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About
FDA Regulations regarding Medical Devices
Which of the following products does FDA regulate?
- Home pregnancy tests
- X-ray machines
- Implantable defibrillators
- Contact lenses
- Catheters
- All of the Above
Answer:
FDA regulates all of them as medical devices. In fact, FDA
regulates nearly 2,000 kinds of medical devices. If a medical
device is used in your facility and it’s not a drug, vaccine or
blood product, it’s probably a medical device.
(Ref : http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/t)
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