FDA eases review burden for certain sutures, orthopedic devices in leap-frog guidances
Two new guidances using the US Food and Drug Administration’s (FDA) safety and performance-based pathway make it easier for less complex sutures and orthopedic devices to get to market. The guidances will enable sponsors to get their products cleared by demonstrating that a new product performs as well as its predicate.On 8 April, FDA issued its Surgical Sutures—Performance Criteria for Safety and Performance Based Pathway and Orthopedic Fracture Fixation Plates—Performance Criteria for Safety and Performance Based Pathway final guidances. The agency said it published the documents based on its 2019 Safety and Performance Based Pathway guidance to make it easier for sponsors to get such devices to market. (RELATED: CDRH takes first step to operationalize new safety and performance based pathway, Regulatory Focus 19 September 2019)
The 2019 guidance notes that while a new device using FDA’s 510(k) clearance pathway needs to show it is substantially equivalent to a predicate device, the agency has the authority to only require it to meet similar performance criteria to the predicate device without requiring a direct comparison.
“If a legally marketed device performs at certain levels relevant to its safety and effectiveness, and a new device meets those levels of performance for the same characteristics, FDA could find the new device as safe and effective as the legally marketed device,” FDA said. “Instead of reviewing data from direct comparison testing between the two devices, FDA could support a finding of substantial equivalence with data demonstrating the new device meets the level of performance of an appropriate predicate device(s).”
The two final guidances for low complexity sutures and orthopedic fracture fixation plate devices were leap-frogged, meaning that FDA did not first issue draft versions for public input. Both documents spell out the performance data from certain testing such as sterilization and biocompatibility testing that would be required to demonstrate a finding of substantial equivalence for each type of device. The devices also have certain physical testing requirements specific to them such as testing for a suture’s diameter depending on whether it is absorbable or non-absorbable, and a static four-point bending test for the orthopedic devices.
The guidances also preclude certain more complex versions of the devices from the safety and performance based pathway.
FDA said the guidance on surgical sutures applies to devices that are “intended for general soft tissue approximation and/or ligation, such as use in ophthalmic, cardiovascular, neurological, orthopedic, and dental procedures.” However, sutures made from certain materials such as animal-derived materials, and those that include drugs or biologics are exempt from the guidance.
Similarly, only non-spinal fracture fixation plates with specific product codes are allowed to use the safety and performance-based pathway, according to FDA. The agency says it may determine on a case-by-case basis any additional data that may be necessary to determine if a device is appropriate for the pathway and it advises sponsors to talk to regulators sooner rather than later.
“In situations where you determine that additional testing outside of those identified in this guidance are necessary to determine whether the device is appropriate for the Safety and Performance Based Pathway, we would encourage you to submit a Pre-Submission to engage in discussion with FDA prior to submission of the 510(k),” FDA says in both guidances. “If your device is appropriate for submission through the Safety and Performance Based Pathway, and you choose to use that option, we do not expect you to provide direct comparison testing against a legally marketed predicate device to demonstrate substantially equivalent performance characteristics.”
The two guidances are only the latest to address FDA’s safety and performance expectations for specific devices. Last year, it published similar guidances addressing denture base resins and facet screw systems. (RELATED: FDA outlines safety and performance-based criteria for facet screw systems and denture base resins, Regulatory Focus 30 August 2021)
