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The Food and Drug Administration (FDA) is responsible for ensuring that all medical devices are manufactured according to strict safety standards. Audits are used to check in on manufacturers and ensure all production activities are in accordance with the applicable regulations.

The FDA can conduct one of four types of medical device audits, depending on the reason why an audit has been ordered.

1. Pre-Approval Inspections

The first type of audit conducted by the FDA is referred to as a pre-approval inspection.

All medical device manufacturers must apply with the FDA to market new products. Once an application is received, a representative from the FDA will visit the manufacturing site to verify all data submitted in the application.

The FDA representative will certify that the facility is capable of safely manufacturing the product they have applied to market, which will give the manufacturer the ability to begin production.

2. Routine Audits

The law requires that all facilities manufacturing medical devices undergo routine audits. These audits are performed by the FDA using the Quality System Inspection Technique.

The primary purpose of routine audits is to verify the safety of manufacturing processes. Any serious public health concerns that are revealed during a routine audit can result in a shut-down of the facility.

3. Compliance Audits

Whenever a routine audit or a pre-approval inspection reveals issues with the manufacturing process, the FDA will issue a warning letter.

This warning letter will provide detailed instructions regarding the processes that must be revised in order for a facility to retain the ability to produce medical devices.

A specified amount of time will be given for a manufacturer to make any changes required, then a compliance audit will take place.

Compliance audits are used to determine if a manufacturing facility has resolved its issues, or if further disciplinary action is required.

4. For-Cause Audits

The final type of audit performed by the FDA is referred to as a for-cause audit. Employees of the manufacturer, a facility's shipping and retail partners, and the general public all have the ability to report potential issues with a medical device to the FDA.

Once a complaint has been received, the FDA must conduct an audit of the manufacturing company to determine if the complaint is valid.

Valid complaints are taken seriously, and a facility that is found in violation during a for-cause audit will be required to make changes and complete a compliance audit before marketing any medical devices in the future.

Contact a medical device quality system auditing service for more information.