The Food and Drug Administration is backtracking on a proposal to reclassify into class III and require premarket approval for cranial electrotherapy devices. The agency is withdrawing a proposed order from April to reclassify the devices, which are used to treat insomnia, depression and anxiety (see 13040420). Instead, it plans to issue a proposed order to reclassify cranial electrotherapy devices into class II, which means they may require premarket notification but not premarket approval.
The Food and Drug Administration on June 11 finalized parts of a new guidance on its database for medical device unique identifiers. The guidance includes information for device labelers (in most instances, the device manufacturer) on how to use the Global Unique Device Identifier Database (GUDID), including how to establish GUDID accounts and begin initial submissions. Labelers are required to submit data to GUDID if a device must be labeled with a Unique Device Identifier (UDI), FDA said in its final regulations on the subject. Many parts of FDA’s guidance on GUDID have not been finalized, and have been left blank until they are, said FDA in a concurrent Federal Register notice (here).
On June 9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration posted a draft guidance on identification of suspect product in pharmaceutical supply chains and subsequent notifications to FDA, as required by the Drug Supply Chain Security Act. Beginning on Jan. 1, 2015, “trading partners” as defined by the 2013 law must notify FDA when they come across “illegitimate product.” The draft guidance includes scenarios that should raise red flags for supply chain participants, as well as due diligence activities that should be undertaken and the procedure for submitting and terminating notifications when illegitimate product is found. Comments on the draft guidance are due Aug. 11, according to a concurrent Federal Register notice (here).
On June 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration is adopting as final its interim regulations that established current good manufacturing practice (CGMP) requirements for infant formula. FDA is making some changes to the interim regulations, including provisions for an exemption from infant formula testing if the manufacturer or importer can show the new formula wouldn’t differ from a similar formula that’s already on the market. Manufacturers are required to comply with the new regulations by Sept. 8, 2014, except for some provisions which are getting a grace period until Nov. 12, 2015.
The Food and Drug Administration recently began increased sampling of imported and domestic whole pit avocados as part of an agency inquiry into salmonella and listeria contamination in guacamole, according to a notice dated May 23 that was posted by OHL and later confirmed by FDA to be authentic. The notice says sampling “is targeted to begin” in May 2014, and “will continue through” May 2015. FDA says “the majority” of the sampling will take place outside of the normal import clearance process, and it will release shipments for distribution by the importer before it gets the results of the sampling.
On June 5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration threatened to refuse imports from a Sri Lanka seafood processor unless violations of multiple regulations are corrected. In a warning letter dated May 15, the agency told AMK Food Export (Pvt) Ltd. that an FDA inspection of its Homagama facility allegedly turned up violations of emergency permit control, thermally processed low-acid food, seafood hazard analysis and critical control point, and current good manufacturing practice regulations. Unless the violations are corrected, FDA says it may place any violative AMK products on import alert and refuse admission under detention without physical examination. FDA also told AMK that it may charge the company’s U.S. agent fees for costs the agency incurs during any reinspection.
On June 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: