By Stewart Eisenhart, Emergo Group Medical device regulators at the Food and Drug Administration have updated guidance clarifying what Least Burdensome Provisions mean for US market registrants. 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 […]
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Upcoming changes to FDA electronic medical device reporting in 2018
Registrar Corp. Medical device manufacturers and importers are required to report “adverse events” to FDA when their device has caused or contributed to death or serious injury. An adverse event is when a device has a malfunction that could cause death or serious injury. Importers report this information to the manufacturer. The FDA has announced […]
European Union IoT cybersecurity recommendations for medical devices
By Stewart Eisenhart, Emergo Group A new set of critical infrastructure security recommendations from European regulators targets the Internet of Things (IoT), with significant implications for medical device manufacturers and health technology developers’ cybersecurity risk mitigation efforts ahead of a major data protection compliance deadline in 2018. Get the full story here at the Emergo […]
Effective design considerations for medical device warning labels
By Michael Wiklund, Emergo Group Some people believe that warnings are useless; printed on medical devices only to offer legal protection. Indeed, manufacturers can and have been held liable for the “failure to warn,” and adding warnings neutralizes this claim. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]
New FDA guidance for dual submission 510(k) and CLIA waiver application for IVD companies
By Stewart Eisenhart, Emergo Group New guidance from the US Food and Drug Administration explains requirements for in vitro diagnostic manufacturers to register for premarket notification using the agency’s Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]
FDA publishes final guidance for UDI direct marking requirements
David Lennarz, Registrar Corp. The U.S. Food and Drug Administration (FDA) requires devices intended to be reprocessed or devices intended to be used more than once by multiple patients to physically bear a permanent unique device identifier (UDI) marking that lasts the duration of the devices’ expected lifetime. This is known as UDI direct marking. […]
New harmonized standards for medical devices, IVD in Europe
By Stewart Eisenhart, Emergo Group The European Commission has issued updated lists of harmonized standards for medical devices and in-vitro diagnostic (IVD) products in the Official Journal of the European Union (OJEU). 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 […]
The FAQs on encryption, FIPS 140 and medical devices
By Stewart Eisenhart, Emergo Group As cybersecurity vulnerabilities become a more urgent concern for the medical device industry, encryption requirements are emerging as a key tool to address medical device cybersecurity concerns. In the US, compliance with the FIPS 140-2 standard can help manufacturers of network-connected devices and software demonstrate encryption capabilities able to protect […]
Brazilian regulators propose easier market pathway for low-risk medical devices and IVDs
By Stewart Eisenhart, Emergo Group Medical device and IVD regulators in Brazil plan to loosen market access for low-risk devices and IVDs by introducing a notification-only registration system for these products. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com or its employees.
Pros and cons of MDNR and MDMA medical device registration in Saudi Arabia
By Stewart Eisenhart, Emergo Group Now that Saudi Arabian medical device regulators have exempted some low-risk products from full registration requirements, qualifying manufacturers should consider whether standard or fast-track access to the Saudi market best suits their business needs. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]