Earlier when we discussed regulations we said that regulations have the force of law. This means that law enforcement has the ability to enforce the regulations. The objective of FDA regulatory programs is to assure compliance with the FD&C. The FDA has federal enforcement officers that have the authority to enforce compliance within their ranks. Specific enforcement activities include actions to correct and prevent violations, remove violative products or goods from the market, and punish offenders. The type of enforcement activity the FDA uses will depend on the nature of the violation.

As part of the enforcement activities, the FDA regularly inspects facilities to ensure compliance. The purpose of these visits is to verify compliance with all relevant regulations. The FDA performs four different types of inspections: pre-approval, routine, compliance follow-up, and for cause. While the purpose of each type of inspection is to protect the public from unsafe products, the focus and expectations are different.

Pre-approval inspections are conducted after a company submits an application to the FDA to market a new product. These inspections focus on verifying data included in the application and confirming that the facility is capable of manufacturing said product. Inspectors will recommend for or against FDA approval.

Routine inspections are mandated by law every 2 years for class II and class III medical device manufacturers. They follow a prescribed method known as Quality System Inspection Technique (QSIT). If a serious public health risk is identified during a routine inspection, the inspection may become a for cause inspection.

Compliance follow-up inspections review actions taken by a manufacturer in response to a previous inspection that resulted in significant observations or a warning letter. A compliance follow-up is conducted to verify the adequate correction of previous violations, to document continuing violations, or to support future regulatory action.

For cause inspections investigate a specific problem that has been reported to FDA. The source of the report can be the manufacturer, consumer/user complaints, or even a disgruntled employee. A for cause inspection will focus on the particular issue, but can branch out to cover unrelated elements of the firm’s operations as they are uncovered. These inspections are more in-depth than routine inspections and they may not follow a QSIT approach.

Learning Objectives:

- 1.1 - Describe the role of the FDA and other regulatory bodies in the manufacturing of medical devices.