By Stewart Eisenhart, Emergo Group Brazilian medical device regulator ANVISA has adjusted its electronic submission policy for marketing authorization applications, now accepting both electronic and paper formats of documents. 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 […]
Emergo Group
Peruvian regulators push for faster medical device approval timeframes
By Stewart Eisenhart, Emergo Group The Peruvian government has rolled out a raft of updates to the country’s medical device regulatory system, including an initiative to reduce approval timeframes for all device classes. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
FDA expands 510(k) validation data requirements for reusable devices
By Stewart Eisenhart, Emergo Group Medical device market regulators at the Food and Drug Administration have issued a new list of reusable medical devices for which validated Instructions for Use as well as validation data for cleaning and sterilization will be required for 510(k) submissions. Get the full story here at the Emergo Group’s blog. […]
South African government forms medical device and drug market regulatory body
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 […]
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 […]