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Federal court orders Minnesota sprout and noodle company to cease operations due to unsanitary conditions

On July 15, 2016, the U.S. District Court for the District of Minnesota entered a consent decree of permanent injunction between the United States and Kwong Tung Foods, Inc., doing business... read more

FDA approves first intraocular lens with extended range of vision for cataract patients

The U.S. Food and Drug Administration today approved the first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual... read more

FDA approves new medication for dry eye disease

The U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra is the first... read more

FDA approves first MRI-guided focused ultrasound device to treat essential tremor

The U.S. Food and Drug Administration today approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro uses magnetic... read more

Food and Drug Adminstration (FDA): CDRHNew

Evaluation of Automatic Class III Designation (De Novo) Classification Order (DEN160003 added)

Evaluation of Automatic Class III Designation (De Novo) Classification Order (DEN160003 added)

Class I Medical Device Recall: Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) Recalls Flush Angiographic Catheter Due to Tip Separation

Stryker Sustainability Solutions is recalling the device due to reports of separation of the tip of the catheter from the main body. Tip separation leads to loss of device function,... read more

FDA/Patient Workshop - Partnering with Patients on CDRH’s Research Agenda for Assistive and/or Neurostimulation Devices, August 1, 2016

The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is announcing an interactive, in-person workshop “Partnering with Patients on CDRH’s Research Agenda for Assistive... read more

Medical Device Interoperability

Medical device interoperability is the ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems. This exchanged information can be used... read more

What's New: Vaccines, Blood & Biologics RSS Feed

November 5, 2013 Approval Letter - Cervarix

October 25, 2013 Approval Letter - Menactra

Vaccines Licensed for Immunization and Distribution in the US with Supporting Documents

This list includes only vaccines for which supporting documents were provided and is arranged alphabetically by the proper name of the product. Information is provided for original product approvals, new... read more

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