On July 1 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 formally reclassifying transcutaneous electrical nerve stimulators as Class II devices that do not require premarket approval, in an order that codifies a reclassification that took effect March 11. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. FDA reclassified them in response to a request from STX-Med related to the Cefaly Device. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to testing, biocompatibility, and labeling. The devices will not be exempt from premarket notification requirements.
The Food and Drug Administration is reclassifying nonpowered lower extremity pressure wraps as Class I devices that are not subject to premarket approval or notification requirements. The order codifies a reclassification that took effect Dec. 30, 2013, said FDA. The devices remain subject to prescription-use restrictions, it said.
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:
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 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.
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:
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.