By Stewart Eisenhart, Emergo Group New guidance from the US Food and Drug Administration explains how its clinical investigation requirements pertaining to human subject protection policies correspond to US federal policy on human subject protections enforced by the Department of Health and Human Services (HHS). Get the full story here at the Emergo Group’s blog. […]
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KPMG and RAPS finds many medical device companies underprepared for European MDR
By Stewart Eisenhart, Emergo Group A new medical device industry survey shows that many medical device manufacturers still lack long-term plans for compliance to the European Medical Devices Directive (MDR) with a 2020 deadline looming. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
Chinese regulators add more medical devices, IVDs to clinical trial exemption list
By Stewart Eisenhart, Emergo Group China’s National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration, has added more medical device and IVD product types to its list of products exempt from clinical trial requirements in the country. Get the full story here at the Emergo Group’s blog. The opinions expressed […]
Changes to ISO 14155 standard for medical device clinical investigations expected in 2019
By Dietmar Falke Aleksandra Klimaszewski and Stewart Eisenhart, Emergo Group Revisions to the ISO 14155 standard covering pre- and post-market clinical investigations for medical devices are set to take effect in 2019. Manufacturers and clinical trial sponsors should consider ramifications of the updated standard for risk management and related issues if they have not already […]
FDA announces key guidance publication plans for 2019
By Stewart Eisenhart, Emergo Group Updated cybersecurity requirements for medical device premarket submissions, Abbreviated and Special 510(k) program refinements, and medical software policy changes stemming from the 21st Century Cures Act rank highly among topics for a new list of guidance documents the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) […]
FDA launches pilot to expand special 510(k) market pathway
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration has initiated a new pilot program for expanded eligibility in the agency’s Special 510(k) pathway, potentially easing market compliance requirements for more manufacturers whose devices have undergone modifications. Get the full story here at the Emergo Group’s blog. The opinions […]
What “no-deal” Brexit means for medical devices
By Ronald Boumans, Emergo Group The UK will leave the European Union on March 29, 2019 – Brexit day. On that day the EU will lose an important Member State, and the UK will no longer have direct access to the 27 remaining Member States. Therefore both the EU and the UK want to work […]
India regulators update medical device and IVD oversight programs
By Stewart Eisenhart, Emergo Group Indian regulators have recently announced several updates regarding their medical device and IVD oversight programs. 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.
U.S. regulators to overhaul third-party 510(k) review program
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has set a goal of obviating the need to re-review 85% or more of 510(k) applications that have undergone third-party review by the agency’s 2021 fiscal year. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Brazil ANVISA develops new regulations for custom-made medical devices
By Stewart Eisenhart, Emergo Group ANVISA, Brazil’s medical device market regulator, has issued a public consultation to establish new requirements pertaining to custom-made devices. 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 […]