FDA: Identifying a Grandfather Date - LDT 2024, Devices 1976

The grandfather date for devices is May 28, 1976

https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states

Established the regulatory pathways for new medical devices (devices that were not on the market prior to May 28, 1976, or had been significantly modified) to get to market: Premarket Approval (PMA) and premarket notification (510(k))

https://www.govinfo.gov/content/pkg/STATUTE-90/pdf/STATUTE-90-Pg539.pdf

Page 5

)(I) has been introduced or delivered for introduction

into interstate commerce for commercial distribution before the

date of enactment of this section, or

"(II) is within a type of device which was so introduced or

delivered before such date and is substantially equivalent to

another device within that type, 

In the May 6, 2024, FDA LDT regulation, the term "marketed before" is used numerous times, but without further clarification.

FDA intends to exercise 

enforcement discretion and generally 

not enforce premarket review and QS 

requirements (except for requirements 

under part 820, subpart M (Records)) for 

currently marketed IVDs offered as 

LDTs that were first marketed prior to 

the date of issuance of this rule and that 

are not modified, or that are modified in 

certain limited ways as described in 

section V.B.3; 

89FR37295 (and many other places in the same rule)

https://www.govinfo.gov/content/pkg/FR-2024-05-06/pdf/2024-08935.pdf