Legal
Terms of use
Terms that apply to your use of this website.
Effective September 12, 2026
Who we are
This website is operated by Cardiovascular Regulatory Advisors, Inc., a Delaware corporation ("CVRA", "we"). By using it you accept these terms.
Information, not advice
The content on this site, including the notes published under Insights, is general information about the United States regulatory process for medical devices. It is not regulatory, legal, or professional advice for any particular device or program, and you should not act on it without advice specific to your situation.
CVRA is a regulatory consulting firm. It is not a law firm and does not provide legal advice. It is not affiliated with, endorsed by, or acting on behalf of the U.S. Food and Drug Administration.
No engagement without an agreement
Using this site, submitting the contact form, or corresponding with us does not create a client relationship. An engagement exists only when both parties have signed a written agreement. Until then, please do not send us confidential technical information.
No guarantee of outcomes
Decisions on submissions, studies, and inspections are made by FDA and other authorities. Nothing on this site is a promise of any regulatory outcome or timeline.
Intellectual property
The text, design, illustrations, and logos on this site belong to CVRA or are used with permission. You may read and link to the site. You may not reproduce its content for commercial purposes without our written consent.
Limitation of liability
The site is provided as is. To the extent permitted by law, CVRA is not liable for any loss arising from your use of the site or your reliance on its content.
Governing law
These terms are governed by the laws of the state in which CVRA is incorporated and of the United States, without regard to conflict of law principles.
Changes
We may update these terms and will post the current version on this page with a new effective date.