The Food and Drug Administration is formally reclassifying some devices used for detection of tuberculosis as Class II devices that do not require premarket approval, in a final order that takes effect June 30. "Nucleic acid-based systems for mycobacterium tuberculosis complex in respiratory specimens" had been classified in Class III, and required the filing of a premarket approval application before distribution. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to testing and labeling, and will not be exempt from premarket notification requirements.
On May 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 29 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 tightening controls on ultraviolet tanning lamps, reclassifying the devices from class I into class II and requiring a special "black box" warning. The reclassification makes the tanning lamps subject to premarket notification requirements, and imposes special controls that FDA deemed necessary for safe use. The final order also renames the devices "sunlamp products," but includes language that clarifies the requirements apply to both sunlamp products and UV lamps intended for use in sunlamp products.
The Food and Drug Administration issued a new guidance for industry on agency policies and procedures related to expedited drug development and review programs. The guidance, titled ‘‘Expedited Programs for Serious Conditions—Drugs and Biologics” (here), provides a “single resource” for information on FDA emergency expedited review, including fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation, said FDA. It addresses the applicability of expedited programs to rare diseases, clarification on available therapy, and flexibility in manufacturing and product quality, among other things.
The Food and Drug Administration issued its weekly Enforcement Report for May 28 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 is formally reclassifying pancreatic drainage stent and delivery systems as Class II devices that do not require premarket approval, in an order that codifies a reclassification that took effect Dec. 18. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. But FDA reclassified them in response to a request from Xlumena, Inc. related to the AXIOS Stent and Delivery System. 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. pancreatic drainage systems will not be exempt from premarket notification requirements.
On May 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 27 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 May 19-25, 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: