By Stewart Eisenhart, Emergo Group The South African government has formed a new agency to oversee new medical device and pharmaceutical regulatory systems being developed in the country. 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 […]
blog
Statement from FDA Commissioner on opioid drugs with abuse-deterrent properties
Last month, I asked my colleagues at the FDA to identify what additional and more forceful steps the FDA can take, on top of the vigorous work the agency is already doing, to address the crisis of opioid addiction. Everyone at the FDA is committed to focusing on all aspects of the epidemic. The new […]
FDA changes medical device clinical trial IRB requirements
By Stewart Eisenhart, Emergo Group Medical device companies conducting certain types of clinical trials may now rely on central rather than local Institutional Review Boards (IRB) for reviews required by the US Food and Drug Administration. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
FDA extends UDI deadline for Class I devices
By Stewart Eisenhart, Emergo Group US Food and Drug Administration medical device regulators have extended Unique Device Identification (UDI) labeling and related compliance deadlines for lower-risk devices to late 2022 in order to fully standardize and optimize UDI data already collected on high-risk devices. Get the full story here at the Emergo Group’s blog. The […]
Australian regulators seek faster market access for device approvals overseas
By Stewart Eisenhart, Emergo Group Australia’s Therapeutic Goods Administration (TGA) has proposed allowing commercialization of medical devices that have already obtained approval from regulators in other markets without undergoing full premarket review. 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 […]
Trump budget proposes $1B FDA user fee increase
By Stewart Eisenhart, Emergo Group The Trump Administration’s proposed 2018 federal budget would boost Food and Drug Administration user fees from medical device and drug registrants by more than $1 billion, in contrast to ongoing Congressional user fee negotiations that do not include such steep increases. Get the full story here at the Emergo Group’s […]
European MDR, IVDR officially entered into force
By Stewart Eisenhart, Emergo Group The May 26, 2017 date for official entry into force of new European medical device and IVD regulations has been reached, paving the way for full implementation of these regulations in 2020 and 2022. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
FDA cybersecurity workshop offers long-term solutions for medical device sector
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s latest workshop on medical device cybersecurity issues, held May 18 and 19, 2017, firmly established myriad challenges in mitigating this risk, and that no easy or quick fixes are yet available to help manufacturers and other stakeholders address these challenges. Get the full story […]
FDA Commissioner asks staff for ‘more forceful steps’ to stem the opioid crisis
By: Scott Gottlieb, M.D. As Commissioner, my highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction. I believe the Food and Drug Administration continues to have an important role to play in addressing this crisis, particularly when it comes to reducing the number of new cases […]
FDA launches medical device cybersecurity workshop
By Stewart Eisenhart, Emergo Group Effectiveness of ongoing efforts to address medical device cybersecurity risks will depend on whether stakeholders can properly balance security, safety and usability issues as well as understand end-user environments, according to speakers at a new US Food and Drug Administration workshop. Get the full story here at the Emergo Group’s […]