Pro Pharma Talks

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 b