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FDA

Latest Headlines

Latest Headlines

One-hour Ebola test from bioMérieux receives FDA emergency use authorization

The U.S. Food and Drug Administration has given a temporary thumbs up to Ebola test FilmArray BioThreat-E from BioFire Defense, a bioMérieux company. The test offers results in one hour rather than the one to two days required by existing methods.

Attorney: FDA final guidance on product recalls not helpful

FDA's final guidance on medical device recalls and associated reporting requirements omits the most pernicious proposal of the draft guidance, but is of little utility and "will probably soon be forgotten," according to the  FDA Law Blog, written by Hyman, Phelps & McNamara attorneys.   

Medrobotics raises $20M to pursue FDA approval, EU marketing

Medrobotics, a surgical products company focused on medical robotics, raised $20 million in equity financing.

FDA will start the new year with its Office of Quality in place

The Office of Pharmaceutical Quality will finally open Jan. 1, and the FDA's Janet Woodcock will serve as its first acting director.

FDA Commissioner addresses approval times, global competitiveness at AdvaMed

FDA Commissioner Margaret Hamburg devoted a large part of her luncheon remarks at the annual AdvaMed MedTech Conference in Chicago to boosting the American device industry's global competitiveness.

$19M in FDA grants will support rare disease research

The FDA has awarded 15 grants totaling more than $19 million to spur the development of medical devices and drugs to help treat rare diseases.

FDA finalizes cybersecurity guidance in push to secure devices from hackers

The FDA announced that it has finalized its guidance on managing cybersecurity risks as it aims to protect patient privacy and prevent devices from malfunctioning due to computer viruses.

FDA spotlights innovation in 3-D imaging

Breast cancer detection may soon leave 2-D mammography in the dust, embracing instead a more comprehensive diagnostic tool: 3-D technology.

Study: Publicly available information about 510(k) devices' safety and effectiveness lacking

A study published Sept. 29 in The Journal of the American Medical Association concluded that publicly available information to support the safety and effectiveness of implanted, 510(k)-cleared devices is lacking.

Court rules that FDA cannot rescind 510(k)s without notice and comment procedures

The FDA's powers to reclassify devices were restricted by a federal appeals court ruling that said the agency does not have the inherent authority to reclassify devices. Rather, the FDA must follow Congress' procedural requirements when reclassifying devices, including notice and comment procedures.