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 […]
Emergo Group
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 DrugDeliveryBusiness.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 […]
FDA identifies participants for pre-cert digital health tech pilot
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has named all nine participants, including both major technology companies and start-up healthcare software developers, in a new pilot program for digital health product precertification. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
FDA clarifies if microneedling should be classified as a medical device
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have published new guidance clarifying how they determine if microneedling products used for skin treatments qualify as medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only […]
South Korean regulators change new medical device regulations
By Stewart Eisenhart, Emergo Group The South Korean Ministry of Food and Drug Safety (MFDS) have made updates to two significant medical device regulations that came into force earlier in 2017, and published one draft update as well. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Russian regulators changing medical device, IVD regulations
By Stewart Eisenhart, Emergo Group The Russian government has indicated that it may loosen some rules for registration of medical devices and in vitro diagnostic products (IVDs) but also increase regulatory reviews of more substantial registration changes in the coming months. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
FDA plans to launch Premarket Approval pilot program for high-risk medical devices
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans to launch a new pilot program to develop a more efficient premarket approval (PMA) market pathway for some high-risk medical devices. The opinions expressed in this blog post are the author’s only and do not […]
FDA user fees for medical device companies expect 33% rise in 2018
By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fees for medical device registrants will increase across the board for the agency’s next fiscal year starting October 1, 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 not […]