The Food and Drug Administration is requiring electronic reporting of adverse events related to medical devices, in a Feb. 14 final rule. Beginning Aug. 15, 2015, manufacturers and importers of medical devices must electronically submit medical device reports (MDRs) of deaths, serious injuries, and malfunctions, as well as supplemental or follow up reports, through one of two FDA systems. Only importer MDRs submitted directly to FDA are required in an electronic format; importer MDRs submitted to device manufacturers may still be in paper form. In conjunction with its final rule requiring electronic submission of MDRs, FDA posted a guidance containing questions and answers on the new requirements (here).
The Food and Drug Administration will hold three public meetings to discuss a recent proposal that would create new sanitation requirements for transporting food (see 14020301). The first two meetings will cover "both the focused mitigation strategies to protect food against international adulteration and sanitary transportation of human and animal food proposed rules" and will be held in Chicago and Anaheim, Calif., said the FDA. The third meeting, in College Park, Md., will "cover only the sanitary transport proposed rule during the proposed rule comment period," the agency said. The Chicago meeting is scheduled for Feb. 27, the California meeting for March 13, and the Maryland meeting for March 20, it said.
On Feb. 12 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 issued the Interstate Certified Shellfish Shippers List (ICSSL) for February. The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, South Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
On Feb. 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of Feb. 3-9, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
On Feb. 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Feb. 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 issued its weekly Enforcement Report for Feb. 5 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Feb. 5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: