Title: Module 1 Additional Resources
Course: PW-Course-Import-Test > Section: Module 1: Introduction to Medical Device Quality Systems

Module 1

The following resources will help you see how the regulation is being applied in the industry today.

How is information that is collected in FDA investigations made available to the general public?

The FDA collects data from inspection and enforcement activities and makes it available under the general provisions of the Freedom of Information Act. One of the outcomes of making this data available is that industry can stay abreast of current enforcement actions/inspection observations.

The ability to access this data is critical to industry with respect to communicating the state of “current” in the context of cGMP (current Good Manufacturing Practices). (Ref. Preamble)

The regulations do not change frequently. How does the FDA apply innovations in the development of Medical Device Quality Systems when they conduct inspections?

Review this link for facts about Current Good Manufacturing Processes (cGMP). Although this link is related to drugs, which are not covered under 21 CFR 820, the explanation concerning the state of “current” in cGMP is applicable. This link offers the best explanation on the FDA website.

Read about the FDA cGMP requirements for Medical Devices.

The protection of consumer health and safety extends to animals/pets also. Read this example regarding a significant issue with dog treats.