The FDA recently published four Final Guidance documents for medical devices involving dental-related products. These guidance documents cover the criteria for utilization of the Safety and Performance Based Pathway. Under this type of pathway, medical device manufacturers have the option to use the performance based criteria identified in the guidance to support substantial equivalence, as opposed to a direct comparison of the performance of the device to a predicate. In essence, it represents an expansion of the concept for the Abbreviated 510(k) pathway for certain device types. The four new guidance documents are as follows:
The Safety and Performance Pathway may be utilized when the FDA has determined:
· The new device has the same indications for use as, and technological characteristics that do not raise different questions of safety and effectiveness than, the identified predicate; AND
· The new device meets all the FDA-identified performance criteria.
It’s important to note that even under this pathway, submissions will still need to identify a predicate for certain aspects of substantial equivalence. However, instead of performing direct comparison testing to demonstrate that the device is as safe and effective as the predicate, manufacturers will have the option to use this pathway to demonstrate substantial equivalence as appropriate.
The FDA plans to continually evaluate other device types for potential application of the Safety and Performance Based Pathway, and stakeholders may suggest device types for the FDA to consider in this regard. Suggestions can be provided to the FDA using docket number FDA-2018-D-1287 at www.regulations.gov.
If you need any assistance with respect to Quality or Regulatory Compliance matters for your devices, please contact us at PRP. We understand how challenging it can be to maintain compliance while managing your day-to-day operations. We have a large, experienced team of Med Device QA/RA consultants throughout the country who can seamlessly integrate with your team to fill any gaps in expertise or bandwidth, ensuring you stay on track with your compliance goals. We would welcome the opportunity to work together!