SteadyMed Therapeutics (NSDQ:STDY) said last week that it inked an exclusive deal with Cardiome for commercialization of its Treyvant product in regions outside the U.S., hinging on its regulatory approval in those regions. Cardiome will have exclusive rights to the territories of the European Union, Canada and the Middle East, SteadyMed said. SteadyMed is a developer […]
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US FDA finalizes 510(k) exemptions for some Class I and II medical devices
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has finalized plans to exempt some “well understood” Class I and II medical devices from 510(k) premarket notification requirements, according to new guidance from the agency.
US FDA addresses UDI direct marking for reprocessed devices
By Stewart Eisenhart, Emergo Group New draft guidance from the US Food and Drug Administration seeks comment on how to effectively apply requirements that Unique Device Identification data be applied directly to medical devices intended for reprocessing and reuse. The agency’s guidance points out that its UDI rule, 21 CFR 801.25, explicitly requires directing UDI marking on […]
Hong Kong regulators issue list of recognized standards for medical devices
By Stewart Eisenhart, Emergo Group Regulators in Hong Kong have published a new list of recognized standards applicable to medical devices as the region moves toward more formal oversight of its device market.
Emergo Podcast: ANVISA medical device approval in Brazil
By Stewart Eisenhart, Emergo Group Brazil’s medical device market offers significant growth potential for foreign manufacturers, but the country’s device approval process is challenging. In this podcast, Emergo Vice President of Business Development Ann Marie Boullie provides an overview of Brazil’s regulatory requirements for medical device registration, including:
New US FDA guidance: Six benefit-risk factors to include in medical device IDE applications
By Stewart Eisenhart, Emergo Group In an effort to boost predictability and transparency of its Investigational Device Exemption (IDE) review process, the US Food and Drug Administration has published new guidance explaining key issues the agency uses to assess benefits and risks of IDE submissions for clinical investigations of Class III and some Class II […]
New medical device barcodes required by Saudi regulators
By Stewart Eisenhart, Emergo Group New rules issued by medical device market regulators in the Kingdom of Saudi Arabia require new barcodes for some types of devices registered for sale in the KSA.
Zimmer recalls some M/L Taper hip prostheses
Zimmer (NYSE:ZMH) is recalling some of its M/L Taper hip prosthesis with femoral stems and necks due to an issue concerning manufacturing residue on the devices, according to the FDA. The FDA labeled it a Class I recall, the most serious type of recall issued by the federal watchdog, indicating that “there is a reasonable probability that […]
Emergo Podcast: Medical Device Licensing and Approval in Canada
By Stewart Eisenhart, Emergo Group Medical device manufacturers thinking about market authorization pathways in Canada can learn more about the process via this Emergo podcast. Emergo Managing Director for Canada Daryl Wisdahl explains key issues related to Canadian regulatory requirements for medical devices, including:
ANVISA extends deadline for technical requirement responses in Brazil
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has officially extended deadlines for market applicants to respond to technical inquiries regarding their registration submissions.
CMS issues National Coverage Decision for pacemakers dangerous to patients
By Westby G. Fisher, MD, FACC Who needs the Independent Payment Advisory Board to limit indicated care for patients when you have the Center for Medicare and Medicaid Services (CMS)? Today I learned that CMS has issued a National Coverage Decision (NCD) for pacemakers effective 6 July 2015 that would restrict pacemaker implants to patients with […]