How will FDA enforce this interim final rule during the comment period?
FDA will actively consider the exercise of its discretion in the enforcement of the Prior Notice interim final rule while at the same time ensuring public health protection, both during initial implementation of the interim final rule and thereafter. The Prior Notice interim final rule takes effect on December 12, 2003, and covered entities are responsible for complying with the requirements in the interim final rule at that time. FDA recognizes that a number of affected parties still may need assistance understanding the interim final rule’s requirements and how to comply even after the extensive outreach and educational activities that FDA will be conducting before December 12th. Accordingly, for this and other reasons, FDA intends to put into place, during the initial months following the effective date, a policy that emphasizes assisting covered entities in understanding the requirements and how to comply. FDA will shortly publish a notice of availability for a Compliance Policy Gu
Related Questions
- What is the procedure outlined in the interim final rule (IFR) for petitioning FDA for an exemption from 100 percent identity testing requirement?
- What is the procedure outlined in the Interim Final Rule for petitioning FDA for an exemption from 100 percent identity testing requirement?
- How will FDA enforce this interim final rule during the comment period?
How will FDA enforce this interim final rule during the comment period?