What is a FDA complaint?

FDA 820.3 (b) Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness,or performance of a device after it is released for distribution.

What is the FDA Compliance and enforcement program?

Compliance and Enforcement FDA closely monitors retailer, manufacturer, importer, and distributor compliance with Federal tobacco laws and regulations and takes corrective action when violations occur. FDA takes a 3-pronged approach to help industry comply with the law by: developing and providing compliance training and education

What is the difference between ISO and FDA complaint?

FDA 820.3 (b) Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness,or performance of a device after it is released for distribution. The ISOdefinition borrows from the FDAall but

What is FDA education and training?

A series of educational activities featuring FDA experts, focused on the safe use of drugs and medical products. Presents opportunity for real-time question and answer session on draft guidances under development. Continuing Education and Training opportunities for healthcare professionals, industry, consumers, and academia.