- January 23, 2020
The first, built around the coordinating center of the National Evaluation System for health Technology, or NEST, aims to link data from sources such as clinical registries, electronic health records and billing claims as it works to build up the quality and usability of real-world evidence sources. While the NEST coordinating center was established as a governing organization in 2016, its new recognition as a full-fledged collaborative community follows on the strategic priorities outlined by the FDA’s Center for Devices and Radiological Health (CDRH). It aims to develop methodologies and standards for the collection of real-world data and its analysis.
“Part of our work assuring patients and health care professionals have timely and continued access to safe, effective and high-quality medical devices involves collaboration with diverse stakeholders,” CDRH Director Jeff Shuren said in an FDA statement. “We know we can achieve better outcomes in protecting and promoting public health when key stakeholder groups work together to achieve shared outcomes and solve shared problems,” Shuren added.
Meanwhile, the Ophthalmic Imaging Collaborative Community aims to identify best practices and innovation strategies in the field through a group of international stakeholders. This includes the use of natural language processing and other tech to help aid in the diagnosis, management and treatment of patients with eye diseases and other conditions. In both communities, the FDA said it will take on a participatory role without establishing or leading the collaborations. In addition, the communities are not intended to serve as official advisory boards to the Agency.
“We firmly believe in the opportunities offered by participating in collaborative communities, and we recognize that we serve the American public better when stakeholders in the medical device ecosystem, including the FDA, work together,” Shuren said. The FDA plans to join at least 10 collaborative communities such as these by the end of 2020. Additionally, the FDA announced a new pilot to increase the predictability of premarket device reviews. The Accreditation Scheme for Conformity Assessment (ACSA) program is a separate, FDA-run voluntary initiative aimed at producing a set of Agency-qualified research laboratories and consensus standards for safety and effectiveness testing.
In-house and independent labs may apply to the FDA to participate in the pilot, the Agency said. ASCA accreditation will be granted to qualified testers, which could then work with device manufacturers to support their premarket submissions to the Agency.
REFERENCE: Fierce BioTech; 20 SEP 2019; Conor Hale