The Safety and Performance Based Pathway was introduced by the U.S. Food and Drug Administration (FDA) in 2019 to provide an alternative pathway for certain, well understood devices. This pathway was initially launched to help strengthen and align with the agency’s goal to provide less burdensome policies.
In the same spirit, the FDA issued a final guidance on April 11, 2022, establishing the performance criteria for surgical sutures, allowing for clearance of devices through the Safety and Performance Based Pathway. This new guidance, “Surgical Sutures—Performance Criteria for Safety and Performance Based Pathway,” may be found by visiting the FDA’s website at: https://www.fda.gov/media/157490/download.
Surgical sutures that are the subject of the April 11 guidance fall under Class II devices that previously relied upon demonstration of substantial equivalence through direct comparison to a legally marketed predicate surgical suture device.
Included within the scope are both non-absorbable and absorbable sutures that are intended for the approximation and ligation of soft tissue, covering various device indications such as:
- Ophthalmic and Others
Specific product codes and associated regulations are listed within the FDA document with a set of defining characteristics that would render a suture out of scope within the guidance.
Unsurprisingly, sutures that contain atypical or novel materials, animal materials, drug/biologic compounds or unapproved color additives fall outside of the scope of this guidance and therefore, require comparison to a predicate device. With these characteristics, the FDA has indicated that atypical design features and novel sterilization methods fall outside the scope.
Performance criteria identified, include:
- Suture diameter (identified within USP Monographs)
- Needle attachment (identified within USP Monographs)
- Tensile strength (identified within USP Monographs)
- Sterilization and shelf life criteria as identified in FDA-recognized standards
- Resorption profile requirements for absorbable sutures as identified within FDA’s Surgical Suture’s – Class II Special Controls Guidance
Positive Steps for Industry
A potential win for industry comes from the Biocompatibility Testing discussion within the guidance. The FDA points to the use of ISO 10933-1 for identification of required testing, but they’ve offered the opportunity to provide a rationale in lieu of testing where a device is manufactured from identical raw materials under identical manufacturing practices (as a predicate device with the same type/duration of tissue contact).
Specifically, the FDA states that, “changes in geometry are not expected to impact the biological response” of the subject device, and “would typically be sufficient to establish substantially equivalent biocompatibility.”
It is foreseeable that a chemical characterization test would support the claim that materials and manufacturing processes are identical to the predicate device. This is most likely beneficial for suture manufacturers looking to implement line-extensions, as they can be certain their materials and manufacturing processes are the same. This could allow for the elimination of the requirement of complex surface area calculations to justify a risk-based approach to biocompatibility testing.
The FDA also suggests use of a results summary for all completed tests, as well as a Declaration of Conformity (DoC) stating conformance to the appropriate performance criteria (tests 1-8 within the guidance) for a device. It is important that all testing be conducted on sterile finished products, and unless specifically indicated within the test, full test protocols and reports should also be submitted. The agency notes certain test-specific considerations—for example, sutures that do not meet USP diameter requirements may still be eligible for this pathway provided the suture diameter is not oversized by more than 1 USP size.
In closing, manufacturers must take special care when determining the most appropriate regulatory pathway for their devices and rely on many tools/factors. However, this guidance should be a useful tool in navigating this process.
How Can NAMSA Help?
Navigating the FDA regulatory landscape can be overwhelming for any medical device manufacturer—not to mention very cost-intensive. That’s why having the right partner, at the right time, can be invaluable in achieving regulatory requirements, market success and accelerated timelines.
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the FDA. In fact, our internal teams of medical device development experts communicate with the FDA nearly every day. From Pre-Submission meetings, to Pre-IDE preparation and FDA inspection preparation and SAMD/AI/ML reviews, our teams are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers. This expertise is proven to save medical device organizations up to $17M in costs and 23 months in development timelines.
If you are interested in speaking with us about FDA-related activities or other global regulatory strategies, please contact us at: https://www.namsa.com/contact-us. Or, learn more about our development experts by visiting: https://namsa.com/namsa-expertise/subject-matter-experts/
Kelly Kucharczyk, RAC
Kelly Kucharczyk leads NAMSA’s Global Medical Writing and U.S. Regulatory and Quality Services teams. She has developed numerous regulatory strategies and authored submissions with the goal of efficiently getting safe technologies to market. Prior to joining NAMSA in 2019, Kelly specialized in Orthopedic device strategies and submissions with a long history of working with surgical sutures. She is passionate about helping clients expedite their market access timelines through early and on-going development of regulatory strategy, critical assessment of testing, and communication with regulators.