The Food and Drug Administration announced the availability of a draft guidance entitled “Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories,” as provided by Section 102 of the Food Safety Modernization Act (FSMA). FSMA amended Section 415 of the Food, Drug and Cosmetic Act, which requires both domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with the FDA.
On Aug. 13 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 Aug. 6-12, 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 of:
The Food and Drug Administration (FDA) issued the August Interstate Certified Shellfish Shippers List (ICSSL). 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, Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
On Aug. 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 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The Food and Drug Administration is asking for comments on a draft guidance entitled “Refuse to Accept Policy for 510(k)s,” which explains the procedures and criteria FDA intends to use in determining whether a premarket notification (510(k)) submission is administratively complete and should be accepted for substantive review. FDA’s draft guidance is not in effect, but once it’s final it will be applicable to 510(k)s reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). Comments should be submitted by Sept. 27 to ensure consideration before the final version of this guidance is published.
On Aug. 8 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 Aug. 8 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration is seeking nominations for a nonvoting industry representative(s) on the Pediatric Advisory Committee to the Office of the Commissioner. Nominations are due by Sept. 10. Organizations interested in assisting FDA in selecting the committee members should also notify FDA by Sept. 10.