Code of Federal Regulations Title 21. Food and Drugs § 21.892.5725 Absorbable perirectal spacer

(i) Performance bench testing must demonstrate appropriate perirectal space creation and maintenance for the duration of prostate radiotherapy.

(ii) Performance bench testing must demonstrate that therapeutic radiation levels do not alter the performance of the device.

(iii) Performance in vivo testing must demonstrate appropriate deployment of spacer as indicated in the accompanying labeling, and demonstrate appropriate expansion and absorption characteristics in a clinically relevant environment.

(iv) Clinical study must demonstrate appropriate spacer stability and lack of migration for the entire course of radiotherapy, complete absorption, and lack of long term toxicity.

(v) Sterility testing must demonstrate the sterility of the device and the effects of the sterilization process on the physical characteristics of the spacer.

(vi) Shelf-life testing must demonstrate the stability of the physical characteristics of the spacer throughout the shelf-life as indicated in the accompanying labeling.

(vii) The device must be demonstrated to be biocompatible.

(i) A detailed summary of reported or observed complications related to the use of the device;

(ii) Appropriate warnings;

(iii) Detailed instructions for system preparations and detailed implant procedure instructions;  and

(iv) An expiration date that is supported by performance data as specified in paragraph (b)(1)(vi) of this section.