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FDA Seeks Comments on Export Certificate Requirements
November 24, 2017 |FDA

The Food and Drug Administration seeks comments by Jan. 26, 2018, on export certificate requirements for FDA-regulated products, it said. FDA has developed four different types of certificates it issues for exports of food, animal feed, pharmaceuticals, biologics and devices that are either legally marketed in the U.S. or not legally marketed but acceptable to the importing country: (1) Certificates to Foreign Governments, (2) Certificates of Exportability, (3) Certificates of a Pharmaceutical Product and (4) Non-Clinical Research Use Only Certificates. Comments should address whether the information collections are necessary, whether FDA’s estimates of the burden of the information collections are accurate, ways to enhance the information collected and ways to minimize the burden of the information collections, FDA said.

FDA Issues Small Business Guidance on Sanitary Transportation Requirements for Food
November 22, 2017 |FDA

The Food and Drug Administration on Nov. 21 released a guidance document intended to help small businesses comply with new regulations on the sanitary transportation of food. The agency’s small entity compliance guide includes information on who is subject to the new regulations, issued in 2016 pursuant to the Food Safety Modernization Act (see 1604050023), as well as when compliance is required and what activities are required to comply. The guide also includes information on training and recordkeeping requirements and waivers from the sanitary transportation rules. Compliance with the new requirements is required by April 6, 2018, for small businesses, and has been required since April 2017 for other businesses that do not qualify for exemptions. Under the regulations, all shippers, carriers, loaders and receivers are responsible for ensuring that transportation operations comply with FDA regulations through the use of competent supervisory personnel; segregation and isolation to prevent contamination; and temperature controls.

FDA Issues Guidance on UDI Direct Marking Requirements for Medical Devices
November 22, 2017 |FDA

The Food and Drug Administration on Nov. 17 issued a new guidance document on direct marking requirements for medical devices. The new guidance includes information on when direct placement of unique device identifiers is required, what devices require direct marking and what methods are acceptable. The guidance document also discusses the effect of adding direct marking on device submissions to FDA and user fee requirements. Under a final rule issued in 2013 (see 13092020), direct marking of UDIs onto devices, as opposed to on labels and packaging, is required for devices intended for more than one use that must be reprocessed between uses.