(a) Identification. A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves.

(b) Classification. Class II (special controls). The special controls for this device are:

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

(2) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device.

(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Mechanical performance;

(ii) Electrical stimulation parameters; and

(iii) Battery performance.

(4) Performance testing must support shelf life by demonstrating continued device functionality over the identified shelf life.

(5) Software verification, validation, and hazard analysis must be performed.

(6) Labeling must include:

(i) Specific instructions regarding safe placement and correct use of the device;

(ii) Warning(s) against use by patients with active implanted medical devices; and

(iii) A shelf life.

[87 FR 34166, Apr. 5, 2022]