Imp Dates

Question 1

Before when, are investigations commenced before ……..are not subject to IRB approval? (Date)

Answer 1

Any investigation commenced before July 27, 1981 and was not otherwise subject to requirements for IRB review under Food and Drug Administration regulations before that date.

Question 2

Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after (……) are intended to be legally binding equivalent of traditional handwritten signatures.

Answer 2

August 20, 1997

Question 3

Transisitional device is a device subject to 520(l) of the act that is a device that FDA considered to be a new drug or antibiotic before …..

Answer 3

MAY 28 1976