About FDA
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What does ‘recall’ mean?
Recall means a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery. 21 CFR 7 provides guidance so that responsible firms may conduct an effective recall.
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- What is the difference between FDA-listed, 510(k) exempt, cleared and approved medical devices?
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- 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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