The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has announced the launch of a new electronic submission process for requesting export certificates for products it regulates, calling it a "win" for both the agency and industry.
In 1996, Congress passed the FDA Export Reform and Enhancement Act (FDERA) of 1996. The law was intended to clean up the reputations of medical device manufacturers and US exports by requiring all products being exported to meet certain requirements, either in the US, the recipient country or both.
The Certificates of Exportability (COE) established by the law allow companies to-as the name implies-export their products for sale and use in other countries. Depending upon which export pathway is sought, the certificates can mean different things to different entities.
For example, FDA does not restrict the export or sale of any medical device approved or cleared by it. Other countries, however, may require that the company obtain a certificate of export before allowing the product into their country, known as a Certificate for Foreign Government (CFG).
Unapproved devices, however, fall under the regulations of Section 801-802 of the Federal Food, Drug and Cosmetic Act (FD&C Act), section 801(e)(1) which requires companies to certify that a device:
- meets the specifications of a foreign purchaser
- is not in conflict with the importing country's laws
- is labeled "intended for export only"
- is not re-sold in the US
The devices may also need to meet other requirements under 801(e)(2) of the FD&C Act if they would be considered high risk (requiring a premarket approval application, or PMA), would not meet performance standards under Section 514 of the FD&C Act, are still undergoing clinical investigations, or are banned from the US market for reasons of safety.
Alternately, devices may also meet export requirements of Section 802, which requires exporters to meet the requirements of 801(1)(e) as well as all US standards for Quality System Regulations (QSRs) and standards such that it is not adulterated in any way (with the exception of lacking approval).
Depending on the medical device and its intended use, FDA can give out any number of export certificates:
- "The 'Non-clinical Research Use Only Certificate' is for the export of a product, material, or component, for non-clinical research use only, that is not intended for human use and which may be marketed in, and legally exported from, the United States under the FD&C Act. These non-clinical research use only materials will be labeled in accordance with 21 CFR 809.10(c)(2) or 21 CFR 312.160, as appropriate, and exported as they are presently being sold or offered for sale in the United States."
- "The 'Certificate to Foreign Government' is for the export of human drugs and biologics, animal drugs, and devices that can be legally marketed in the United States."
- "The 'Certificate of Exportability' is for the export of human drugs and biologics, animal drugs, and devices that cannot be legally marketed in the United States, but meet the requirements of sections 801(e) or 802 of the Act and may be legally exported."
A New System: 'eSubmitter'
While FDERA's rules may have been relatively novel in 1996, the submission system was-and remains-decidedly low-tech. At present, FDA only accepts requests for export certificates by mail.
All that is about to change, the agency wrote in a 22 January 2013 Federal Register notice.
"With electronic submissions, CDRH can more readily receive and process the export requests," the agency wrote. "The electronic process will help fulfill both the legislative and application time processing requirements set out by FDERA and the terms of clearance of the Office of Management and Budget approval (OMB control number 0910-0498) of the Form FDA 3613 series."
The system, known as the "eSubmitter process," is set to launch in two phases and will "complement"-not replace-the current paper-based submission process, FDA explained.
The first phase of the eSubmitter process will see CDRH's Export Certification Application and Tracking System (CECATS) available for use for export certificate request submissions for approved medical devices. Companies will be required to have an FDA Unified Registration and Listing System (FURLS) account to use the system, FDA said.
In the second stage of the process, FDA will allow all other export certification, notification and permit requests under FD&C Act Sections 801 and 802 to be made through the system.
Regulators said the system will be a "win" for industry and regulators, as it will allow both to submit and process requests more "efficiently and expeditiously." FDA is in the process of planning a series of webinars and other training activities on how to best use the system.
The system will reportedly be fully online in "early 2013," FDA wrote.