The Food and Drug Administration issued its weekly Enforcement Report for July 18 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On July 17 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 said the Office of Management and Budget approved its survey of "Health Care Providers' Responses to Medical Device Labeling." The FDA submitted the proposed information collection to OMB March 8, it said. The approval expires July 31, 2015. A copy of the supporting statement for this information collection is at http://www.reginfo.gov/public/do/PRAMain. Further information: Daniel Gittleson, 301-796-5156 or Daniel.Gittleson@fda.hhs.gov.
During the week of July 9-16, 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:
On July 16 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 a final rule amending the food additive regulations to no longer provide for the use of polycarbonate (PC) resins in infant feeding bottles (baby bottles) and spill-proof cups, including their closures and lids, designed to help train babies and toddlers to drink from cups (sippy cups), effective Aug. 16. According to the underlying petition, baby bottles and sippy cups manufactured from PC resins are no longer being introduced into the U.S. market, and manufacturers of baby bottles and sippy cups have abandoned the use of PC resins in making these products. Objections and requests for hearings are due by Aug. 16.
On July 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 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 gave notice that it signed a memorandum of understanding with the Mexican Secretariat of Health entitled “The Safety and Sanitary Quality of Fresh and Frozen Molluscan Shellfish Exported from the United Mexican States to the United States of America.” The memorandum, which contains a few minor changes from the 2003 memorandum (extended by a 2008 exchange of letters) with the same subject and title, accepts Mexico as a participant in the U.S. National Shellfish Sanitation Program (NSSP) in exchange for compliance of the Mexican Shellfish Sanitation Program with the NSSP, among other things. The agreement went into effect June 28, and has a duration of 5 years.
On July 11 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: