U.S. Food and Drug Administration issued the following announcement on Sep. 19.
The U.S. Food and Drug Administration today announced that, as a first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices. These are anticipated to be the first device types eligible for the new, voluntary premarket notification pathway to market devices, which was first announced in 2018 and finalized through guidance earlier this year.
The initial device types being considered for eligibility for the Safety and Performance Based Pathway under the draft guidances issued today include:
- Conventional foley catheters
- Cutaneous electrodes for reporting purposes
- Orthopedic non-spinal metallic bone screws and washers
- Spinal plating systems
The Safety and Performance Based Pathway provides an option to medical device manufacturers seeking premarket clearance of certain, well-understood device types. With a premarket notification, also known as a 510(k), a manufacturer demonstrates that its product has the same intended use and the same technological characteristics as a device already on the market (known as a predicate device); if the product has different technological characteristics, the manufacturer must demonstrate that its product is at least as safe and effective as, and does not raise different questions of safety and effectiveness than, the predicate device. Manufacturers often conduct direct comparison testing to demonstrate that a new device is as safe and effective as the predicate device. In some cases, predicates may be older and may not reflect modern technologies embedded in new devices. In the new pathway, the safety and performance characteristics of new devices are evaluated against a set of FDA-identified objective and transparent metrics consistent with the safety and performance characteristics of modern predicates. Devices being reviewed and cleared under this new pathway must still meet regulatory requirements for safety and effectiveness; however, the FDA expects this pathway to promote a competitive marketplace for developing even safer, more effective technologies, ultimately giving patients timely access to more beneficial medical devices.
These first four device-specific guidances were chosen because for these device types, the agency had already worked to develop performance criteria and/or FDA-recognized consensus standards exist for the performance of these devices. The FDA is soliciting public feedback on these guidances, which will assist in the finalization of the initial device-specific guidances and also aid in expansion of the pathway to other types of medical devices in the coming months.
In addition to publishing these four draft guidances, the FDA is also updating the Safety and Performance Based pathway guidance issued in February 2019 to further clarify the information the FDA will review in a 510(k) using the Safety and Performance Based Pathway.
In February 2019, the FDA announced the framework for the Safety and Performance Based Pathway through final guidance. It is optional and will not change existing review processes.
Original source can be found here.