Does FDA regulate medical devices?
Yes, FDA regulates a broad range of medical devices, including complicated, high-risk medical devices, like artificial hearts, and relatively simple, low-risk devices, like tongue depressors, as well as devices that fall somewhere in between, like sutures. FDA has authority to regulate medical devices before and after they reach the marketplace.
- May Webinar - Hearing Aids: The Basic Information You Need to Know
- July Webinar: Home Use of Medical Devices
- What is the difference between FDA-listed, 510(k) exempt, cleared and approved medical devices?
- What does ‘recall’ mean?
- What is a medical device?
- Who can I contact if my question wasn’t answered or I have additional questions in the future?
- Does FDA regulate these new powerful laser "pointers" and are they hazardous?
- What should I do if I am hurt by a medical device or if a medical device doesn’t work properly?
- What does it mean for FDA to "classify" a medical device?
- What does it mean when FDA "clears" or "approves" a medical device?
- 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?