Advancements in the FDA’s Safety and Performance Based Pathway

by | Dec 21, 2020 | FDA, Medical Devices, Pathway, Quality

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 Torsional Strength using ASTM F543 methodology. If you were submitting a 510k via the Safety 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.


1FDA (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

2FDA (Dec 2020) Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway retrieved on 12/20/2020 from: https://www.fda.gov/media/130866/download

Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

More Resources

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De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

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Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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