FDA forms

Question 1

Disclosure - financial interest and arrangements of clinical investigators

Answer 1

FDA Form 3455

Question 2

FDA Form 3455

Answer 2

Disclosure - financial interest and arrangements of clinical investigators

Question 3

Statement of investigator

Answer 3

FDA form 1572

Question 4

FDA form 1572

Answer 4

Statement of investigator

Question 5

Notice of inspection

Answer 5

FDA form 482

Question 6

FDA form 482

Answer 6

Notice of inspection

Question 7

Voluntary reporting of AEs and product problems

Answer 7

FDA form 3500

Question 8

FDA form 3500

Answer 8

Voluntary reporting of AEs and product problems

Question 9

Certification - financial interests and arrangements of clinical investigators

Answer 9

FDA form 3454

Question 10

FDA form 3454

Answer 10

Certification - financial interests and arrangements of clinical investigators

Question 11

Inspectional observations

Answer 11

FDA form 483

Question 12

FDA form 483

Answer 12

Inspectional observations

Question 13

For use by user-facilities, distributors, and manufacturers for mandatory reporting

Answer 13

FDA form 3500A

Question 14

FDA form 3500A

Answer 14

For use by user-facilities, distributors, and manufacturers for mandatory reporting

Question 15

FDA form 1572 is part of which FDA regulation

Answer 15

21 CFR Part 312

Question 16

Do all forms have an OMB number and expiration date

Answer 16

No

Question 17

Can a small business seek assistance from the US Small Business Associated after given notice of inspection

Answer 17

Yes