The Food and Drug Administration posted a draft version of its strategic priorities for 2014-18. Just as it had in its 2011-15 strategic plan, FDA’s draft plan for the next four years emphasizes the importance of the globalization of supply chains for FDA-regulated products. It calls for cooperation between regulators worldwide. Other agency goals for the next four years include improved oversight of FDA-regulated products; improved and safer access to FDA-regulated products to benefit health; better informed patients, consumers and professionals; and improved internal organization and accountability. Comments on the draft strategic plan are due July 31, said FDA (here).
On June 30 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 23-29, 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 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 25 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 recently finalized a new guide to assist small businesses in compliance with the agency’s gluten labeling regulations. FDA’s rule on labeling food “gluten-free” only allows foods that do not contain gluten or that contain less than 20 ppm of gluten to make the claim (see 13080213). Compliance with the new requirements is required by Aug. 5, after which any foods that are mislabeled “gluten-free” will be considered by FDA to be misbranded.
The Food and Drug Administration finalized the remaining parts of a new guidance on the agency’s database for medical device “unique device identifiers” (UDIs). The guidance includes information for device labelers (in most instances, the device manufacturer) on how to use the Global Unique Device Identifier Database (GUDID), including how to establish GUDID accounts and begin initial submissions. It also contains examples of medical device labels that include UDIs. Labelers are required to submit data to GUDID if a device must be labeled with a UDI, FDA said in its UDI final rule. The agency had issued part of the guidance in early June (see 14061028). Comments on the guidance may be submitted at any time, said FDA in a concurrent Federal Register notice (here).
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:
The Food and Drug Administration intends to adopt a non-enforcement stance for controls on medical device data systems, it said in a draft guidance posted June 20 (here). Under the policy, if adopted, FDA would not “enforce compliance with the regulatory controls, including registration and listing, premarket review, postmarket reporting and quality system regulation for manufacturers of these types of devices,” it said. Comments on the draft guidance are due Aug. 25, according to a concurrent Federal Register notice (here).