“Who is responsible for the safety of medical devices?” is a common question we get. Watch our video below to learn more about the FDA’s responsibility for medical devices and more.
0:14 Responsibility For Medical Devices
0:49 Federal Drug Administration
0:14Who Is Responsible For The Safety Of Medical Devices? Responsibility For Medical Device
The answer is everybody, and when I say everybody, from the manufacturer to the distributor to the FDA who has to prove it to the person who uses it. You’ve got to use it properly, and so everybody’s responsible for ensuring that these products are used safely.
0:49 Federal Drug Administration Responsibility for Medical Devices
Obviously, during the testing, the research, and development, there are very specific criteria that have to be met by the designers, by the manufacturers of the product in order even before they take it to the FDA, the Federal Drug Administration, in order to be approved, to be tested, and put out in the market. Then obviously, the FDA has to go through the proper steps in order to vet and to make sure that what’s been presented by the manufacturers is something that they are comfortable with selling to the public.
The distributors as well, just because you have a product and putting it out there making money doesn’t mean that you don’t have to exercise common sense. If you see people having problems, you have a duty to report it so that people can investigate, so the distributors have some responsibility also.
Then lastly, we have a responsibility if you get a machine that you’re supposed to use a particular way, use it that way, follow the instructions. If you don’t do what you’re supposed to do and things go bad, well, you can’t blame the manufacturer, you can’t blame the FDA. You have to blame yourself.
It’s a collective responsibility for ensuring that the equipment that we use to help ourselves medically is safe and proper, and used without a whole lot of catastrophe.
If you or your loved one has been permanently or seriously injured due to a defective medical device contact the Medical-Legal team at LawMD.
More than 10 of our lawyers are also physicians.
For serious injuries, LawMD is the right medicine for justice.