How Will the US FDA’s ASCA Pilot Program Help You?

Steve Hayes

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Steve Hayes

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Steve Hayes has over 30 years of experience in the product approvals industry and serves on numerous national and international standards committees.

What is the ASCA Pilot Program?

The Accreditation Scheme for Conformity Assessment (ASCA) program is a voluntary pilot program intended to improve the efficiency of pre-market testing and certification of medical devices. It also provides manufacturers with confidence that their product is being tested by experts in their given field since the FDA has assessed this subset of test laboratories. 

The program provides accredited, independent testing laboratories with the approval to assess medical devices for compliance with FDA-recognized standards. The FDA assumes a level of trust for the ASCA-approved testing laboratory and, aside from regular quality audits, test results will not require further review to receive FDA approval, saving significant time in the process.

How will the ASCA Pilot Program benefit you, the manufacturer?

Medical device manufacturers who choose an FDA ASCA-accredited laboratory to conduct their test for pre-market submission can then use these results in their declaration of conformity (DOC). 

The FDA has stated, “testing performed by an ASCA-accredited testing laboratory can be used to support a pre-market submission for any device if the testing was conducted using an FDA-recognized consensus standard and test method eligible for inclusion in the ASCA Pilot and in accordance with the ASCA program specifications for that standard.” 

This means that the chance of FDA reviewers asking for additional review or repeat testing is very low with an ASCA-accredited test partner. The testing and review process is streamlined with an ASCA-accredited laboratory, providing consistency and predictability in your testing and review process. 

Testing with an FDA ASCA-accredited laboratory makes your testing process significantly more efficient, allowing you to shuttle a safe, reliable and certified medical device to market quickly.

What is the process?

1. Medical device manufacturers choose their ASCA-accredited laboratory for testing.

2. The laboratory then conducts required testing and provides the manufacturer with the information outlined in the applicable ASCA program.

3. The manufacturer then integrates the ASCA test report in their DOC for pre-market submission to the FDA. 

4. The FDA then assesses the application in line with their pre-market review

How can Element help?

The initial list of ASCA-accredited testing laboratories was published on April 12, 2021, and we are pleased to say that Element is among them. 

Our accredited laboratories perform electromagnetic compatibility (EMC) and wireless coexistence testing from five strategically positioned locations across the US. Element’s accreditation covers all medical products governed by FDA regulations. We also help with the preparation of the test plan, an essential part of preparing for testing to ensure the right aspects are being tested and monitored correctly and in line with referenced standards.

Element has a strong reputation for EMC, wireless coexistence and safety testing, and medical devices certification, so combining these two capabilities, along with our broad geographical footprint, translates to better lead times. As we can combine medical device testing with all the other regulatory testing, such as FCC and CE marking and international certification schemes like IECEE CB, we can further shorten our customers’ time to market.

To learn more about our ASCA accreditation and medical device testing services, or to begin the testing process, please contact us today.

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