US Trading Company is recalling batch of chili powder imported from Thailand because of the presence of Salmonella, said the Food and Drug Administration March 13. The chili powder comes in a 6.3 ounce clear plastic tub. The bar code 7 21557 53317 8 is printed on the front of the tub. The code 359XP is affixed to the bottom of the container. FDA said it found the problem in a lot of chili powder during routine sampling. Production and distribution of the product have been suspended while FDA, the California Department of Public Health, and US Trading continue the investigation, it said.
The Food and Drug Administration announced the reclassification of colon capsule imaging systems as Class II medical devices subject to special controls. Colon capsule imaging systems were previously classified in Class III and required premarket approval. The reclassification took effect Jan. 29; FDA’s final order merely codifies it into regulation. Although they will no longer need FDA approval, the devices will still be subject to premarket notification requirements, as well as certain extra "special controls" related to testing, biocompatibility, and labeling.
The Food and Drug Administration is formally reclassifying intravascular administration set air removal systems as Class II devices that do not require premarket approval, in an order that codifies a reclassification that took effect March 4. 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 Anesthesia Safety Products, LLC related to the AirPurge System. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to design characteristics, testing, biocompatibility, and labeling. Air removal systems will not be exempt from premarket notification requirements.
The Food and Drug Administration issued its weekly Enforcement Report for May 14 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’s Center for Tobacco Products is moving a few miles down the road from Rockville, Maryland. to the agency’s main White Oak campus in Silver Spring. FDA says the move will begin around June 6, and will take about three weeks. All physical correspondence with the Center for Tobacco Products should be addressed to the new address beginning on June 6. More information is available (here).
The Food and Drug Administration is announcing updates to its list of standards FDA recognizes for use in premarket reviews of medical devices (FDA recognized consensus standards). This publication, titled "Modifications to the List of Recognized Standards, Recognition List Number: 035," will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices, said FDA.
On May 13 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 will expand cooperation with European regulators on pharmaceuticals, in an initiative announced in May 12 by Howard Sklamberg. FDA will be deploying a “dedicated FDA team to work with our European counterparts on a host of issues,” he said. The team will include officials from FDA’s Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, and Office of Global Regulatory Operations and Policy. “Through this initiative, and in cooperation with the European Commission (EC) and the European Medicines Agency (EMA), FDA will aim to deepen our reliance on trusted regulators outside of the U.S. who provide equivalent public safety and quality protection,” said Sklamberg.
On May 12 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 posted a new draft guidance on the use of national and international voluntary consensus standards in the preparation and evaluation of premarket submissions for medical devices. The draft guidance also proposes two changes in policy, the first being that declarations of conformity would no longer be used when the submitter deviates from an FDA standard, and the second being that promissory statements indicating future compliance with a consensus standard would no longer be used. Comments on the draft guidance are due Aug. 11, said FDA in a concurrent Federal Register notice (here).