By Stewart Eisenhart, Emergo Group The South Korean Ministry of Food and Drug Safety (MFDS) have made updates to two significant medical device regulations that came into force earlier in 2017, and published one draft update as well. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
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Russian regulators changing medical device, IVD regulations
By Stewart Eisenhart, Emergo Group The Russian government has indicated that it may loosen some rules for registration of medical devices and in vitro diagnostic products (IVDs) but also increase regulatory reviews of more substantial registration changes in the coming months. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
FDA plans to launch Premarket Approval pilot program for high-risk medical devices
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans to launch a new pilot program to develop a more efficient premarket approval (PMA) market pathway for some high-risk medical devices. The opinions expressed in this blog post are the author’s only and do not […]
FDA user fees for medical device companies expect 33% rise in 2018
By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fees for medical device registrants will increase across the board for the agency’s next fiscal year starting October 1, 2017. 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 […]
FDA, Brazil ANVISA update MDSAP medical device QMS audit organizations lists
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 […]
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 […]
FDARA: Making a difference for industry and patients
By: Peter Marks, M.D., Ph.D., Jeffrey Shuren, M.D., J.D., and Janet Woodcock, M.D. For decades, user fees paid by the medical products industry have provided critical resources needed to conduct product reviews in a timely fashion and to help ensure the safety and effectiveness of medical products that American patients depend upon. Since passage of […]
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 […]
