What in the World is the FDA’s Lab Accreditation Program – ASCA?

BiocompCHATibility

A NAMSA podcast series that addresses specific medical device evaluation scenarios and challenges.

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In this episode, our hosts are joined by Lisa Olson (NAMSA’s Vice President of North American Lab Services) to discuss the U.S. FDA’s new Accreditation Scheme for Conformity Assessment (ASCA). This pilot program, launched September 25, 2020 with a new guidance document, is designed to accredit laboratories for specific biocompatibility tests.

The U.S. FDA’s goal surrounding this new accreditation is to reduce the regulatory burden on the medical device industry through consensus of requirements for efficiency. This will also lead to decreased paperwork and timelines for certain regulatory submissions.

Although ASCA certification is not specific to the device manufacturer, unless they have an in-house laboratory, it is important for manufacturers to understand what ASCA is, its implementation and how important it may be when selecting a laboratory testing facility in the future.

“For the first time in medical device regulation history in the U.S., the U.S. FDA is going to accredit laboratories.” – Sheri Krajewski-Bibins

“If things were inconsistently reported by different laboratories, they [the U.S. FDA] had the responsibility to ask things. So if you can imagine them having to ask the same type of question on a basic cytotox assay for example, how much extra work that created because they [the U.S. FDA] can’t just assume it was done correctly?” – Lisa Olson

“They [the U.S. FDA] certainly won’t have to in all cases, review the complete testing report anymore.” – Don Pohl

“There’s the founding basis that you have a robust quality system, and that is the basis of the whole 17025 Certification. But now, the ASCA program ‘allows or requires’—however you want to look at it—you to get yourself [a lab] accredited to a certain test.” – Lisa Olson

“I could certainly see the benefit in trying to normalize that [training] across the industry.” – Don Pohl

“It’s an easier button, not an easy button, and manufacturers need to think about then do they go with labs that have no exposure to this program, simply because I think the Agency is going to use that [ASCA] in the background in how they are looking at data, no matter what it is.” – Lisa Olson

Discussion points include:

• When will the ASCA program be implemented?
• How does a laboratory qualify for the accreditation?
• How can manufactures capitalize on utilizing an ASCA laboratory for their biocompatibility testing?
• What are the potential challenges when implementing ASCA?

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

Also be sure to check out our Biocompatibility Strategy Navigator.