State of California Compliance Program Declaration
As part of our continued commitment to compliance, Gynesonics, Inc. (“Gynesonics”) has developed and implemented a Comprehensive Compliance Program consistent with the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers, and with applicable state and federal laws relating to the marketing and promotion of the company’s products. The compliance program is designed in accordance with the AdvaMed Code on Interactions with Health Care Professionals, which is substantially equivalent to the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals (PhRMA Code) but reflects the unique interactions between medical technology companies and health care professionals. To the best of our knowledge and based on our good faith understanding of all applicable statutory and regulatory requirements, Gynesonics is in compliance with our Comprehensive Compliance Program and with the requirements of the California Health and Safety Code § 119400-119402. Gynesonics will evaluate and update its Compliance Program, as necessary and appropriate. Gynesonics will make conforming changes to our Comprehensive Compliance Program within six months of any update or revision of the Compliance Program Guidance or AdvaMed Code.
With respect to business activities in California, Gynesonics has established a specific annual dollar limit on educational items and promotional activities Gynesonics may give or otherwise provide to an individual medical or healthcare professional. The annual limit is reevaluated annually, and does not include expenditures for the following:
- Patient educational material provided to patients by their physician with the purpose of educating the patient or enhancing the patient’s understanding or management of the condition.
- Payments for legitimate professional services, and any meals or expenses associated with the provision of such services
- Financial support for travel to attend training and/or for continuing medical education programs
- Financial support for health education scholarships
- Single-use devices and device loan to permit evaluation of the device
Copies of this Declaration and a description of our Comprehensive Compliance Program may be obtained by contacting our Corporate Compliance Department at compliance@gynesonics.com or the Gynesonics corporate headquarters at 844-343-6859.
Dated: February 7, 2025
Gynesonics holds certificate number FM 559780 and operates a Quality Management System which complies with the requirements of ISO 13485:2016 for the following scope:
The Design, Development, Manufacturing, Service, Repair, and Refurbishment of Intrauterine Ultrasound guided RF ablation systems and accessories.
Updated March 25, 2024