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CDRH has reviewed 69 percent of PMA products approved before 2010 — exceeding its 2014 target — as it works to implement a goal of speeding new technologies to patients without compromising safety. Read More
Devicemakers are doing a better job meeting FDA standards for 510(k) submissions, CDRH Director Jeffrey Shuren told an industry group Thursday. Read More
The House Energy and Commerce Committee’s proposed legislation sets in motion an expedited pathway to speed access to breakthrough medical technologies. Read More
The China Food and Drug Administration has issued 90 industry standards – 14 mandatory and 76 recommended – covering implants for surgery, medical electrical equipment, in vitro diagnostic reagents and dentistry. Read More
Ongoing Federal Trade Commission demands for more scientific information to back marketing claims may affect some devicemakers, experts said Tuesday at the Food & Drug Law institute in Washington, D.C. Read More
Effective July 1, devicemakers seeking to register products in Taiwan will need to have their quality system documents approved before submitting an application. Read More