The manufacturing, repackaging, re-labeling and importation of medical devices is regulated by the Center for Devices and Radiological Health (CDRH), a department of the Federal Food and Drug Administration (FDA). All medical devices sold in the United States are classified according to the level of precision required to operate the device safely and effectively. Reports on devices which have malfunctioned or caused death or serious injury are collected by the CDRH and stored in the Medical Device Reporting (MDR) database and the Manufacturer and User Facility Device Experience (MAUDE) database.
Medical Devices and Products Recalls
At least weekly the Food and Drug Administration (FDA) issues health warnings and recall notices to the public. A recall is a method of removing or correcting medical products that are in violation of laws administered by the FDA. Recall is a generally voluntary action that takes place because medical device manufacturers and distributors carry out their responsibility to protect the public health and well being from products that present a risk of injury or gross deception or are otherwise defective.
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Medical Devices -- An Overview
The Federal Food and Drug Administration (FDA)`s Center for Devices and Radiological Health (CDRH) is responsible for regulating companies/firms who manufacture, repackage, re-label, and/or import medical devices that are sold in the U.S. In addition, the CDRH regulates radiation emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, etc. The CDRH maintains information collected from device experience reports on medical devices which may have malfunctioned or caused a death or serious injury.
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Medical Devices Jury Verdicts
______ $1.5 million against Greater Southeast only. Defense verdict for Defendant Jamshidi. - Medical Malpractice Medical Malpractice - Comatose Patient - Physical Therapy - Hospital Negligence
______ $297,000 plus interest against defendant corporation and defense verdict as to Defendants Fadem. - Contract Contract - Corporate Merger - Finder's Fee
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Medical Devices News Articles
Medical Device Documentation Engineer
Elana Receives FDA Approval For Lifesaving Bypass Device
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Medical Devices Newsfeeds
AMD Embedded G-Series Platform Gets Real-Time Operating System Support from Express Logic
Vishay Intertechnology Corporate Video Now Available in Japanese, Chinese, and Korean Translations on Website
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Medical Devices Useful Web Sites
Anapol Schwartz, Medical Device Attorneys
Cohen Placitella and Roth, Medical Devices Attorneys
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Medical Devices Wikipedia
Medical device
Medical equipment
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