Through an audit or inspection, the FDA can determine that a medical device manufacturer is in violation of the Federal Food, Drug and Cosmetics Act (FDCA).
Violations can include inadequate maintenance of the complaint file, improper claims about how the product works, faulty design controls, and other issues. The FDA issues warning letters to companies when there is an indication that a serious violation has occurred.
US FDA warning notice provide a detailed description of specific violations and require an immediate response from the manufacturer describing the corrective action to be taken.
It is important to note that warning letters are only issued for violations of regulatory purposes. This means that they can lead to enforcement action if corrective action is not taken.
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What does the FDA warning letter mean for medical device manufacturers?
For medical device companies, FDA warning letters can delay or prevent prior approval of medical devices. In addition, warning letters are posted on the FDA website to protect patients and encourage manufacturers to take immediate action. In addition, there are several possible legal consequences. FDA warning letter:
It acts as advance notice if the FDA decides to take regulatory action.
This can be introduced as evidence in a product liability case;
This can serve as evidence of the company's knowledge of deficiencies in civil proceedings.
This could be used by plaintiffs to convince jurors that the FDA approved the plaintiff's claim.
Coercive action can be taken if violations are not corrected in a timely and comprehensive manner.