Code of Federal Regulations Title 21. Food and Drugs § 21.884.6165 Intravaginal culture system

(i) Comfort and retention of the intravaginal culture device;

(ii) Adverse vaginal tissue reactions associated with intravaginal culture;

(iii) Maximum number of gametes and/or embryos that can be placed in a device;  and

(iv) Rates of embryo development to the designated stage, implantation rates, clinical pregnancy rates, live birth rates, and any adverse events or outcomes.

(i) Mouse embryo assay testing to assess embryotoxicity by evaluating the gamete and embryo-contacting device components effect on the growth and development of mouse embryos to the blastocyst stage;

(ii) Endotoxin testing on gamete and embryo-contacting components of the device;

(iii) Cleaning and disinfection validation of reusable device components;

(iv) Sterility maintenance of the culture media within the device throughout the vaginal incubation period and subsequent embryo extraction;  and

(v) Ability of the device to permit oxygen and carbon dioxide exchange between the media contained within the device and the external environment throughout the vaginal incubation period.

(i) A detailed summary of the clinical testing, including device effectiveness, device-related complications, and adverse events;

(ii) Validated methods and instructions for reprocessing of reusable components;

(iii) The maximum number of gametes or embryos that can be loaded into the device;

(iv) A warning that informs users that the embryo development is first evaluated following intravaginal culture;  and

(v) A statement that instructs the user to use legally marketed assisted reproductive technology media that contain elements to mitigate the contamination risk (e.g., antibiotics) and to support continued embryonic development over the intravaginal culture period.

(i) Relevant warnings, precautions, and adverse effects and complications;

(ii) Information on how to use the device;

(iii) The risks and benefits associated with the use of the device;  and

(iv) A summary of the principal clinical device effectiveness results.