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Week #100

Understanding the FDA-ASCA Program

What is FDA-ASCA?

ASCA is an FDA acronym meaning “Accreditation Scheme for Conformity Assessment”. The FDA has developed a system for accreditation of experienced medical testing laboratories to perform conformity assessment of medical devices to specific FDA consensus standards. The FDA calls this new program “ASCA”. The initial FDA-ASCA “pilot” program covers Basic Safety & Essential Performance as specified in the 60601 & 80601 series of consensus standards.

What is the FDA-ASCA Pilot?

  • Voluntary program that medical device manufacturers can choose to utilize to help streamline the FDA Submission Review Process
  • Encourages use of voluntary FDA consensus standards in device development and review
  • Aligns with the well-established electrical product safety certification infrastructure in the US, Canada, EU, and Internationally
  • Helps the medical device manufacturer speed up the FDA review process by providing a Submission Package that includes a Test Report from an FDA Accredited Test Lab demonstrating compliance with the specified consensus standard(s). Based on the vlaidation provided by this report, the Manufacturer in turn prepares the Declaration of Conformity (DoC) which is also included in the FDA Submission Package.

According to the FDA:

  1. Using the ASCA program “enhances the FDA’s confidence in test methods and results” included with the submission
  2. Using the ASCA program “decreases the need for additional information related to conformance with a standard” and “almost all non-ASCA submittals have delays for this reason”
  3. Using the ASCA program provides for “consistency, predictability, and efficiency in medical device reviews” which also helps to reduce delays

Premarket Submission Preparation with ASCA Testing: As specified by the FDA

  • Step 1: Identify ASCA Pilot standards to be cited
  • Step 2: Develop and agree on a test plan with an FDA-ASCA accredited test lab (see whitepaper #102)
  • Step 3: Plan submission elements (see whitepaper #103)
  • Step 4: Obtain Test Results & Summary ASCA Test Report from the test lab
  • Step 5: Prepare the FDA Submission

CertifiGroup – the 1st FDA-ASCA Accredited Test Lab!

CertifiGroup can provided compliance design guidance during product development,
including gap analysis, design reviews, and preliminary reviews.
We can provide UL, CSA, & CE/International Certifications.
We can assist you with all steps in the FDA Premarket Submission Process.

Experts in UL, CSA, CE, & International Regulatory Compliance

©2014-2020 CertifiGroup – complete copies of this document may be freely distributed

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