FDA Forms Flashcards
1
Q
What is Form 482?
A
Notice of Inspection
2
Q
What is Form 483?
A
Inspectional Observations
3
Q
What is Form 1572?
A
Statement of Investigator
4
Q
What is Form 3454?
A
Certification: Financial Interests and Arrangements of Clinical Investigators
5
Q
What is Form 3455?
A
Disclosure: Financial Interests and Arrangements of Clinical Investigators
6
Q
What is Form 3500?
A
MedWatch: For VOLUNTARY reporting of AEs, product problems, and product use errors
7
Q
What is Form 3500A?
A
MedWatch: For use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting
