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Medical device manufacturers can be denied CFGs if FDA finds fault with standards and practices at their facilities. A CFG is a valuable document because once a device manufacturer has the paperwork, it opens up global markets by showing regulators the FDA has signed off on a device.
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FasterCures commends bipartisan support of FDA Reauthorization Act
FasterCures, a Center of the Milken Institute, commends the U.S. Senate on today’s strong, bipartisan support of the U.S. Food and Drug Administration (FDA) Reauthorization Act (FDARA) (H.R. 2430), which passed the Senate on a 94-1 vote, matching the U.S. House of Representatives’ passage on July 12, via voice vote. The bill will now be sent to the White House.
Beginning with the first public meetings back in July 2015, FasterCures has been an active participant in the stakeholder meetings for both the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Amendments (MDUFA). Throughout the process, FasterCures advocated for inclusion of provisions designed to enhance and advance FDA’s efforts to deepen and expand engagement with the patient community. We were very pleased to see those priorities reflected in the commitment letters for both MDUFA and PDUFA. In addition, FDARA – and PDUFA in particular – will provide critical resources to help FDA address the persistent challenge of recruiting and maintaining a workforce of highly trained scientists, clinicians, statisticians, and engineers. We look forward to continuing to work with FDA and other stakeholders to help implement and advance the provisions of this key legislation.
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