A premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) will be required for pacemaker pulse generators and pacemaker programmers, said the Food and Drug Administration in two final rules.

On June 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The application form for the Food and Drug Administration’s Secure Supply Chain (SSC) pilot program was submitted for the Office of Management and Budget approval, it said, as well as forms for modification of the application, responses to terminations of participation in the program, and recordkeeping requirements. Comments on the proposed information collection are due to the Office of Management and Budget by July 20.

On June 18 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 June 4-10, 2012, 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 June 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On June 14 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 June 13 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

All fresh, frozen, canned, and processed oysters, clams, mussels, and whole and roe-on scallops (molluscan shellfish) from Korea that have entered the U.S. should be removed from sale or service, said the Food and Drug Administration. This includes molluscan shellfish from Korea that entered the U.S. prior to May 1, when the FDA removed such products from the Interstate Certified Shellfish Shippers List (ICSSL), and that which may have inadvertently entered the country after that date, it said. According to FDA, These products and any products made with them may have been exposed to human fecal waste and are potentially contaminated with norovirus.

On June 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: