Dive Brief:

• FDA has finalized guidance on a pilot program that will allow accredited laboratories to carry out premarket testing of medical devices.

• The final guidance documents released Thursday feature substantial changes from the draft FDA released for consultation one year ago, including a major expansion of the section explaining what the pilot means for device manufacturers.

• FDA overhauled the guidance after feedback from groups including AdvaMed, which broadly welcomed the pilot but identified the need for additional clarity, details and examples in several parts of the document. 

Dive Insight:

The 2017 reauthorization of the Medical Device User Fee Amendments committed FDA to the creation of the Accreditation Scheme for Conformity Assessment (ASCA) pilot. Through ASCA, the agency is seeking to help build a body of accredited testing laboratories that assess whether devices conform to consensus standards. In doing so, FDA could make conformity testing more consistent and drive international harmonization.

Organizations affected by the voluntary pilot see its potential, with device manufacturing company Cook telling FDA “if the ASCA program can successfully increase confidence in testing, reduce review questions, and reduce review times, we agree that would be highly beneficial.” However, Cook and others foresee barriers to realizing those benefits, leading them to submit lengthy responses to FDA’s call for feedback.

FDA responded with final guidance that diverges significantly from the draft it released last year. The final guidance features an expanded section on the processes and policies for device companies that walks through the steps manufacturers will need to complete to get products tested.

The first step is to select an ASCA-accredited testing laboratory. FDA is advising manufacturers to look at the scope of a laboratory’s accreditation, which is detailed on the ASCA website, when deciding whether a provider is a good fit for a project. The next step is to develop a test plan. FDA said device manufacturers may choose to work with a laboratory to develop a plan. However the plan is devised, the manufacturers should consider all relevant guidelines and the impact of deviations.

Once testing is complete, manufacturers can use the results to support a premarket submission. FDA said manufacturers that use accredited laboratories will still need to document how testing supports premarket authorization and address other relevant information in their submissions. Applicants should include a cover letter containing details of the accredited laboratory used and a declaration of conformity to an FDA-recognized consensus standard.

Other sections of the guidance underwent similarly significant changes between the draft and final versions. For example, FDA has expanded a section on the suspension of ASCA accreditation, notably by adding details of the situations that may lead it to act against a laboratory. The guidance states a suspension may be needed when periodic audits show a laboratory is generating unreliable results. 

FDA published the final guidance on the ASCA pilot alongside two related documents. One of the texts is the final guidance on biocompatibility testing of medical devices for the ASCA pilot, while the other addresses the basic safety and essential performance for equipment assessed in the program.

The agency will host a webinar regarding the guidances on Oct. 22.