James A. Boiani, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “FDA Takes Steps Toward Creating Lab Accreditation System for Evaluating Medical Devices,” by David Lim. (Read the full version – subscription required.)
Following is an excerpt:
James Boiani, attorney at Epstein Becker & Green, believes the new ASCA program could help solve the challenges identified by FDA and make reviews go more smoothly.
“FDA could still ask questions about testing that was conducted, request and dig through study reports, resulting in various discussions about whether the standards [were] met or not, whether there were deviations from the standard, etc. Through this new system, if FDA has agreed to accept test results up front from an accredited testing laboratory applicants won’t run into those kinds of issues and reviews should go more smoothly for FDA and the applicant,” Boiani told IHP.
