The FDA oversees each recall to make sure that the company's actions are adequate to protect the public health. During a medical device recall, the FDA works with the recalling company to obtain information about the product, the problem, the recall strategy, and steps to prevent the problem from happening again; the FDA audits to confirm that recall efforts are appropriate and effective; the FDA makes sure the company takes necessary actions to prevent the problem from occurring again.
What happens in a medical device recall?
The FDA oversees each recall to make sure that the company's actions are adequate to protect the public health. During a medical device recall, the FDA works with the recalling company to obtain information about the product, the problem, the recall strategy, and steps to prevent the problem from happening again; the FDA audits to confirm that recall efforts are appropriate and effective; the FDA makes sure the company takes necessary actions to prevent the problem from occurring again.