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Regulatory Focus™ > News Articles > 10 > AdvaMed Criticizes FDA Draft Guidance on Export Certificates

AdvaMed Criticizes FDA Draft Guidance on Export Certificates

Posted 22 October 2018 | By Zachary Brennan 

AdvaMed Criticizes FDA Draft Guidance on Export Certificates

Medical device industry group AdvaMed criticized recent draft guidance on export certificates for devices, saying it suffers from “inaccuracies and omissions that FDA must correct.”

The seven-page draft guidance, released in August, explains the process by which companies can be denied a Certificate to Foreign Government (CFG) for a device and what to do if one receives a denial.

AdvaMed VP Steve Silverman writes that the draft contradicts express congressional intent “in refusing to issue CFGs for devices exported from outside the US.” In addition, the trade group cites critical gaps in the draft’s process for handling denials of CFGs.

In breaking down what’s wrong with the guidance, AdvaMed starts with the scope of the guidance, noting that FDA proposes to exclude from eligibility all devices that are not exported from the US.

“FDA’s position is plainly incorrect,” AdvaMed says. “And excluding all such devices from CFG eligibility would be arbitrary and capricious, inconsistent with current agency policy, and disregard Congress’s undisputed intent in FDARA section 704.”

Instead, FDARA offers some structure for explaining and reviewing CFG denials, AdvaMed says, and it “emphasizes that this structure applies to device establishments ‘regardless of whether’ the devices are exported from the US.”

“FDA engaged directly with Congress and other stakeholders in negotiating section 704, and FDA knew that this provision was intended to confirm that foreign establishments in good standing with FDA could obtain CFGs. So, it is particularly puzzling that FDA now excludes CFGs for OUS facilities since it was FDA that suggested the inspection criteria that Congress included for these establishments. FDA presumably offered these criteria in good faith, rather than to saddle the FDCA with language that FDA considers superfluous,” Silverman writes.

AdvaMed also takes issue with a section of the draft guidance on FDA’s process for denials of CFG requests, saying it violates FDARA section 704.


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