Title: The Medical Device Enforcement Structure
Course: PW-Course-Import-Test > Section: Module 1: Introduction to Medical Device Quality Systems

Module 1

This section will provide information about how the FDA manages industry compliance to the multitude of regulations that exist in the Code of Federal Regulations (CFR). For this class, we are focused specifically on compliance with 21 CFR 820. The FDA has created 21 CFR 820 (QSR) to provide standardized regulations to industry. There are consequences for non-compliance.

Watch

Watch the narrated presention Consequences of Non Compliance for a general overview of the consequences of non-compliance and enforcement actions.

Now explore these concepts in more detail with the following readings and videos.

Compliance Actions and Activities

Read

Industry is responsible for compliance to 21 CFR 820 as a condition of approval to market medical devices in the United States.

Read about the Compliance Actions and Activities.

If Industry does not comply, enforcement actions can and will be imposed by the FDA. In fact, the primary method of compliance oversight is through Enforcement Actions. Enforcement Actions are applicable for products that are currently marketed in the United States. For example, the FDA is responsible for approval of medical device applications 510(k) and enforcement of the regulation.

Watch

Watch Basics of 510(k) Clearance Process to see one example of approval and enforcement of the regulation.

Basics of 510(k) Clearance Process

How does the Enforcement Structure work?

Read

Enforcement of the regulation begins with FDA Inspection of Medical Device manufacturers to assess compliance to the regulations. The FDA may utilize the Quality System Inspection Technique (QSIT) when inspecting Medical Device companies.

Read Form FDA 483 and Quality System Inspection Technique (QSIT) to learn more about the technique.

Site level inspection observations are documented on Form 483 and subsequently captured in the Inspection Database.

Explore the Inspection Database

As a result of the inspection, medical device manufacturers may be cited by the FDA for infractions against the regulation. The FDA publishes information regarding enforcement actions on the FDA website. This information can be accessed at any time and sorted/viewed to provide information to the medical device community about what areas of the regulation are being cited for non-compliance most frequently.

Explore Inspection Observations.

If corrective actions or timeliness to make required corrections are unsatisfactory (in the eyes of the FDA) further enforcement action may be implemented. The next step in the enforcement process is a Warning Letter. Warning letters are also made available on the FDA website.

Read FDA Warning Letter and Types of Warning Letters on the FDA Website to learn more about this step in the process.

What are the consequences of non compliance to 21 CFR 820?

Read

The consequences for non compliance to 21 CFR 820 may be significant. The following example illustrates the consequences of failure to comply with the regulation.

Read 28 years for salmonella