Code of Federal Regulations Title 21. Food and Drugs § 21.26.75 Suspension of recognition obligations

(a) A party suffers a loss of market access for the party's products within the scope of subpart A or B of this part as a result of the failure of the other party to fulfill its obligations under this part;

(b) The adoption of new or additional conformity assessment requirements as referenced in § 26.73(e) results in a loss of market access for the party's products within the scope of subpart B of this part because conformity assessment bodies (CAB's) designated by the party in order to meet such requirements have not been recognized by the party implementing the requirements;  or

(c) The other party fails to maintain legal and regulatory authorities capable of implementing the provisions of this part.