The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through th

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Neurological Devices Panel of the Medical Devices Advisory Committee. General

The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency.

The Boston Scientific LIVIAN, COGNIS, and CONTAK RENEWAL 3 RF Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are implantable cardioverter defibrillators (ICDs) that also deliver cardiac resynchronization therapy (CRT).

Labeling, Approval Order, and Summary of Safety and Effectiveness for KODAK DirectView CR Mammography System (P080018).

The KODAK DirectView CR Mammography System consists of the KODAK DirectView CR Mammography Cassette with EHR-M Screen designed to fit into the Bucky device of standard mammography x-ray equipment, and the KODAK DirectView CR Mammography Feature Software..

These medical products are contained in sterile pouches that have weak or open seals. These products could become or have been contaminated due to compromise in sterility. This can cause serious adverse health consequences and/or death.

CDRH Learn is our latest innovative educational tool. It consists of a series of training modules describing many aspects of medical device and radiological health regulation, covering both premarket and postmarket issues...

HER2 FISH pharmDx? is a laboratory test that uses DNA probes with fluorescent dyes attached to count how many copies of the HER2 gene, located on chromosome 17, are present in a cancer tissue sample.

Labeling, Approval Order, and Summary of Safety and Effectiveness for HER2 FISH pharmDx? Kit (P040005S005).

HercepTest is a laboratory test that measures how much Her2 protein is being made by the cancer cells. This test has been used in patients with breast cancer and now can be used in patients with spreading (metastatic) stomach (gastric) cancer.

Labeling, Approval Order, and Summary of Safety and Effectiveness for Dako HercepTest (P980018S010).

Labeling, Approval Order, and Summary of Safety and Effectiveness for EC-3 Intraocular Lens (IOL) and EC-3 Precision Aspheric Lens (PAL) IOL (P100016).

The EC-3 Posterior Chamber IOLs (Models EC-3 and EC-3 PAL) are artificial lenses used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. A cataract is a gradual thickening, hardening and clouding of...

This guidance document describes a means by which non-powered suction apparatus devices intended for NPWT may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a...

The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability for...

The purpose of the public workshop is to share FDA's understanding of the risks and benefits of external defibrillators, to clarify FDA's current expectations for how industry should identify, report, and take action on problems observed with these...

This document is intended to assist mammography facilities and their personnel in meeting the requirements of the Mammography Quality Standards Act (MQSA) regulations.

This document is intended to provide guidance to mammography facilities and their personnel. It represents the Food and Drug Administration?s (FDA) current thinking on the final regulations implementing the Mammography Quality Standards Act (MQSA)...

External defibrillators are medical devices that diagnose life-threatening abnormal heart rhythms, or cardiac arrhythmia, and deliver electrical energy to the heart to restore its normal rhythm.

The FDA is holding a public workshop to share FDA?s understanding of the risks and benefits of external defibrillators, to clarify FDA?s current expectations for how industry should identify, report, and take action on problems observed with these devices

The FDA is notifying you of our concerns relating to serious adverse events noted in Medical Device Reports (MDRs) associated with the use of external defibrillators and a large number of recalls of external defibrillators. As a result, FDA may, in the...

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish

These units may fail suddenly causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs. These conditions could result in serious injury or death.

VITEK 2 Gram Negative Susceptibility Cards that contain Piperacillin/Tazobactam are reporting incorrect results for testing the susceptibility of E. coli and K. pneumoniae to this drug.

This guidance document was developed as a special control guidance to support the classification of the non-powered suction apparatus device intended for negative pressure wound therapy (NPWT) into class II (special controls).

This guidance document was developed as a special control to support the classification of the tissue adhesive with adjunct wound closure device intended for the topical approximation of skin into class II (special controls). The device is intended for to

This guidance document describes a means by which tissue adhesives with adjunct wound closure devices intended for the topical approximation of skin may comply with the requirement of special controls for class II devices.

The FDA is classifying the tissue adhesive with adjunct wound closure device intended for topical approximation into class II (special controls).

The FDA is issuing this update to inform you of the findings of its investigation of the manufacturers of CT scanners that were the subject of the earlier communications as well as updated recommendations. In addition, this communication summarizes the...

On September 7, 2006 the U.S. FDA and Health Canada (HC) mailed a letter to U.S. FDA Accredited Persons for Inspection and HC's Third Party Auditing Organizations, called Canadian Medical Devices Conformity Assessment System (CMDCAS)...

The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate.

FDA Patient Safety News is a televised series for health care personnel aimed at hospitals and other medical facilities across the country.

Full-field digital mammographic devices are either integrated systems that include both the x-ray delivery system and integrated (non-removable) detector, or detector-only (removable) systems intended to be used on existing x-ray systems where the...

The Symbiq One and Two-Channel Infusers are infusion pumps intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural...

People screening is the practice of searching people before allowing access to a secure area, for example at airports, court houses, prisons, or museums. People screening electronic products are used to detect concealed weapons, explosives or other...

This device stabilizes and minimizes the motion of selected areas of the beating heart during minimally invasive cardiac procedures while directly visualizing the heart through a small cut in the chest cavity.

Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Draft Guidance, Emergency Use Authorization of Medical Products

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; The Mammography Quality Standards Act Requirements