Devices

ASCA Pilot Should Help Device Premarket Review: CDRH

CDRH Office of Strategic Partnerships and Technology Innovation senior policy analyst Stacy Cho says the Accreditation Scheme for Community Assessment (ASCA) pilot program being developed by CDRH should improve efficiency of the premarket review process by building confidence in a declaration of conformity through utilization of accredited testing laboratories. She spoke at a 10/28 Center Webinar on the agency’s 9/23 draft guidance on the pilot program.

Cho said that during MDUFA 4 discussions, FDA and industry agreed to establish a conformity assessment accreditation scheme for testing laboratories that evaluate medical devices according to certain agency standards. She noted that the draft guidance was issued for public comment and the pilot will not start until the guidance is finalized.

The pilot program is intended to capitalize on the relevance of consensus standards and device development and regulatory review and the existence of a well-established international conformity assessment structure.

FDA, which has not had a prior relationship with testing laboratories, Cho said, wants to open a relationship through accreditation bodies.

She emphasized that the pilot will be a voluntary program for all external stakeholders, meaning the accreditation bodies, testing laboratories, and device manufacturers. In the pilot, she says, FDA intends to (1) leverage the existing relationships between accreditation bodies and testing laboratories; (2) rely on recognized accreditation bodies to accredit testing laboratories using a specific conformity assessment scheme outlined in the guidance; and (3) not question the validity of methods and outcomes from ASCA-accredited testing laboratories except in specified instances.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome