In the absence of either an FY 2014 appropriation or a Continuing Resolution for FDA, beginning on October 1 and continuing until the date of enactment of an FY 2014 appropriation or Continuing Resolution (“lapse period”), agency operations will be limited to the following:
The US Food and Drug Administration (FDA) is giving the medical device industry a glimpse into the guidance documents it plans to release in the current fiscal year, including several of key interest to both the traditional device industry and emerging tech sectors.
As a professional network for physicians, Doximity continues to assist doctors in a variety of ways, including saving time in emergency situations with patients. The secure platform launched about two and half years ago, and although Doximity is based in the San Francisco Bay area, it is available nationwide with more than 220,000 physicians across the country using the service. In medical emergencies, primary care physicians can fax medical records that attending doctors can retrieve in minutes on their iPads. Doximity executives say that this process has saved lives.
Medtronic Inc. said Friday that it has won U.S. government approval for what it said is the first artificial pancreas system that automatically stops insulin treatment for diabetics when the patient has had enough.
From advanced medical products to polymers to PLCs, recent reports point to continued growth in China.
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has released an extensive new final guidance document on the design of pivotal clinical investigations meant to support the approval of medical devices.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Minimizing Risk for Children’s Toy Laser Products. ” This draft guidance is to inform manufacturers of laser products, FDA headquarters and field personnel, and the public of the Center for Devices and Radiological Health’s (CDRH) proposed approach on the safety of toy laser products. This draft guidance is not final nor is it in effect at this time.
Medical device manufacturers filing Investigational Device Exemption (IDE) submissions for clinical investigation approval will soon find a more efficient and updated application process, according to the US Food and Drug Administration.