During the week of June 30 - July 6, 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 July 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 3 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 announced a new agreement aimed at improving regulatory cooperation and harmonization with the regional public health organization for the Americas. The cooperative agreement follows an earlier four-year agreement between FDA and the Pan American Health Organization that was signed in September 2010. Through the new agreement, FDA will provide $2 million to the Pan American Health Organization for use toward improving regulatory harmonization and building capacity. The agreement is set to last five years.
The Food and Drug Administration is classifying transcranial magnetic stimulators for headache treatment as Class II devices that do not require premarket approval, in an order that codifies a reclassification that took effect Dec.13, 2013. FDA is classifying the devices in response to a request from eNeura Therapeutics related to the Neuralieve Cerena system. As Class II devices, transcranial magnetic stimulators will not need FDA pro-approval, but they will still be subject to certain extra "special controls" related to testing and labeling. They will not be exempt from premarket notification requirements.
The Food and Drug Administration issued its weekly Enforcement Report for July 2 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On July 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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 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.
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.