Summary of FDA Final Rule ( 21CFR Part 1100, 1140, 1143)
II. Important dates and deadlines
– FDA Final Rule goes into effect in August 08, 2016
– Register manufacturing establishment(s) and submit product listing to FDA by December 31, 2016
– Initial compliance Period – Premarket application submission to FDA
– Continued compliance period (+ 12 months) to obtain authorization from FDA
What if, an approval for premarket is not received before 36 months?
3- A product will be subjected to enforcement if still in the market
4- FDA, at its discretion to review “Case-by- case” if an application review is close to make decision on the
5- The FDA will give a layaway and may extend the submission period for small manufacturers and company.
Any company or manufacturers that employees 150 and less and/or if the annual gross revenue is 5millions
“Grandfather” Products have been sold in the market before and ON February 15, 2007
FDA does not anticipate that many manufacturers will make such submissions, but this option is available.
Length of period: 12, 18 and 24 months
Length of period 24, 30 and 36 months