One of the FDA’s initiatives for 2021 is to streamline the 510(k) pathways, allowing more efficient access to new medical technologies. Part of this streamlining is enhancing the Safety and Performance Based Pathway, which is an alternative route to traditional 510(k) clearance aimed at moderate-risk devices. With this pathway, a medical device firm would only need to demonstrate that their device meets the FDA’s established safety and performance criteria and would not need to provide a direct testing comparison to a predicate device...

1. Advancements in the FDA’s Safety and
Performance Based Pathway
By: Madison Wheeler
One of the FDA’s initiatives for 2021 is to streamline the 510(k) pathways, allowing more efficient
access to new medical technologies. Part of this streamlining is enhancing the Safety and
Performance Based Pathway, which is an alternative route to traditional 510(k) clearance aimed
at moderate-risk devices. With this pathway, a medical device firm would only need to
demonstrate that their device meets the FDA’s established safety and performance criteria and
would not need to provide a direct testing comparison to a predicate device.1
As long as your device has the same indications for use and technological characteristics
as a predicate, and your device meets all of the FDA identified performance criteria, you can
leverage the Safety and Performance Based Pathway. As part of this effort, the FDA is identifying
certain devices that are appropriate for the pathway and establishing guidances on those devices,
which identifies the specifications that must be met. Currently, the following types of devices all
have guidances for the Safety and Performance-Based pathway: Spinal Plating Systems,
Orthopedic Non-Spinal Metallic Bone screws and washers, Magnetic Resonance Receive-Only
Coils, Cutaneous Electrodes for Recording Purposes, and conventional foley catheters.
Each of these device-specific guidances provides performance criteria for that particular
type of medical device. Each guidance gives you an understanding of which FDA-recognized
consensus standards your device has to show conformance to. For example, the guidance device
for Orthopedic non-spinal metallic bone screws/washers lists all of the ASTM standards that your
device must demonstrate conformity to. The guidances also list out the specific tests and
accompanying performance criteria; so, for example, one of the tests for the bone screws/washers
is TorsionalStrength using ASTMF543methodology.Ifyou weresubmitting a 510kvia theSafety
and Performance Based Pathway for this type of device, you will need to demonstrate that your
device can meet this standard.2
The agency has made it clear that there will be more guidances released to support more
devices through the Safety and Performance Based Pathway. Additionally, the FDA would like
industry stakeholders to suggest device types for consideration for the program. If you have a
medical device that applies to the Safety and Performance Based Pathway, EMMA International
can help! Contact us at 248-987-4497 or email info@emmainternational.com to get started.
1 FDA (Dec 2020) Safety and Performance Based Pathway retrieved on 12/20/2020 from:
https://www.fda.gov/medical-devices/premarket-notification-510k/safety-and-performance-based-
pathway#whatdevice
2 FDA (Dec 2020) Orthopedic Non-Spinal Metallic BoneScrews and Washers – Performance Criteria for Safety and
Performance Based Pathway retrieved on 12/20/2020 from: https://www.fda.gov/media/130866/download