By Stewart Eisenhart, Emergo Group Regulators in the US and Brazil have updated their lists of organizations approved to conduct quality system audits under the Medical Device Single Audit Program (MDSAP). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]
Emergo Group
FDA clarifies Early Feasibility Study program for innovative medical devices
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has published new information online explaining how medical device manufacturers may apply and qualify for limited-scope clinical investigations known as Early Feasibility Studies (EFS). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
What FDA medical device user fee reauthorization means for registrants
By Stewart Eisenhart, Emergo Group After two years of negotiations, the US government has enacted the FDA Reauthorization Act of 2017, or FDARA, that enables the agency to continue using medical device, drug and other health product user fees as a key source of funding through 2022. Get the full story here at the Emergo […]
FDA adds UL2900 standard for medical device cybersecurity
By Stewart Eisenhart, Emergo Group US medical device regulators have officially included a new cybersecurity standard from UL to their list of recognized standards for use in premarket reviews. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]
FDA Pre-Certification for Software program key questions and eligibility requirements
By Stewart Eisenhart, Emergo Group Following the rollout of a pre-certification pilot program for digital health technology and software developers, the US Food and Drug Administration has identified and answered several frequently asked questions regarding participation. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
FDA unveils digital health technology changes
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) have published further details on their plans to clarify and improve policies regarding mobile medical applications, wearables and other digital health products. Get the full story here at the Emergo Group’s blog. The […]
Chinese regulators answer two common clinical trial questions
By Stewart Eisenhart, Emergo Group China Food and Drug Administration (CFDA) regulators have addressed frequently asked questions regarding clinical trial requirements for medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com or its […]
India publishes essential principles for medical device and IVD safety and performance
By Stewart Eisenhart, Emergo Group The Central Drugs Standard Control Organization (CDSCO), India’s medical device market regulator, is seeking input from industry on draft essential safety and performance principles included in new regulations launching in 2018. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
Chinese regulators identify first round of medical device clinical trial inspections
By Stewart Eisenhart, Emergo Group Following its recent announcement of a new inspection program for medical device clinical trial sites, the China Food and Drug Administration (CFDA) has identified the first round of sites that will undergo such inspections. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
FDA unveils new policy for accepting medical device consensus standards
By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration have disclosed a new process for evaluating and accepting voluntary consensus standards. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of […]