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

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

BiocompCHATibility vor 5 Jahren

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Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

In this episode, our hosts are joined by Lisa Olson (NAMSA’s Vice
President, North American Lab Services) to discuss the U.S. FDA’s
new Accreditation Scheme for Conformity Assessment (ASCA). This
pilot program, launched September 24, 2020 with a new guidance
document, is designed to accredit laboratories for certain
biocompatibility tests, allowing for decreased paperwork and time
for certain regulatory submissions, among other things. Although
this is not specific to the device manufacturer unless they have
an in-house laboratory, it is important for manufacturers to
understand what ASCA is, how it is implemented 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, to allow 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 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 challenges with implementing ASCA?