About FDA
FDA Basics: Medical Devices
FDA Basics
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Companies that design, manufacture, repackage, relabel, and/or import medical devices into the United States are regulated by FDA's Center for Devices and Radiological Health (CDRH). |
The owner of the device/product could have designed it but then had it manufactured by a contract manufacturer.
Do You Know…
What It Means When FDA "Clears" or "Approves" a Medical Device?
When FDA review is needed prior to marketing a medical device, FDA will either "clear" the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA, or More...
FDA Basics Videos
Watch a video about diagnostic tests and personalized medicine |
Alberto Gutierrez, director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health on new diagnostic tests and personalized medicine. Watch FDA Basics Videos... |
Medical Device Basics
What is a medical device? Does FDA regulate medical devices? Do I need a prescription for a medical device? Who can write a prescription for a medical device? What is the difference between FDA-listed, 510(k) exempt, cleared and approved medical devices? Are medical devices regulated for non-medical reasons?
Information About Devices
How can I find out if a medical device is cleared or approved? Can you tell me when a medical device will be cleared or approved in the future? Can you tell me how the submission of a medical device application is going? How can I find out if my medical device has been recalled? Who can I contact if my question wasn’t answered or I have additional questions in the future?
Safety
How can I get information about the safety of a medical device after it has been cleared or approved? If I have a concern about a medical device, can I send it to FDA to be tested? What does ‘recall’ mean? What does a recall mean for an implanted device? What should I do if I am hurt by a medical device or if a medical device doesn’t work properly? I am a patient and would like to participate in a clinical study for a new device or procedure. How can I find out more about the study?
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