QUESTION
Can the FDA take regulatory action against a Doctor for misuse of a regulated Medical Device?
Asked on Oct 10th, 2011 on Medical Malpractice - New Jersey
More details to this question:
I had a doctor that was not in compliance with a regulated Medical Device where the regulations are setforth by FDA and Manufacturer Labeling. I wrote to Margaret Hamburg(FDA), regarding this issue. Does she respond? I live in NJ and I sent the same question to the London MRHA. They responded within 1 day.
1 ANSWER
Catastrophic Injury Attorney serving Roseland, NJ
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John J. Ratkowitz
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You may get more satisfaction writing to the NJ board of medical examiners if this harmed you. Nevertheless, off label use is not automatically a breach of accepted standards of care.
Answered on Nov 11th, 2011 at 3:53 PM