Malaysian regulators extend moratorium to summer 2018 for qualifying medical device registrants

Stewart Eisenhart, Emergo Group The Medical Device Authority (MDA), Malaysia’s medical device regulator, will extend a moratorium for companies that have registered for market access but not yet received approval so that they may continue selling in the country as their premarket reviews proceed. Get the full story here at the Emergo Group’s blog. The

Medical Device Excise Tax set to return early this year

By Stewart Eisenhart, Emergo Group Despite multi-year efforts to fully repeal the Medical Device Excise Tax (MDET) on device sales in the US, the tax appears set to come back into force in early 2018. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s

FDA refines least burdensome guidance for medical device oversight

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 MedicalDesignandOutsourcing.com

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

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. 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

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

FDA issues final guidance on medical device changes that need new 510(k) submissions

By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have published final guidance explaining when changes to registered devices warrant filing new 510(k) premarket notifications to the agency. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only

Europe’s new plan to address orphaned medical device manufacturers

By Annette van Raamsdonk, Emergo Group European Member States are implementing a procedure for manufacturers that no longer have a Notified Body (NB) due to scope reduction or de-notification. 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 launches new market pathway for breakthrough medical devices

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration plans to establish a new market authorization pathway for innovative and breakthrough medical devices that would replace current priority review programs including the Expedited Access Pathway (EAP) and the Priority Review Program. Get the full story here at the Emergo Group’s blog. The opinions

Australian TGA updates medical device recall process in early 2018

By Stewart Eisenhart, Emergo Group Australian medical device regulators will implement changes to their recall requirements for medical devices and other healthcare products in January 2018. 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 MedicalDesignandOutsourcing.com

FDA updates premarket review appeals and deficiency letters guidances

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has updated guidance documents covering appeals processes and procedures for medical device premarket review decisions, as well as for developing requests for additional information for FDA registrants whose applications are deemed deficient. Get the full story here