The Food and Drug Administration removed about 9 percent of medical device facility registrations from its database in March, Registrar Corp. said in a blog post. That’s likely because those approximately 2,551 establishments did not renew their registrations by Dec. 31, the annual deadline for facility registration renewal, the consultancy said. “When a registration is deactivated, so are the active listings associated with the registration. All propriety names and importers will be removed from the listings,” Registrar Corp. said. “Marketing a medical device in the U.S. without a valid registration and listing is a prohibited act and may result in costly detentions or refusals. Many facilities do not realize their registration is invalid until problems like these occur,” it said. “Facilities whose registrations have been removed will be required to reactivate their registration and device listings with FDA.”
The Food and Drug Administration is extending the period for comments on a proposal to move up enforcement dates for new rules on e-cigarettes and flavored cigars in response to concerns about their use among minors. In a draft guidance issued March 13, FDA said it intends to begin requiring pre-marketing approvals for certain e-cigarettes and flavored cigars before they are sold in the U.S. as of 30 days after the agency’s guidance is finalized (see 1903140023).
On April 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 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 issued its weekly Enforcement Report for April 3 that lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration and CBP signed an agreement April 4 to increase cooperation on preventing “illegal and harmful products” from entering the U.S. via ports of entry and international mail facilities, FDA said in a press release. “Thousands of illicit and dangerous products come from overseas each day, such as unapproved fentanyl products, counterfeit prescription drugs or fake over-the-counter products that look legitimate,” FDA Commissioner Scott Gottlieb said. Under the agreement, FDA and CBP “will expand how information is shared between the agencies to identify trends which can target future entries. This may include general data points on frequent countries of origin, as well as specific products and volumes of packages at each location,” the release said. They will also “enhance coordination around efforts to identify violative packages and develop new targeting and enforcement strategies at Ports of Entry,” FDA said.
On April 2 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 proposing to amend is standard for bottled water to lower the amount of fluoride that can be added to domestic and imported bottled water. FDA is proposing to set the limit at 0.7 milligrams per liter. The limit for imported bottled water is currently 0.8 mg/L. Comments on the proposal are due June 3.
On April 1 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: