Your Device Doesn’t Qualify For An FDA Export Certificate? You Might Get A Non-Export Certificate
The agency has issued a notice explaining how products that do not qualify for an export certificate may still get a Certificate for Device Not Exported when marketing outside the US.
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FDA Issues Final Export Certificate Guidance, Explains What To Do If Your Firm Is Turned Down For One
An 8-page final guidance from the US agency lays bare reasons why it would deny an export certificate to a company. It also explains how a firm can appeal if it is turned down for a certificate. The guidance was developed because the FDA Reauthorization Act of 2017 – FDARA – required the agency to provide a rationale when it turns down a request for a Certificate to Foreign Government (CFG), including listing any specific grounds for a finding of noncompliance.
The document from the Medical Device Innovation Consortium aggregates external data sources, various statistical methods and lays out other considerations for sponsors to help speed up and bolster a premarket product application to the US FDA.
A top executive at the Swedish company spoke with Medtech Insight about how the mobility and data reliability of 5G cellular technology will change how medtech manufacturers design their products.