A premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) will be required for cardiovascular permanent pacemaker electrodes, said the Food and Drug Administration in a final rule.

On July 2 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 25 - July 1, 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:

A draft guidance is now available on labeling requirements for certain over-the-counter internal analgesic, antipyretic, and antirheumatic drug products that contain acetaminophen, said the Food and Drug Administration (FDA). The draft guidance, entitled “Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use -- Labeling for Products That Contain Acetaminophen,” is intended to inform manufacturers of the circumstances in which the FDA intends to enforce the liver warning requirement for such products. To ensure consideration of comments before the final version of this guidance is released, comments should be submitted by Sept. 4, the FDA said. The draft guidance is available here.

The Food and Drug Administration (FDA) proposed that most medical devices distributed in the U.S. carry a unique device identifier, or UDI, acting in response to congressional legislation. It said a UDI system could improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA is seeking comment on the proposal for 120 days. The FDA is proposing a risk-based, phased-in approach to implementation, focusing on the highest-risk medical devices first and exempting low-risk devices from some or all of the requirements. The FDA is proposing to exempt over-the-counter devices sold at retail; these devices generally have UPC codes in place.

The Food and Drug Administration will not allow foreign manufacturers outside of Mexico and Canada to participate in its Secure Supply Chain pilot program, ITT has learned. Although the FDA’s July 20 Federal Register notice did not explicitly say that only U.S., Canadian and Mexican manufacturers could take part, Sara Clark-Lynn of the FDA Office of Public Affairs confirmed that only C-TPAT Tier II and III members are eligible for the pilot program, and acknowledged that “only foreign manufacturers located in Canada and Mexico are eligible to become C-TPAT members.”

On June 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On June 27 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 27 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

On June 26 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: