California Declaration of Compliance
California Declaration of Compliance
As part of Inspire Medical Systems, Inc.’s (“Inspire” or the “Company”) ongoing efforts in the area of compliance, Inspire has developed a Comprehensive Compliance Program that is designed to comply with applicable federal and state laws and industry standards relating to the marketing and promotion of its products. The Comprehensive Compliance Program is tailored to the nature of Inspire’s business as a medical device manufacturer.
To the best of our knowledge as of the date of this declaration, Inspire is in compliance, in all material respects, with its Comprehensive Compliance Program and with California Health & Safety Code §§ 119400–119402.
Copies of Inspire’s Comprehensive Compliance Program (“CCP”) and this Declaration of Compliance are publicly available on our website and may also be obtained by calling 1‑844‑858‑5771 or by emailing [email protected].
Last updated: May 15, 2026
Comprehensive Compliance Program
Inspire Medical Systems, Inc. (“Inspire” or “Company”) has established a program designed to comply with applicable federal and state laws and industry standards relating to the marketing and promotion of its products. Additionally, Inspire recognizes that adherence to these standards can be furthered through a compliance program that is informed by the Compliance Program Guidance for Pharmaceutical Manufacturers, published by the Office of Inspector General of the U.S. Department of Health and Human Services (the “OIG Guidance”). The OIG Guidance advises that effective compliance programs are comprised of seven elements, which are outlined below. As described below, these elements form the basis of Inspire’s program for compliance with the standards regulating the marketing and promotion of its products.
Written Policies and Procedures
Inspire has written policies and procedures to assure substantial compliance with the applicable laws, regulations and standards governing the marketing and promotion of our products. Inspire has established written policies and procedures that govern activities involving communicating with health care professionals about the appropriate use of our products, including appropriate instruction and education required for the safe and effective use of our products. Inspire also has policies and procedures governing activities involving the advancement of scientific and educational activities supporting medical research and education. These policies and procedures are described further below.
Policy on Educational Grants and Research Grants
Inspire may provide grants for specific educational purposes that benefit health care professionals. These may include, but are not limited to, continuing medical and paraprofessional education programs, fellowships provided to teaching institutions and similar organizations with a demonstrated commitment to scientific and technical education, and programs operated by organizations that provide high-quality, nationally recognized education. Funding of educational programs will generally be provided only to organizations and institutions and not to individual practitioners. Research grants to support physician-initiated research may be provided for programs involving research in areas of legitimate interest to Inspire. All requests are subject to scientific review prior to funding approval.
Policy on Charitable Contributions and Patient Assistance
Inspire will consider charitable contributions and requests for assistance for patients meeting reasonable, verifiable and uniform eligibility requirements.
Policy on Travel Expense Reimbursement for CME, Promotional or Product Training Meetings
Inspire may reimburse attendees for their reasonable travel and lodging expenses associated with attendance at training meetings conducted by Inspire. Training meetings will be conducted in locations conducive to the exchange of information such as educational or conference settings. Where face-to-face health care professionals training is reasonably necessary for the safe and effective use of Inspire products is required, Inspire may provide training at Inspire facilities, at independent teaching centers such as medical institutions, or in other appropriate clinical settings.
Policy on Business Meals
Inspire may occasionally offer a modest meal as part of an educational presentation or a business discussion. Entertainment or recreation at such meetings is not permitted. Attendance by spouses or guests at such meetings is not permitted unless the spouse or guest has a bona fide reason for attending, e.g., they are a health care professional interested in prescribing Inspire product.
Policy on the Provision of Educational and Practice-Related Items
Subject to approval from the Inspire Compliance Officer, Inspire representatives may occasionally provide items that benefit patients or serve a genuine educational function for health care professionals.
Policy Prohibiting Gifts and Entertainment
It is the policy of Inspire not to provide gifts or entertainment (e.g. sporting events, golf outings, concerts, etc.) to health care professionals.
Assigned Compliance Officer
Inspire has a Compliance Officer. Our Compliance Officer is empowered with appropriate authority to exercise independent judgment and has free and unencumbered access to senior management and board of directors. Inspire has a Compliance Committee. The committee is comprised of the Company’s Compliance Officer and members of the Company’s management team.
Training
Inspire has an annual Compliance Training process. New employees receive training at the time of hire and annually thereafter. The training covers applicable guidelines governing our compliance program. Employees are trained on the consequences of failure to comply with the requirements of the Company’s compliance program.
Communication
Inspire encourages open and candid discussion between management and employees regarding any compliance concern. Inspire employees are encouraged to report their concerns to their manager or to the Compliance Officer. Employees also have the option to report potential violations anonymously using the Inspire EthicsPoint Hotline.
Auditing and Monitoring
Inspire self-assesses and periodically audits its compliance with its policies and procedures.
Enforcement and Disciplinary Guidelines
Inspire may take disciplinary action, up to and including discharge/termination, in response to violation of the Company’s compliance policies or procedures. Inspire may conduct an investigation of matters that are brought to the Company’s attention in order to ensure the consistent application of the Company’s standards.
Responses to Detected Problems and Actions to Correct Issues
Inspire requires a prompt and diligent response to potential violations of the Company’s compliance program, including its standards regulating the marketing and promotion of our products. Actions in response to detected problems may include improving policies, procedures, training, communication and monitoring or may require disciplinary action to prevent future violations.
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