The Food and Drug Administration has released a draft guidance to provide recommendations that seek to help companies address cyber risks in medical devices prior to the submission of premarket applications for
MoreThe Food and Drug Administration and Department of Homeland Security have partnered to resolve cybersecurity issues in medical systems to maintain patient safety.
MoreScott Gottlieb, commissioner of the Food and Drug Administration, has introduced information technology initiatives under the agency’s data science incubator program during the Health Datapalooza conference in Washington, D.C., MedCityNews reported Thursday. Gottlieb highlighted
MoreThe Food and Drug Administration has announced a new project that aims to leverage the cybersecurity of medical technologies, FedScoop reported Friday. The Medical Device Safety Action Plan will rely on the FDAâs previous
MoreThe Food and Drug Administration and the Defense Department have kicked off a joint program to speed up the development and availability of emergency medical products for the U.S. military. FDA said Tuesday
MoreThe Food and Drug Administration has approved a hemorrhagic shock detection device that U.S. Army researchers developed alongside scientists and engineers from the University of Colorado and Flashback Technologies. The Army Institute of Surgical Research
MoreThe Food and Drug Administration has issued a final set of guidelines meant to help manufacturers secure medical devices from postmarket cyber vulnerabilities. Suzanne Schwartz, associate director for science and strategic partnerships at the
MoreThe Government Accountability Office has recommended the Food and Drug Administration fully implement an agency-wide information security program and take 166 specific actions to address gaps in information security controls. GAO said in
MoreThe Food and Drug Administration has released two draft guidance documents that seek to provide a streamlined oversight process for genomic tests as part of the Precision Medicine Initiative established by the Obama Administration. FDA proposed
MoreRep. Jim Langevin (D-R.I.) has voiced support for the Food and Drug Administration‘s draft guidance for manufacturers to protect medical technology products against cybersecurity threats. Langevin, co-chair of the Congressional Cybersecurity Caucus, said Thursday he believes the guidance FDA issued
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