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BiocompCHATibility Podcast
NAMSA Awarded ASCA Accreditation

NAMSA Awarded ASCA Accreditation

BiocompCHATibility vor 5 Jahren

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34:22

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

NAMSA is pleased to announce that the U.S. Food and Drug
Administration (FDA) granted the organization Accreditation
Scheme for Conformity Assessment (ASCA) status on July 23. The
ASCA Pilot Program, a first-of-its-kind assessment created by the
U.S. FDA, reduces the regulatory burden on medical device
manufacturers through consensus of biocompatibility testing
requirements for efficiency.

In this episode, our hosts are joined once again by Lisa Olson,
NAMSA’s Senior Vice President of Global Laboratory Operations to
discuss the importance of this accreditation and what it means to
NAMSA. But perhaps most importantly, what this status means for
manufacturers who choose to do their testing with ASCA accredited
laboratories.

“It’s the first time the FDA has done this for a
biocompatibility lab.” Sheri Krajewski

“I believe the FDA was really looking at the value of the
tests. There are certain tests like cytotoxicity that are
incredibly standardized. In essence, many labs are doing them the
same. The FDA did a great job of picking out the studies are well
established and many labs know how to do them and have
established protocolsfor them.” Lisa Olson

“NAMSA is accredited for biocompatibility testing and
people would say, aren’t you already? NAMSA has submitted
biocompatibility testing for many years. Yes, we have. The
difference here is the FDA has taken steps to pre-qualify certain
tests.” Sheri Krajewski

“There might be for ASCA studies limited deficiencies and
limited review time. Hopefully none (deficiencies) for these
(ASCA) studies.” Don Pohl

“What you really care about is the data. And, by having
these summary reports, you get rid of all the marketing part of
it and some of the ‘fluff’ and get a clean report of results. I
think it’s a great way to have both reviewers and labs focus on
the most important part.” Lisa Olson

Discussion points include:

What biocompatibility tests are included in ASCA
accreditation?

How can manufactures capitalize on utilizing an ASCA
laboratory for their biocompatibility testing?

What types of devices are disqualified from ASCA testing?

What are the potential challenges when implementing ASCA?

How do manufacturers “order” ASCA Testing? Is everything
ASCA?