California Healthcare Institute (CHI) Submits Comments to FDA on 510(k) Reform Initiatives

LA JOLLA, Calif.--(BUSINESS WIRE)--CHI-California Healthcare Institute today submitted formal comments to the U.S. Food and Drug Administration (FDA) regarding the Center for Devices and Radiological Health 510(k) Working Group Preliminary Report and Recommendations, which could transform the 510(k) regulatory process for new medical devices, greatly affecting innovation and public health in California. CHI is a non-profit public policy research organization, representing leading California academic institutions, biotechnology, medical device, diagnostics and pharmaceutical firms.
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