FDA loosens review process for certain orthopedic devices

Alan Condon -  

The FDA has issued two guidelines that make it less complex for medtech companies to commercialize orthopedic devices and sutures using its safety and performance-based pathway, according to the Regulatory Affairs Professionals Society.

The guidelines, relating to orthopedic fracture fixation plates and surgical sutures, will allow sponsors to get their products approved by demonstrating that the new product performs as well as its predecessor. The FDA did not provide first issue draft versions of the documents for public comment.

Orthopedic fracture fixation plates and surgical sutures are required to meet the agency's standards in sterilization and biocompatibility tests as well as physical tests specific to each type of product, such as a static four-point bending test for orthopedic devices and testing a suture's diameter depending on whether it is absorbable or non-absorbable, according to the report.

The guidance on sutures applies to devices designed for "general soft tissue approximation and/or ligation" in specialties including orthopedic, cardiovascular and neurological, but excludes sutures made from animal-derived materials and products that comprise drugs or biologics, the FDA said.

The agency also said that only non-spinal fracture fixation plates with specific product codes can use the safety and performance-based pathway.

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