MDMA (US Medical Device Manufacturers Association) asks FDA to re-think new export regulations
This article was originally published in Clinica
The US Medical Device Manufacturers Association (MDMA) intends to ask the FDA to withdraw a recently proposed regulation requiring substantial new paperwork and notification before companies can export unapproved devices. Stephen Northrup, the MDMA's executive director, says the proposal, which was published in the April 2 Federal Register, would undermine the FDA Export Reform and Enhancement Act of 1996.
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