By: Vanessa Burrows Since the discovery of X-rays in the late 19th century, the technology has enhanced health care in a variety of ways. Like many cutting-edge scientific developments, however, it also has inspired uses of uncertain therapeutic value. That was the case with the shoe-fitting fluoroscope, the subject of the latest episode of FDA’s […]
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FDA and NIH launch new clinical trial protocol writing tool
By Stewart Eisenhart, Emergo Group US regulators at the Food and Drug Administration and the National Institutes of Health (NIH) have published a new writing tool for use in applying for regulatory approval to conduct clinical trials for medical devices and pharmaceuticals. Get the full story here at the Emergo Group’s blog. The opinions expressed […]
FDA proposes Conformity Assessment pilot
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have begun seeking stakeholder feedback for a proposed system to better evaluate registrants’ compliance with 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 […]
Dr. Gottlieb’s first remarks to FDA staff
Remarks by Scott Gottlieb, M.D. FDA All Hands Meeting May 15, 2017 Silver Spring, MD It’s an honor to be here today and to be taking on this responsibility with all of you. You realize how special our mission of consumer protection and public health promotion is when you explain what we do to the children […]
China regulators formalize procedures for medical device expert panel meetings
By Stewart Eisenhart, Emergo Group Regulators at the China Food and Drug Administration (CFDA) have published formal procedures for expert panel meetings held to discuss medical device registration issues, clarifying the process for Chinese market applicants. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
Eurasian governments progress on unified device regulatory system
By Stewart Eisenhart, Emergo Group Regulators in five Eurasian countries report progress in efforts to establish a harmonized medical device market that would incorporate Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan. 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 […]
European medical device and IVD regulations officially published
By Stewart Eisenhart, Emergo Group The European Commission has officially published the Medical Device Regulations (MDR) 2017/745 and In Vitro Diagnostic Regulations (IVDR) 2017/746 on May 5, 2017 in the Official Journal of the European Union (OJEU). The MDR will replace the Active Implantable Medical Devices Directive (90/385/EEC — AIMD) and the Medical Devices Directive […]
Common audit problems: Publishing audit reports
By Stewart Eisenhart, Emergo Group In the final installment of Emergo’s blog series on medical device quality management system audit problems, we examine the audit report publication process and related challenges. 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 […]
China FDA clarifies device recall requirements
By Stewart Eisenhart, Emergo Group Chinese medical device market regulators have made reporting forms necessary for recall management available online. 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 employees.
FDA and NIH release final template for clinical trial protocols
By: Peter Marks, M.D., Ph.D. A little more than a year ago, FDA and NIH announced the availability of a draft template for investigators to use when organizing clinical trial protocols, which are essentially roadmaps for conducting a clinical trial. Today, we are excited to announce that the NIH-FDA Joint Leadership Council has issued a final […]
