TOLEDO, Ohio--(BUSINESS WIRE)--NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today that the U.S. Food and Drug Administration (FDA) has granted the organization Accreditation Scheme for Conformity Assessment (ASCA) status. The ASCA Pilot Program, a first-of-its-kind conformity assessment program created by the U.S. FDA, reduces the regulatory burden on medical device manufacturers through consensus of biocompatibility testing requirements for efficiency.
Initiated as part of the enactment of the Medical Device User Fee Amendments of 2017 (MDUFA IV), the ASCA Pilot Program clears the first hurdle in the medical device premarket regulatory process for manufacturers submitting for clearance or approval to the FDA’s Centers for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER). NAMSA, now the first and only ASCA-accredited biocompatibility laboratory in the United States, will help medical device manufacturers accelerate development timelines and streamline FDA review timelines through the elimination of testing redundancies, creation of biocompatibility efficiencies and the delivery of trusted test reports.
Founded in 1967, NAMSA was the first independent company in the world to focus solely on testing medical device materials for safety. Today, the organization conducts over 100,000 tests annually to assist medical device innovators meet global testing requirements, mitigate biological risks and ensure medical device safety for end users.
“Through our work with thousands of medical device manufacturers, we recognize that there are variations in test methods, parameters and report styles that can often contribute to delays in the FDA review process,” commented Lisa Olson, Senior Vice President, Global Laboratory Operations. “Based on the new ASCA requirements and guidance documents, testing disparities may now be eliminated to streamline development timelines through accurate, trusted, ASCA-accredited biocompatibility testing programs,” she concluded.
NAMSA was audited by third party organization, American National Standards Institute (ANSI), with submission of ASCA application on February 8, 2021 and U.S. FDA accreditation granted on July 23, 2021.
To learn more about NAMSA’s ASCA-certified biocompatibility testing services and solutions, please click here.
Helping medical device Sponsors improve healthcare since 1967, NAMSA is the only 100% medical device-focused, full continuum Contract Research Organization (CRO). Driven by our global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, we are the industry’s premier, trusted partner for successful development and commercialization outcomes. Web: namsa.com