During the week of Feb. 17-23, 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 Feb. 24 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Feb. 18-21 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 reached a settlement with the Center for Food Safety on deadlines for its Food Safety Modernization Act regulations, ending a contentious lawsuit in the U.S. Court of Appeals for the 9th Circuit. The agency had been operating under deadlines ordered by the Northern California U.S. District Court in 2013 that required all seven of FDA’s final rules implementing FSMA by June 30, 2015 (see 13062412). The agreement extends the deadlines, some by nearly a year, in return for FDA dropping its appeal.
The Food and Drug Administration issued its weekly Enforcement Report for Feb. 19 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration announced several new initiatives during Commissioner Margaret Hamburg’s recent trip to India, in a bid to build capacity and boost food and drug safety in the country. FDA is in the process of expanding its offices in India to include new staff, said an agency spokesman. During the trip, Hamburg also signed an agreement to work more closely with Indian food and drug regulators.
The Food and Drug Administration is proposing to reclassify shortwave diathermy devices (SWD) as Class II devices that do not require premarket approval, in an apparent change in tack on the level of regulation applied to the product. FDA had in 2012 proposed to confirm classification of shortwave diathermy devices in Class III, and would have required the filing of a premarket approval application or product development protocol before distribution. But in response to comments, FDA is now withdrawing its 2012 proposed rule (here), and is instead proposing to reclassify shortwave diathermy devices in Class II (here). The proposal would also rename the device to “nonthermal shortwave therapy (SWT)” devices. Comments are due May 21.
The Food and Drug Administration is asking for input by April 21 on the standards it should use to develop the electronic track and trace system for drug products required by the Drug Supply Chain Security Act. The November 2013 law requires an electronic interface track and trace interface between FDA and drug manufacturers, wholesalers, repackagers, and dispensers (including pharmacies) that would allow for the electronic exchange of product and transaction information to enable verification of the legitimacy of drug products and improved efficiency of recalls (see 13121725).
On Feb. 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 Feb. 12 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.