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A newly finalized guidance document from US FDA emphasizes consensus standards rather than predicate comparisons for establishing substantial equivalence for 510(k) devices.

The new approach, which FDA is calling the "Safety and Performance Based Pathway," effectively expands the abbreviated 510(k) pathway as an alternative for more 510(k) devices, though it will be optional.

The new pathway is a key component of an ongoing FDA project to revise and update the 510(k) pathway. The agency is also seeking ways to encourage companies to, when they are relying on the more traditional predicate-comparison 510(k) pathway, to rely on more recent predicate devices rather than products that have been on the market for many years.

FDA says the Safety and Performance Based Pathway will offer a more modern and efficient approach for "certain, well-understood device types." But device companies, in response to an April 2018 draft version of the guidance, say FDA may be over-hyping the impact of the new 510(k) approach, and say more details are necessary. (Also see "FDA's Alternative 510(k) Proposal Falls Flat With Industry" - Medtech Insight, 20 Jul, 2018.) The agency, however, continued to tout the impact of the new alternative approach on releasing the final document.

“The benefit of this approach is that the pathway will benchmark modern technology against modern standards while, at the same time, offering a potentially more efficient way to demonstrate that a new device is substantially equivalent to devices already on the market, and thereby ensure patients have timely access to beneficial products,” FDA said in a statement announcing the guidance. “We also believe this new approach may drive greater market competition to develop safer devices.”

The pathway allows sponsors to establish substantial equivalence by showing that the new device meets FDA-set performance criteria that reflect current technological principles and the safety and performance of modern predicate devices. The guidance document says the performance criteria could be based on FDA guidance, consensus standards, or special controls. “In order to identify the specific set of performance criteria appropriate to satisfy a submitter’s comparison to an appropriate predicate for a given device-type, FDA would ensure that those performance criteria represent performance that meets the performance of one or more existing, legally marketed devices of that device type,” the guidance states.

The guidance further states that performance criteria could only be used if the indications for use and technological characteristics of the new device don’t raise different questions of safety and effectiveness than the identified predicate; the performance criteria match the performance of legally marketed devices of the same type as the new device; and the new device meets all the performance criteria.

FDA would also be able to ask for additional data or more details about the testing methods if needed to establish substantial equivalence.

Still To Come: List Of Eligible Devices

A list of device types eligible for the new pathway will be posted to FDA’s website and detailed in future guidance documents, which will also set applicable performance criteria. Additionally, FDA plans to hold a webinar to explain how the pathway will be implemented soon after it issues the first device-specific guidance document.

The agency also plans to occasionally review the device types and performance criteria set under the pathway to ensure they’re still appropriate.

Seeking Comment On Aged-Predicates Plan

In addition to the final guidance, FDA also issued a notice seeking comment on plans it have floated to discourage use of older predicates. FDA has said it is considering publishing online devices that rely on predicates more than 10 years old as a "market-based" strategy.

The agency is asking for comment specifically on these questions:

  • Should FDA publish a list of devices using older predicates? If so, what should the time limit be?

  • Should FDA use other criteria to select devices with predicates that might be problematic?

  • Are there other actions FDA should take to encourage the use of newer predicates?

  • Should FDA seek new statutory authority to take actions such as making some older devices ineligible as predicates?

So far, device-industry stakeholders have been cold to the idea of a publicizing devices based on the age of the predicate, arguing that 10 years or any other cut-off point is arbitrary. There’s no clear dividing line at 10 years, and some simpler devices may not change much or become inappropriate predicates over that timeframe, industry observers told Medtech Insight. (Also see "An FDA Age-Based Predicate Policy Would Be Arbitrary, Reg Experts Complain" - Medtech Insight, 12 Dec, 2018.)

Comments on these issues can be submitted to the docket number FDA-2018-N-4751 until April 22, 2019.

From the editors of The Gray Sheet


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