On March 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 20 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 will allow more time for comments on two proposals related to the Food Safety Modernization Act, it said on March 19. FDA said it will extend until June 30 the period for comments on its Food Safety Modernization Act (FSMA) proposed rule on the intentional adulteration of food (see 13122017). It is also extending until May 22 the period for comments on proposed criteria for designation of high-risk foods that will be subject to heightened recordkeeping requirements (see 14020318). The agency said the extensions will be formally announced soon in the Federal Register.
The Food and Drug Administration threatened to refuse admission to fish products from three New York importers, in separate warning letters sent in early March. The agency said fish products from Han Sung Sikpoom Trading Co., Hong Lee Trading Inc., and Russian Products, Inc. failed to meet seafood hazard analysis and critical control point standards (HACCP). FDA said it sampled fish products imported by each company, and refused admission because of HACCP violations.
On March 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 issued its weekly Enforcement Report for March 19 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On March 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 March 10-16, 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 and/or surveillance of:
The Food and Drug Administration is announcing in a Federal Register notice (here) a new draft question and answers document on the Humanitarian Device Exemption (HDE) from normal registration requirements for medical devices (here). Under the exemption, Humanitarian Use Devices (HUD) intended for the treatment or diagnosis of a condition that affects less than 4,000 people in the U.S. per year do not have to meet the effectiveness requirements of normal pre-market approval (PMA) applications. Devices marketed under the Humanitarian Device Exemption cannot in most cases be sold for profit. Comments on the draft guidance are due by June 16.
On March 14 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: