Medical Devices
from Pro Pharma Talks Hosted by Pro Pharma
Medical Devices - BP meters, blood glucose monitors - The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are: - Establishment registration, - Medical Device Listing, - Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA), - Investigational Device Exemption (IDE) for clinical studies. - MEDICAL Devices - Diagnostic equipment includes medical imaging machines, used to aid in diagnosis. Examples are ultrasound and MRI machines, PET and CT scanners, and x-ray machines. Treatment equipment includes infusion pumps, medical lasers and LASIK surgical machines. - Home Use Devices - Safety & Efficacy - Medical devices that are authorized by the FDA for over-the-counter purchase that are not otherwise restricted and are appropriately described and labeled, such as: - Adhesive bandages - Crutches - Eyeglass frames - Otoscopes - Personal Sound Amplification Products (PSAPs) - Sharps containers ______ Make sure to subscribe to get the latest episode. Contact Us: Pharmacy Benefit News: http://www.propharmaconsultants.com/pbn.html Email: [email protected] Website: http://www.propharmaconsultants.com/ Facebook: https://www.facebook.com/propharmainc Twitter: https://twitter.com/ProPharma/ Instagram: https://www.instagram.com/propharmainc/ LinkedIn: https://www.linkedin.com/company/pro-pharma-pharmaceutical-consultants-inc/ Podcast: https://anchor.fm/pro-pharma-talks
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