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’s role in medical device cybersecurity

Dr. Suzanne Schwartz, FDA Virtually every aspect of our lives – including our health – has gone digital. Medical devices from insulin pumps to implantable cardiac pacemakers are becoming more interconnected and, like computers and the networks they operate in can be vulnerable to security breaches. A computer virus or hack resulting in the loss of

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

The Mammography Quality Standards Act: A 25-year public health success story

By: Dr. Helen Barr Mammography has been widely used as a screening tool to detect early-stage breast cancer since the mid-1960s. As the use of the technology expanded it became clear that there were wide variations in the quality of the mammograms and the dose being delivered to patients. Following a series of hearings, Congress stepped

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

Expanded Access: FDA describes efforts to ease application process

By: Scott Gottlieb, M.D. FDA has a long history of supporting patient access to investigational new treatments. This includes working with drug and device companies through the clinical trial process that may lead to FDA approval of the treatment. We also offer expanded access programs that provide investigational drugs and devices to patients with serious

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

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

Saudi regulators reportedly exempt some Class I medical devices from registration

By Stewart Eisenhart, Emergo Group Regulators at the Saudi Food and Drug Authority (SFDA) may soon exempt some Class I medical devices from registration requirements according to Emergo sources in Riyadh. 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

Industry trade groups want full MDR, IVDR implementation in U.K. post-Brexit

By Stewart Eisenhart, Emergo Group Medical device and IVD trade groups in Europe and the UK have appealed to maintain a uniform system for CE Marking and regulatory oversight as negotiators work out British withdrawal from the European Union under Brexit. Get the full story here at the Emergo Group’s blog. The opinions expressed in

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