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  2. FDA Center for Devices and Radiological Health - Wikipedia

    en.wikipedia.org/wiki/FDA_Center_for_Devices_and...

    Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]

  3. Perflubron - Wikipedia

    en.wikipedia.org/wiki/Perflubron

    Perflubron (INN/USAN, or perfluorooctyl bromide; brand name Imagent) is a contrast medium for magnetic resonance imaging, computer tomography and sonography. [1] It was approved for this use in the United States by the Food and Drug Administration in 1993. [2]

  4. Imaging biomarker - Wikipedia

    en.wikipedia.org/wiki/Imaging_biomarker

    The FDA Modernization Act of 1997 was instituted to improve the regulatory process for medical products. Section 112 of the Act gives explicit authority to give expedited approval for drugs that treat serious conditions as long as it has shown to have an effect on a surrogate end-point that reasonably indicates a clinical benefit.

  5. Medtronic Wins FDA Approval for MRI-Accessible Pacemaker - AOL

    www.aol.com/news/2013-02-14-medtronic-wins-fda...

    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 ...

  6. Safety of magnetic resonance imaging - Wikipedia

    en.wikipedia.org/wiki/Safety_of_magnetic...

    All patients are reviewed for contraindications prior to MRI scanning. Medical devices and implants are categorized as MR Safe, MR Conditional or MR Unsafe: [6] MR-Safe – The device or implant is completely non-magnetic, non-electrically conductive, and non-RF reactive, eliminating all of the primary potential threats during an MRI procedure.

  7. Unique Device Identification - Wikipedia

    en.wikipedia.org/wiki/Unique_Device_Identification

    In a medical sense, "device" refers to any product that is not pharmaceutical in nature, and while the FDA have been given approval to exempt some devices, Jay Crowely (who was responsible for implementing the UDI requirements in the Act), has expressed an intent to apply the UDI to "everything until somebody gives us good reason not to ...

  8. Food and Drug Administration - Wikipedia

    en.wikipedia.org/wiki/Food_and_Drug_Administration

    The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...

  9. AOL Mail

    mail.aol.com

    Get AOL Mail for FREE! Manage your email like never before with travel, photo & document views. Personalize your inbox with themes & tabs. You've Got Mail!

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