Insights & News

All About About ASCA

February 17, 2022
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Compliance & Regulatory: MedTech
Guidelines & Standards
Want to learn the ins and outs of the FDA’s ASCA Pilot Program? Learn from an experienced MedTech CRO team.

The Ins and Outs and Everything You Need To Know About the FDA's Pilot Program

Want to learn more about ASCA, including what it is and how it offers opportunities to jump over some premarket regulatory hurdles efficiently and effectively?

Keep reading to get an overview and better understanding of the FDA’s ASCA Pilot Program.

What is ASCA?

Launching back in September of 2020, the ASCA pilot program’s main purpose is to increase the consistency and predictability in the FDA’s approach to assess conformance in medical device premarket reviews.

How does ASCA accomplish this?

Similar to the EU market and notified bodies, the FDA implemented ASCA to create a more uniform premarket testing option that applies agency expectations.

The ASCA Pilot Program allows the FDA to grant ASCA recognition to qualified accreditation bodies to accredit testing laboratories.

The accredited laboratories can then perform premarket testing for medical device companies.

Manufacturers that provide a declaration of conformity from an ASCA-accredited lab are expected to have a smoother review process, as the FDA does not intend to request additional information. 

Refer to FDA’s page of ASCA-recognized accreditation bodies and their respective scopes of recognition.

In addition, a list of all ASCA Accredited Laboratories can be found here.

Standards Included in the ASCA Pilot

The FDA has chosen the standards and tests that cover biocompatibility, basic safety, and essential performance series. 

In accordance with the MDUFA IV commitment letter, the ASCA Pilot includes both cross-cutting (horizontal) and device-specific (vertical) standards, which are of public health significance and provide the means for establishing acceptance criteria. 

For an outline of all the ASCA Pilot standards, refer to this link

Manufacturers’ Responsibilities in the ASCA Program:

As a manufacturer, using ASCA-accredited testing laboratories to perform your testing is left to your discretion.

Keep in mind that regardless of whether testing is performed by an ASCA-accredited testing laboratory or elsewhere, your responsibility and expectations remain the same. 

You are still required to provide the same rigors of testing regardless of ASCA lab accreditation.

You are also responsible for providing all relevant information in a premarket submission, such as how testing supports marketing authorization. 

To be eligible for the ASCA Pilot, the premarket submission should meet the following expectations:

  • The submission is a 510(k), De Novo, Premarket Approval, or Investigational Device Exemption 
  • It is not submitted under the 510(k) Third Party Review Program
  • Testing is performed by a testing laboratory that is ASCA-accredited at the time testing is conducted

Summary of Submission Documents

Roadmap to Premarket Approval for ASCA

There’s your overview of the ASCA Pilot Program.

ASCA is a great way to ensure your premarket tests are completed efficiently with minimum complications. If you work with your regulatory consultant to outline the tests, get buy-in from FDA, and then go to an ASCA-accredited lab, your pre-market submission should be smooth sailing.

If you need some more answers about ASCA, reach out to one of our experts at Proxima.

We’ll be happy to assist you in understanding ASCA accreditation and getting your ASCA-product to market.

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