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Legal measures

·Written by : administrator   ·Date of writing : 2022-06-13  

The following administrative resolutions or regulations apply to manufacturers, importers, and distributors of domestic and foreign medical devices sold to the United States by FDA in violation of the Federal Food, Drug, and Cosmetic Act (FD&C). It can also be applied to the distributor.

FDA's Legal Actions The following administrative resolutions or regulations apply to manufacturers, importers, and distributors of domestic and foreign medical devices sold to the United States by FDA in violation of the Federal Food, Drug, and Cosmetic Act (FD&C). It can also be applied to exported medical devices and their distributors.

1. Recall by FDA or Voluntary Recall
Recall is the process by which harmful or potentially harmful products are withdrawn from the market or when additional information is needed for the safe use of the product. Recalls can be initiated by FDA or the manufacturer. FDA's Foreign Affairs Department notifies foreign countries of all recalls, including products exported from the United States. However, foreign governments are not obligated to authorize the return of recalled products.

2. Warning Letter
FDA sends a letter to the company stating that if the violations described are not corrected, they can follow a stronger protocol. Warnings can be issued so that violations that pose a serious health risk, or include economic fraud mentioned below, can be corrected immediately, before a stronger code is followed.

3. Subpoena
The subpoena is a formal warning to the company that it intends to sue the company if the violation of the subpoena rule is not corrected. This could give the company an opportunity to convince the FDA not to sue.

4. Sue
action taken by FDA against a company or individual responsible for a violation of the provisions of a previous action.

5. Seizure
A civil action in which the FDA seeks to remove a certain amount of a product from its channels of business. After the seizure, no one can touch it without a legal permission. Plaintiffs or owners of seized goods are usually given 30 days by the court to respond. If no action is taken, the court will order the disposal of the goods. If the owner decides to respond to the government complaint, the case will lead to trial. A third possibility is for the owner of the product to obtain permission in court to act to make the product conform to the regulations. Owners must pay bail to ensure that court orders are carried out, and must also pay for FDA's oversight of the company's actions to ensure that products comply with regulations.

6. Fine
Section 303(f) of the FD&C Act authorizes FDA, after an appropriate hearing, to impose municipal penalties for medical device violations. This fine can be tried in addition to other measures such as recalls, injunctions, confiscations, and prosecutions. In determining the amount, FDA will consider the nature, circumstances, severity, severity, and severity of the violation, the violator's ability to pay, the effect it will have on the violator upon re-establishing business, and a history of previous violations.