By Stewart Eisenhart, Emergo Group The Australian Therapeutic Goods Administration (TGA) plans to roll out “simplified and improved arrangements” for managing complaints regarding medical device and drug advertising. 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 […]
Emergo Group
Medical device R&D investments expected to rise through 2018
By Stewart Eisenhart, Emergo Group An Emergo survey of medical device companies finds that a higher percentage of smaller firms plan to increase their research and design spending over the next year than mid- and large-sized firms. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
Chinese regulators starting medical device clinical trial inspection program
By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) plans to begin conducting on-site inspections of clinical trials for medical devices in an effort to improve clinical data used in premarket review decisions. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
FDA recognizes UL 2900 cybersecurity standards
By Stewart Eisenhart, Emergo Group A set of standards published by UL to address medical device cybersecurity issues will soon be adopted by the US Food and Drug Administration to help manufacturers support security assurance claims. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
Brazil adds Irish Standards Authority to accredited list of MDSAP auditors
By Stewart Eisenhart, Emergo Group Brazilian medical device regulators have recognized the National Standards Authority of Ireland (NSAI) as accredited 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 […]
India CDSCO draft clarifies medical device, IVD registrations
By Stewart Eisenhart, Emergo Group Indian medical device market regulators have published a new draft list of medical devices that clarifies how they’ll be classified under the new Medical Device Rules 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 […]
New Canadian medical device incident reporting rules proposals
By Stewart Eisenhart, Emergo Group Canadian healthcare market regulator Health Canada is developing new requirements for certain hospitals to report serious medical device incidents and adverse drug reactions to better protect public health. 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 user fee reauthorization advances without $1B fee increase
By Stewart Eisenhart, Emergo Group The US Senate’s version of a bill reauthorizing Food and Drug Administration user fees over the next several years diverges markedly from President Trump’s budget proposal to increase user fees by $1 billion in 2018 alone. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
FDA guidance explains electronic records for medical device clinical trials
By Stewart Eisenhart, Emergo Group US Food and Drug Administration medical device regulators have published new draft guidance recommending proper use of electronic records and signatures in clinical investigations. 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 commissioner proposes new program for digital health product regulations
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration plans to roll out a new program for mobile medical apps and related digital health products in order to clarify the agency’s regulatory scope regarding these technologies. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]