Nelson Labs said it is now an ASCA-accredited testing laboratory by FDA within the category of biocompatibility.
ASCA is an accreditation structure of the FDA, wherein accreditation bodies recognized by ASCA can grant ASCA accreditation to qualified testing laboratories based on their conformity to international standards (ISO/IEC 17025:2017) and FDA-identified specifications within the ASCA program.
This accreditation gives Nelson Labs an added measure of credibility with FDA, as the applicable protocols, training requirements, and final report formats have met acceptable standards recognized by FDA. The accreditation should save FDA reviewers time and effort, streamlining a part of the review process often bogged down by questions.
“An ASCA accreditation is recognition of Nelson Lab’s quality of FDA submissions containing biocompatibility-testing results,” said Thor Rollins, Vice President, and Global Market Segment Leader of Medical Devices at Nelson Labs. Rollins adds, “Consistency and reliability with test procedures and reports will help increase speed of acceptance and reduce any questions or concerns about biocompatibility testing.”
Nelson Labs said for medical device manufacturers who rely on it for biocompatibility testing, the ASCA accreditation should help to accelerate the speed to market for safe, quality technology.