The European Parliament has voted in favor of implementing stricter requirements for Notified Bodies, but not for recommended medical device registration reforms that would create an approval process similar to Premarket Approval in the US.
The Advanced Medical Technology Association (AdvaMed), an association of international medical device manufacturers, has urged the Parliamentary Standing Committee on Health and Family Welfare to consider its recommendations for the Drugs & Cosmetic (Amendment) Bill 2013 (known as the medical devices bill) so that the benefits of the bill can result in faster and safer solutions for Indian patients and more investments for the country.
Just days after President Barack Obama signed the Drug Quality and Security Act (DQSA) into law, the US Food and Drug Administration (FDA) has released three draft guidance documents intended to interpret its provisions and provide definitional clarity for compounding pharmacies.
The China Food and Drug Administration has published a list of roughly 130 Class II devices that are exempt from submitting clinical trial data.
A new AdvaMed report reveals that variations in medical device prices are not the reason for wide differences in overall hospital bills.
The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use.
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.