If an FDA approval says the following for treatment with a medical device, does this mean a doctor absolutely cannot treat a patient (with any of the conditions) with the device? Or does it just mean be cautious?

"Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 18; or for patients with progressive, systemic neurological diseases."

1 Answer 1


It means what it literally says, that safety and effectiveness have not been established in certain contexts. The rationale behind saying this is §201.57 of 21 CFR 201, a regulation that mandates giving warnings. It is permitted to use a device or prescribe a substance where it is not yet proven that it is effective or safe for that usage, but you must not imply that it is perfectly safe and effective in all contexts. This part of the federal regulations dictates language aimed at particular scientific uncertainties. Insofar as a patient is expected to give informed consent for a treatment, informing the patient that a treatment is to some extent unproven is an essential part of the information that must be given for informed consent. So you can interpret it as a flag to the patient (or the prescribing doctor) that there is greater risk.

  • One thing I recently learned is that some insurance companies will put "not medically necessary" for these conditions of safety and effectiveness, even though the FDA did not explicitly say that. Then the surgery, drug or medical device will not be covered. And the patient will likely think they are not eligible for it, even though they would be. Feb 10, 2022 at 22:42

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