Here is a 262 word response discussing the purpose of FDA's Sections 806 and 820 of Title 21:
The purpose of Section 806 of Title 21 is to allow individuals to anonymously report information relating to potential violations of the Food, Drug and Cosmetic Act that may put the public's health at risk. This provides a confidential avenue for reporting concerns about regulated products without fear of company retaliation. Information reported under Section 806 prompts FDA investigation into the validity of the allegations. If verified, it can lead to regulatory and enforcement actions to resolve the identified issues. I unfortunately do not have any first-hand experience with Section 806 reporting processes.
Section 820 pertains to the FDA's Quality System Regulation which outlines current Good Manufacturing Practice (cGMP) requirements for medical device production and quality assurance. It aims to ensure medical devices are designed, produced, handled, and monitored according to rigorous quality standards and specifications. This is vital for guaranteeing the safety and effectiveness of medical devices. Section 820 covers elements such as design controls, purchasing controls, production process controls, acceptance activities, device labeling, and record keeping. I have 3 years of experience working as a Quality Engineer for an FDA-registered contract manufacturer of Class II and III medical devices. In this role, I was directly involved in site compliance with Section 820 requirements, including supplier management, document control, design review, risk management, and CAPA. I conducted internal audits and supported external audits from notified bodies and customers.
In summary, Sections 806 and 820 are critical FDA regulations focused on protecting public health - one related to defect reporting and the other to medical device quality assurance. My experience is on the Section 820 side related to current cGMPs.