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Upon the regulatory approval of the device, Surmodics will be responsible for the manufacture and supply of clinical and commercial quantities of the product. Read More
Industry groups such as AdvaMed argued the caps would negatively impact manufacturers’ ability to pay for future R&D investments and job creation. Read More
Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Read More
The FDA worked with Baxter to help restore production as the previously existing shortages of IV saline and amino acids for injections had been exacerbated when Hurricane Maria struck. Read More
Sponsors of medical devices should submit a declaration of conformity, certifying compliance with the standards on a list maintained by CDRH. Read More