About FDA
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What is a medical device?
A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
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- Who can I contact if my question wasn’t answered or I have additional questions in the future?
- What should I do if I am hurt by a medical device or if a medical device doesn’t work properly?
- What is the difference between FDA-listed, 510(k) exempt, cleared and approved medical devices?
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- How can I find out if my medical device has been recalled?
- Does FDA regulate medical devices?
- How can I find out if a medical device is cleared or approved?
- How can I get information about the safety of a medical device after it has been cleared or approved?
- What does a recall mean for an implanted device?
- If I have a concern about a medical device, can I send it to FDA to be tested?
- Can you tell me how the submission of a medical device application is going?
- Can you tell me when a medical device will be cleared or approved in the future?
- Who can write a prescription for a medical device?
- Do I need a prescription for a medical device?
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