§ 809.5 - Exemption from batch certification requirements for in vitro antibiotic susceptibility devices subject to section 507 of the act.

(a) Antibiotic susceptibility devices subject to section 507 of the act are exempt from the batch certification requirements of part 431 of this chapter if the following conditions are met:

(1) The antibiotic susceptibility device is approved for marketing under an appropriate antibiotic application.

(2) The antibiotic susceptibility device is packaged and labeled for dispensing in accordance with the applicable regulation (monograph) in this chapter except where other labeling has been approved in an applicable antibiotic application.

(3) The bulk antibiotic drug used in preparing the antibiotic susceptibility device meets the standards of identity, strength, quality, and purity specified in the applicable regulation (monograph) in this chapter except where other standards have been approved in an applicable antibiotic application.

(4) The antibiotic susceptibility device meets the standards of identity, strength, quality, and purity specified in the applicable regulation (monograph) in this chapter except where other standards have been approved in an applicable antibiotic application.

(b) For each antibiotic susceptibility device subject to an exemption under this section, an approved antibiotic application is regarded to be an approved premarket approval application under section 515 of the act.

(c) Nothing in this section prevents a manufacturer from applying for batch certification of an antibiotic susceptibility device as provided in section 507(c) of the act.

(d) All exemptions from batch certification requirements for antibiotic susceptibility devices under this section are subject to the conditions of effectiveness under § 809.6.