EMERGO SUMMARY OF KEY POINTS:

• The US FDA has proposed a pilot program for more consistent evaluation of medical device submissions’ adherence to voluntary consensus standards.
• The Accreditation Scheme for Conformity Assessment (ASCA) Program would utilize accredited testing laboratories to evaluate registrants’ Declarations of Conformity to various consensus standards.
• The FDA is accepting comment from industry on the ASCA Program through June 30, 2017.

Medical device regulators at the US Food and Drug Administration have begun seeking stakeholder feedback for a proposed system to better evaluate registrants' compliance with voluntary consensus standards.

Specifically, the new FDA notice proposes an accreditation scheme for conformity assessment, or ASCA, pilot program whereby the agency can identify testing laboratories capable of evaluating medical device registrants' declarations of conformity to agency-recognized consensus standards. The parameters of the ASCA program came about during Medical Device User Fee Act (MDUFA) reauthorization negotiations between regulators, industry and Congress.

ASCA goal: More consistent use of consensus standards

The goal of the pilot program, according to US regulators, is to more consistently incorporate use of these FDA-recognized consensus standards in premarket reviews of medical devices. Registrants currently have the option of including Declarations of Conformity in their FDA premarket clearance and approval applications attesting that their devices conform to certain consensus standards, but such standards vary from one another greatly in terms of technical complexity; this complexity makes it challenging for registrants as well as FDA reviewers to determine whether standards have been appropriately applied to regulatory submissions.

Through the ASCA program, the FDA aims to enlist accredited laboratories with the expertise to evaluate device submissions according to consensus standards recognized by the agency.

One less regulatory hurdle for FDA registrants?

Once implemented, the ASCA Program will allow US market registrants to submit their devices to accredited labs for testing; registrants will then be able to provide proof from testing labs that their devise conform to standards as claimed.

“FDA intends to rely on the results from the recognized accredited Test Laboratory for the purpose of premarket review without the need to address further questions related to standards conformance,” states the agency in its notice.

Specific ASCA Program issues for which the FDA seeks input from industry and other stakeholders include:

• Which FDA-recognized consensus standards should be included in the program?
• What would the program need to achieve in order to be considered successful?
• What particular challenges related to use of FDA-recognized standards should be addressed by the program?
• What are the advantages and/or disadvantages of utilizing third-party, private-sector accreditation bodies to identify and accredit testing laboratories that would participate in the program?

The FDA’s comment period closes June 30, 2017.

Related FDA medical device registration resources and services:

• FDA 510(k) premarket notification consulting for medical device companies
• FDA medical device design, process and software validation support
• US FDA 510(k) clearance calculator
• Whitepaper: Preparing a US FDA 510(K) submission