Nemaura Medical (NSDQ:NMRD) this week said it submitted a De Novo medical device applications to the FDA for its SugarBEAT non-invasive glucose monitor. The Loughborough, England-based company recently successfully completed clinical studies and two summative human factors usability studies needed to support De Novo submission. “We are pleased to have submitted our De Novo 510(k) application […]
European Commission publishes guidance on responsible person requirements under MDR, IVDR
By Stewart Eisenhart, Emergo Group European regulators have published new guidance documents addressing persons responsible for managing compliance with the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). 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 […]
China NMPA releases new eRPS medical device registration system details
By Stewart Eisenhart, Emergo Group Emergo by UL has learned additional details regarding the China National Medical Product Administration’s (NMPA) new electronic medical device registration management (eRPS) system. 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 […]
FDA issues final rule for appealing medical device regulatory decisions
By Stewart Eisenhart, Emergo Group A final rule recently issued by the US Food and Drug Administration explains procedures and timeframe requirements whereby regulatory decisions by the agency’s Center for Devices and Radiological Health (CDRH) may be appealed. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Australia regulators publish guidance on recognized QMS standards
By Kate Jablonski, Emergo Group The Australia Therapeutic Goods Administration (TGA) published guidance on its recent update to Medical Device Standards Order (MDSO), Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019, on June 19. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
Kurve, Suerat partnered in nasal-delivery migraine treatment deal
Kurve Technology last week announced a new development and collaboration agreement with Seurat Therapeutics for migraine prevention in adults. Mill Creek, Wash.-based Kurve Technology develops and markets intranasal drug delivery devices that transport liquid compounds from the nose to the brain to treat Alzheimer’s PTSD, multiple sclerosis and more. “Both Seurat and Kurve are proud […]
South Korean regulators establish new regulations for IVD devices
By Stewart Eisenhart, Emergo Group The South Korean Ministry for Food and Drug Safety (MFDS) has established new regulations for registration of IVD products in order to improve oversight of these devices’ safety and quality, according to the agency. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
Ocular Therapeutix launches Dextenza eye insert
Ocular Therapeutix (NSDQ:OCUL) yesterday announced the commercial launch of its Dextenza ophthalmic insert in the U.S. Dextenza is an ocular insert that is designed to release 0.4 mg of dexamethasone to relieve pain after ophthalmic surgery. It can deliver drugs for up to 30 days after treatment in a physician’s office. The Bedford, Mass.-based company won […]
South Korea trade group, Emergo partnered for medical device RA/QA support
By Stewart Eisenhart, Emergo Group The Korea Medical Devices Industrial Cooperative Association (KMDICA), a South Korean medical device industry association, has partnered with global regulatory consulting firm Emergo by UL to provide European market compliance support to the group’s more than 500 member companies. Get the full story here at the Emergo Group’s blog. The […]
FDA ends medical device Alternative Support Program
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s medical device oversight division has ended reporting exemptions for some manufacturers and made more report data publicly available in an effort to boost transparency and better monitor product safety. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]