The FDA’s Safer Technologies Program, or STeP, is part of an overarching emphasis on safety, and the related draft guidance focuses largely on the process of applying for a STeP device. However, a member of the FDA staff said on a webinar that device accessories – and devices that make other devices safer – are also eligible for the program.

The FDA’s emphasis on medical technology safety has spawned several regulatory innovations, including the STeP program, which is designed to provide expedited reviews for device and diagnostic applications that are “reasonably expected to significantly improve” safety. The draft guidance for the STeP program, released in September, leverages some of the concepts underpinning the breakthrough devices program. The fact that the STeP program prioritizes the related applications makes it complementary to the breakthrough devices program, the agency said in the draft.

The FDA’s Joshua Chetta, a biomedical engineer at the Center for Devices and Radiological Health, said on a recent webinar that there are many eligibility factors that pertain to the STeP program. One of these is that the program is limited to PMA, de novo and 510(k) devices, but devices that are designated under the breakthrough devices program are not eligible for the STeP framework.

Chetta added that the fourth specific eligibility factor is that the candidate device “should provide for an improvement of the safety of another device or intervention.” He said this can be met when the sponsor can demonstrate that the candidate device offers “a specific type of improved safety benefit” for another medical device or for an intervention.

Any such candidate device does not have to be a formal medical device accessory, Chetta said, but the device should be a finished device in any event. He said sponsors can obtain more information about the characteristics of device accessories by checking the Dec. 20, 2017, FDA final guidance for medical device accessories and device classification pathways, which specifically includes software as a type of device that can be deemed an accessory.

Acute, long-term events both applicable

Another eligibility factor is that the device should be reasonably expected to “significantly improve” the benefit-risk profile of a treatment or a diagnostic. The agency’s expectation is that the applicant device achieves this by reducing the occurrence of a known serious adverse event, although that event can be known to take place in either the acute phase or over a longer term.

The second eligibility factor, that of a reduced occurrence of a device failure mode, “should be associated with serious health consequences,” Chetta said. However, that failure mode must be a documented event rather than the subject of speculation or one which can be reasonably inferred. Also corollary to this second eligibility factor is that the hazard addressed by the device may be incurred by someone other than the patient, such as a health care professional, but Chetta noted that inadequate or unclear labeling does not qualify as a substantial safety innovation.

Chetta emphasized that the acceptance of a device into the STeP program does not ensure that the sponsor’s proposed risk classification for that device is the classification the agency will ultimately adopt. The same holds for whether the device will be deemed an accessory.

The sponsor should apply for entry into the STeP program for a given device prior to the associated regulatory filing so that the agency can examine the two considerations in parallel, Chetta said. The FDA will accept multiple devices into the STeP program that are designed to take on a given safety issue, he said.

Devices accepted into the STeP program can make use of a regulatory sprint with the FDA review team to address any unusually difficult questions, and sponsors can make use of traditional pre-submission interactions with the FDA “for those questions or requests that don’t fit into the other mechanisms for feedback,” Chetta said. The sponsor can also request that the FDA provide a regular status update, and he said the FDA intends “to expedite the review process of these requests as resources permit.”

Stand-alone Q-subs only

Chetta said sponsors should use a separate Q-submission filing to deal with any other aspects of that device application, leaving the application for admission into the STeP program as a stand-alone Q-submission. He said the review team would attempt to handle any other Q-submissions for that device in a timely manner so as not to hold up the designation process for the STeP program.

The FDA has not arrived at a clear definition for “significant improvement” over the safety profiles of existing devices, Chetta said, although he noted that the agency’s emphasis is on “those kinds of big public health safety concerns.”

The docket for the STeP devices draft indicates that 14 comments were submitted, but only one submission is visible. Any submissions to the docket that contain proprietary information may not be publicly available to avoid any such disclosures.

The sole visible comment to the docket came from Terri Greulich, a marketing consultant for director of marketing for Medlite ID Inc., of St. George, Utah. Greulich made the case for inclusion of class I devices in the program, citing the example of a device that attaches to the primary or emergency intravenous line. This device would light that line to distinguish it from other lines, and thus reduce line mix-ups and the associated medication errors. Greulich said the ECRI Institute of Plymouth Meeting, Pa., had identified such issues as the fourth most prominent safety concern in 2015.

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