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In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) expanded the FDA's authorities and strengthened the Agency's ability to safeguard and advance public health. Among other authorities, FDASIA permitted FDA to publish regulations establishing a Unique Device Identification (UDI) system for medical devices.
High signal for paramagnetic substances, such as MRI contrast agents [2] Standard foundation and comparison for other sequences T2 weighted: T2: Measuring spin–spin relaxation by using long TR and TE times Higher signal for more water content [1] Low signal for fat in standard Spine Echo (SE), [1] though not with Fast Spin Echo/Turbo Spin ...
Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.
Medical device maker Medtronic announced in a press release yesterday that it has won FDA regulatory approval for its Advisa DR MRI SureScan pacemaker. The Advisa is Medtronic's second MR ...
* Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products).
For instance, a regulatory agency (such as CE or FDA) may ensure that a product has been validated for general use before approval. An individual laboratory that introduces such an approved medical device may then not need to perform their own validation, but generally still need to perform verification to ensure that the device works correctly ...
Medication that have label indications mean that they were approved by the FDA. This means that they are clinically significant for the indication and manufacturers are allowed to market their drug for the indication. [2] A drug can have more than one FDA labeled indication, which means that it can be used for multiple medical conditions. [5]