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Added two types of annual fees: establishment registration fee and product fee 2012: MDUFA III: Safety and Innovation Act of 2012: Expanded the definition of establishments subject to a registration fee, thus increasing the applicable device establishments paying the fee. 2017: MDUFA IV: FDA Reauthorization Act of 2017
It is possible to convert air crew licences issued by other ICAO member states ("third countries") to an EASA licence. The applicant must have a valid third country licence and valid medical certificate. They must also hold a valid EASA medical certificate. They must pass all fourteen EASA theoretical exams.
The EU acted to adopt UDI and on April 5, 2017, under the Medical Devices Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR), but adoption has been postponed to 2021; see Medical Device Regulation. The timelines for UDI marking of medical devices, direct marking of medical devices, and marking of IVD allow for a staggered introduction. [8]
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
Medical device cannot be classified as a class II device because insufficient information exists for the establishment of a performance standard to provide reasonable assurance of its safety and effectiveness of the device. Medical device is to be for use in supporting or sustaining human life, of substantial importance in preventing impairment ...
EASA: NPRM notice of proposed rulemaking FAA: NRR noise reduction rating hearing protector attenuation: NRTC nonroutine task card NVD Night-vision device: Or: Night-vision goggles (NVG) NTSB National Transportation Safety Board: U.S. governmental agency NTZ no-transgression zone: Parallel runways operation
Data on economic operators, devices registration and certificates are available to the public. The database will allow to link manufacturer's certification and Single Registration Number (SRN) as well as the Basic UDI. The so-called "Summary of Safety and Clinical Performance" (SSCP), required for some high-risk medical devices, will also be ...
In 2012 it represented 38% of the global market and more than 6500 medical device companies exist nationwide. These companies are primarily small-scale operations with fewer than 50 employees. The most medical device companies are in the states of California, Florida, New York, Pennsylvania, Michigan, Massachusetts, Illinois, Minnesota, and ...