness.”