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It’s Raining Guidance Docs: FDA Expands Abbreviated 510(k) Program

News article posted on 23 September 2019 on Medtech Insight
Author: Ferdous Al-FaruqueSource of Original Article

Executive Summary

In a new final guidance, the US agency has expanded its abbreviated 510(k) program for certain devices to look beyond conformity assessments and instead look at performance criteria. Alongside the guidance, the agency also released four draft guidances for devices it is considering clearing under the new pathway.


The US food and Drug Administration has published a major final guidance that seeks to further expand its abbreviated 510(k) program. Alongside the guidance, regulators have also proposed corresponding draft guidances that would guide the types of medical devices that could be reviewed under the expanded program.

The agency released the guidances on 19 September, only a week after it published four updated guidance docs aimed at clarifying the agency’s thinking on its Special and Abbreviated 510(k) Programs, and explaining how to format traditional and abbreviated 510(k) submissions, as well as when the FDA would issue refuse-to-accept letters for 510(k) submissions. (Also see “Wave Of Overhauled FDA 510(k) Guidance Documents Aims To Streamline Reviews” – Medtech Insight, 18 Sep, 2019.)

“This guidance expands the concept of the Abbreviated 510(k) Program by explaining how substantial equivalence for certain device types may be demonstrated in a way that is less burdensome, but at least as robust.” – The FDA

The 510(k) pathway is the FDA’s most popular program that sponsors use to get new products to market since it imposes fewer data requirements, and manufacturers only need to show that their device or diagnostic test is substantially equivalent to a product that’s already on the market. Since its inception, the 510(k) program has continued to grow and the FDA has tried to streamline the pathway while also trying to improve predictability of how products are reviewed.

Part of that expansion includes developing the Special 510(k) Program, which allows original sponsors to update their products over time, and the Abbreviated 510(k) Program, which relies on the use of guidance documents, special controls and recognized standards.

The Safety and Performance Based Pathway guidance expands on the principles of the Abbreviated 510(k) Program by looking at other factors, such as whether the device meets certain performance criteria. The sponsor, however, still has to refer to a predicate device because legally all 510(k) products are required to do so.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, first mentioned the idea of expanding the alternative pathway to Medtech Insight in a 2017 interview. At that time, Shuren said he expected that expanding the alternative pathway could offer a more streamlined route for companies, while producing more robust data supporting the device. (Also see “A No-Predicate 510(k) Future? Pending US FDA Policy Might Forge A Path” – Medtech Insight, 15 Dec, 2017.)

TheThe new final guidance, “Safety and Performance Based Pathway,” is meant to outline a pathway for what the agency says are certain well-understood device types, where a submitter can demonstrate that their product meets pre-identified performance criteria. The draft version of the guidance was issued early last year in response to concerns from industry and the FDA that the alternative 510(k) pathway was too limiting and hence under-used in its current form. (Also see “Proposed FDA Guidance Would Provide Alternate Route For 510(k) Applications” – Medtech Insight, 11 Apr, 2018.)

“This guidance expands the concept of the Abbreviated 510(k) Program by explaining how substantial equivalence for certain device types may be demonstrated in a way that is less burdensome, but at least as robust,” the FDA says. “Use of this expanded program may also make the review of 510(k) submissions more efficient, thereby reducing burdens on the agency and possibly review times for individual submissions.”

Beyond Conformity, Looking To Performance

The agency notes that under the Abbreviated 510(k) Program, the FDA looks at whether the sponsor’s device conforms to certain standards, agency guidance docs and special controls to determine if it is substantially equivalent to predicate devices. Similarly, under the performance pathway the agency will look at whether the device meets certain performance expectations, which may be based on FDA guidances, consensus standards and special controls. While in some situations, performance criteria may be explicitly defined by the FDA, in other situations it may be based on a more quantitate understanding of the device.

“In the … Safety and Performance Based Pathway, a submitter would use robust versions of those same mechanisms, which contain all the performance characteristics necessary to support a finding of substantial equivalence for a device type, rather than using direct predicate comparison testing to support a finding of substantial equivalence for some of the performance characteristics,” the FDA says.

The final guidance notes that sponsors that want to know whether their device falls within the scope of the guidance should reach out to the FDA for clarity. The agency also says it believes it will be able to determine if a product qualifies for the pathway without reviewing the data.

“However, where FDA determines that additional data are necessary to make these determinations, the agency may, on a case-by-case basis, review that data before determining whether or not the device is appropriate for this Safety and Performance Based Pathway,” the FDA adds.

The agency says it will keep a list of device types that can be reviewed under the new pathway accompanied by guidance documents for each device type with details about their performance criteria, as well as recommended testing methods and other information.

With that in mind, the FDA released four draft guidances for performance criteria for conventional foley catheterscutaneous electrodes for recording purposesspinal plating systems, and orthopedic non-spinal metallic bone screws and washers.

The agency says it reserves the right to modify – and even remove – devices and guidances that it decides are not right for the pathway.

“In such a case, we intend to either remove that device type from the list or note on the list that additional testing may be necessary while the underlying source(s) of the performance criteria are updated,” the FDA says. “Changes to the list, ie, when a device type is removed from the list or an updated final guidance is issued, would apply prospectively to devices for which a 510(k) has not yet been submitted.”




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