The US Department of Health and Human Services Department (DHHS) proposed a new rule with respect to Clinical Trial Registration and Results Submission. This proposed rule Continue reading
As part of Health Canada’s “ongoing efficiency measures and efforts to reduce regulatory burden on industry and transition to an electronic environment, … [Health Canada announced Continue reading
The US FDA has released a final guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Devices to strengthen the safety of medical devices.
Although medical devices have the ability to improve patient care and create efficiencies in the healthcare system as they become more interconnected and interoperable, risks for Continue reading
On April 23, 2014 the FDA released for comment purposes only, the Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions – Draft Guidance for Industry. Comments should be received by the FDA within 90 days of publication in the Federal Register.
The Expedited Access for Premarket Approval (EAP) is a new “voluntary program for Continue reading
With the potential impact of biofilms – colonies of microbes which physically adhere to materials, such as a medical device – on the safety of medical devices, US regulators are poised to Continue reading
The US FDA recently released a new draft guidance which provides recommendations to sponsors of medical device applications on how they should Continue reading
On December 13, 2013 the FDA announced improvements to public databases with the intent to increase access to safety information on marketed medical devices. One of the key improvements made was Continue reading
September 24, 2013. The US Food and Drug Administration (FDA) issued a draft guidance that proposed requiring medical device manufacturers to include unique identifying numbers on their products. This guidance comes as part of the agency’s efforts to Continue reading
On October 22, 2013 new legislation was introduced that would prevent the US Food and Drug Administration (FDA) from regulating mobile medical apps that do not meet a newly defined regulatory definition of Continue reading
On September 25, 2013, the FDA released its final guidance for industry on the use of mobile medical apps. Mobile apps have the potential to transform the healthcare industry by allowing doctors to Continue reading