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:
The Food and Drug Administration issued a guidance document on its unique device identifier (UDI) system for medical devices (here). The guidance contains information on effective dates, label contents, and which products are subject to the new requirements. The UDI system will begin taking effect Sept. 24 for Class III devices.
The Food and Drug Administration issued its weekly Enforcement Report for June 24 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.
On June 25 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 24 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 16-22, 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 June 23 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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 Food and Drug Administration is adding selenium to the list of nutrients required in infant formula, in a final rule that takes effect June 22, 2016 (here). The agency’s final rule also sets minimum and maximum levels of selenium in infant formula. Written objections are due July 23.