FDA Establishment Registration and U.S. Agent Terms
Term, renewal, included consultations, grace period and scope of the FDA Establishment Registration and U.S. Agent service.
Draft pending legal review. This text is not yet the final, binding version.
Scope of the service
The FDA Establishment Registration and U.S. Agent service (“the Service”) includes, according to the accepted proposal:
- assessing the type of registration that applies to the facility (food, cosmetic or drug establishment);
- preparing and submitting the registration to the FDA on the Client’s behalf;
- delivering the confirmation and registration number to the Client;
- the U.S. Agent service when the facility is foreign and it is contracted;
- verification support and necessary updates within the contracted scope.
The Service is grounded in the CFR, FDA requirements and applicable regulation. Registration does not constitute FDA approval of the facility or its products.
Term
- The Service is valid for 12 months from payment.
- The U.S. Agent service is valid for 12 months, independent of the official FDA cycle and of December 31.
Included consultations
During the term, the Client may ask unlimited questions within the contracted scope. Topics outside the scope are quoted separately.
Consultation credit
If the Client paid for a 60-minute Regulatory Consultation and then contracts FDA Establishment Registration, the amount of that consultation is credited to the Service, according to the commercial decision in force. [Pending: term and rules for applying the credit.]
Renewal
When the term ends, the Service may be renewed with a renewal at 62%. This condition applies only to FDA Establishment Registration with U.S. Agent and does not extend to other Access FDA services. The renewal at 62% is not a discount.
[Pending: exact monetary base on which the renewal at 62% is calculated.]
Grace period
The Client has a 21-day grace period to renew.
- [Pending: event that starts the grace period and effects when it ends.]
- [Pending: suspension and reinstatement rules for the Service and the U.S. Agent.]
Registration numbers and documents
Registration numbers belong exclusively to the identified entity, establishment or product and may not be assigned, resold or used for another entity. Private documents issued by Access FDA state their private nature and are not presented as issued or approved by the FDA without express official support.
Client obligations
The Client provides accurate and complete information about the facility, its owners or operators and its activity, and reports any change promptly. Access FDA is not responsible for consequences of inaccurate or outdated information.
Payments
Payments are non-refundable, as a commercial decision, without prejudice to any rights applicable law grants the Client. The General Terms of Service also apply.
Limits
Access FDA does not promise acceptance of products at the border or border crossing, which depend on the authorities and on each product’s compliance.