The Food and Drug Administration on Nov. 26 issued a draft guidance on standards for data exchange under the Drug Supply Chain Security Act (here). The year-old law requires an interface between FDA and drug manufacturers, wholesalers, repackagers, and dispensers 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). Comments on the proposed standards are due by Jan. 27.
During the week of Nov. 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 Nov. 24 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 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 issued new guidance on Nov. 24 for labeling of certain medical devices (here). The agency is now recommending manufacturers “prominently include” contraindications and boxed warnings on labeling of laparoscopic power morcellators (here), in light of the risk that the devices could spread cancer in some situations.
On Nov. 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 issued its weekly Enforcement Report for Nov. 19 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 Nov. 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 warned an Indian food exporter that it may be put on import alert because of violations of emergency permit control and acidified food regulations (here). In a letter dated Nov. 12, the agency told KIZ Foods Limited that an FDA investigator visited the company’s Bhavnagar, India facility and found a multitude of violations. Unless the violations are corrected, FDA may place food produced at the facility on detention without physical examination, it said.
The Food and Drug Administration on Nov. 19 announced it is postponing the date it will require unique device identifiers (UDIs) on certain single-use implantable medical devices that must be sterilized before use (here). Under a final rule issued in September 2013 (see 13092020), implantable devices don’t necessarily have to be directly marked with a UDI, but the UDI must be available at the time they are used, said FDA. This can be difficult for implantable devices that must be sterilized, because they have to be separated from their labeling before the additional step. Although Class I implantable devices had to comply by Sept. 24, 2014, and compliance was required for all other implantable devices by Sept. 24, 2015, FDA is now giving companies until Sept. 24, 2016 to meet UDI labeling requirements for certain devices listed in the agency’s notice. However, the effective date of the requirement to submit information to the Global Unique Device Identification Database (GUDID) is unchanged, said FDA.