A proposed position paper on time periods for notified bodies to roll out guidance documents aims to introduce greater predictability. But has the EU notified body organization gone too far with its proposals?
In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software must meet all four criteria to be excluded.
The FDA is moving forward with its commitment to strengthen and modernize the 510(k) program. The Safety and Performance Based Pathway is designed to provide a direct and transparent approach to demonstrating safety and effectiveness of low to moderate risk devices that can meet FDA-identified performance criteria to demonstrate substantial equivalence.
Background information on the Safety and Performance Based Pathway and guidance documents can be found here.
Below is a summary of the nuances that FDA wants your organization to consider if you are in the process of submitting a 510(k) or are considering submitting a 510(k) for well-understood Class II devices through the new Safety and Performance Pathway for Certain Device Types.
First, manufacturers must determine if the device is appropriate for the pathway. The scope of each device-specific performance criteria guidance identifies device types that are appropriate. The guidance indicates which performance device-specific criteria need to be meet, and all criteria outlined must be met.
Secondly, it is still necessary to identify an appropriate predicate for your submission, even though it is not necessary to conduct side by side performance testing of the subject test to the predicate device.
Third, new submissions through the Safety and Performance pathway are evaluated through the same 510(k) substantial equivalence decision flowchart as before. What is unique about this pathway is that to demonstrate performance the subject device must meet all of the FDA identified criteria listed in the device specific guidance. FDA believes this is important as criteria to appropriately determine substantial equivalence “when the indications for use and technological characteristics do not raise different questions of safety and effectiveness from that of the predicate device. And, that the criteria align with one or more predicates of the same device type.”
The Premarket Notification 510(k) Program is the pathway used by manufactures of low- to moderate-risk devices that are substantially equivalent to a device already on the market. Device manufacturers can submit 510(k)s as Traditional, Special, or Abbreviated. See our previous post for an overview of the 4 guidance documents released by FDA in September of 2019.
The Safety and Performance Based Pathway Guidance for Conventional Foley Catheters and Cutaneous Electrodes for Recording Purposes are the first device type guidance documents release by FDA for the expanded Abbreviated Premarket Notification 510(k) Program. This pathway sets the stage for device manufacturers to use performance measures in place of direct comparisons against predicate devices. The direct use of performance measures for devices that qualify for the abbreviated 510(k) Safety and Performance Based Pathway is expected provide manufacturers with substantial savings of both time and resources.
The Safety and Performance Based Pathway, as an expansion of the Abbreviated 510(k) pathway announced by FDA in February of 2019, is designed to be used for well understood device types. Follow the link below for specific information on the program.
Certain class II moderate risk devices are able to use the Safety and Performance Based Pathway to gain clearance for marketing if they can demonstrate that they meet FDA’s modern performance criteria. Under these criteria, the device must be demonstrated to be as safe and effective as other devices of the same type that are already on the market that conform to the FDA-identified performance criteria. The Safety and Performance Pathway is appropriate when FDA has determined:
The new device has the same indications for use as, and technological characteristics that do not raise different questions of safety and effectiveness than, the identified predicate; and
The new device meets all the FDA-identified performance criteria.
A guidance document was released in September 2019 that describes the optional pathway and provides “FDA’s current thinking on expanding the concept of the Abbreviated 510(k) program for demonstrating substantial equivalence for premarket notification (510(k)) submissions.”
This newest expansion of the Abbreviated 510(k) Program provides device manufacturers the option to use the performance criteria proposed in the guidance to support substantial equivalence in place of direct comparison of performance of the device to that of a predicated device.
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.
[Free Webinar] IVDR Readiness: Creating a Blueprint to Build a Strong PER
Join us on Wednesday, June 7th, 2023 at 11 AM PST, as our regulatory experts discuss the process of writing a PER, with careful attention to the importance of aligning technical documents to create a cohesive, well-organized report.
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