Disclaimer
 
High-integrity regulatory support—without creating unintended legal or compliance reliance.
This Disclaimer governs your use of this website operated by Beacon Regulatory Services (BRS) LLC (“BRS LLC,” “we,” “us,” “our”). It clarifies the boundaries of informational content, service descriptions, and communications so expectations remain aligned and audit-ready. For related governance, see the Privacy Policy and Terms of Use.
Effective date: December 17, 2025  • We may update this Disclaimer as services, tooling, and regulatory expectations evolve.
 
 
  • Scope & purpose
    Content on this website is provided for general informational purposes to describe BRS LLC’s services and to share practical perspectives on regulatory operations, FDA registration and listing, and related compliance topics. It is not intended to be exhaustive, device-specific, or a substitute for a tailored regulatory strategy.
  • No legal advice; no attorney-client relationship
    BRS LLC is not a law firm, and communications on this website do not constitute legal advice. Using this website, submitting an inquiry, or requesting information does not create an attorney-client relationship. If you require legal counsel, consult qualified legal professionals in the applicable jurisdiction(s).
  • No regulator endorsement; no guarantee of outcomes
    References to FDA, CDRH, or other regulatory authorities are for informational context only and do not imply endorsement, sponsorship, affiliation, or approval of BRS LLC. Regulatory outcomes depend on device specifics, labeling, intended use, quality system maturity, and regulator review; therefore, outcomes cannot be guaranteed.
  • Accuracy, timeliness, and regulatory change management
    Regulatory expectations, guidance, standards, and enforcement posture evolve. While BRS LLC aims to keep information current and operationally useful, we do not warrant that website content is complete, current, or error-free at all times. You are responsible for validating applicability to your device(s) and situation, including confirming current requirements with competent resources and, where appropriate, regulatory authorities.
    Operational expectation
    Treat website content as a starting point for scoping and governance—not as a substitute for a documented regulatory plan, decision rationale, and controlled records.
  • Third-party links and content
    This website may reference or link to third-party sites (including regulators, standards organizations, vendors, and resources) for convenience. BRS LLC does not control and is not responsible for third-party content, availability, or practices. A link does not constitute endorsement.
  • Limitation of liability
    To the maximum extent permitted by applicable law, BRS LLC disclaims liability for any direct, indirect, incidental, consequential, special, or punitive damages arising from or related to your use of this website or reliance on its content. This includes, without limitation, damages for lost profits, lost data, business interruption, or compliance impacts. If you engage BRS LLC for services, applicable limitations and responsibilities will be governed by the executed service agreement(s).
  • Questions or requests
    If you have questions about this Disclaimer or want to confirm scope boundaries before engaging, contact:
    Beacon Regulatory Services (BRS) LLC
    9105 E 56th St, Ste J #2057, Indianapolis, IN 46216, United States
    Phone: +1 (317) 662-0910
    Email: This email address is being protected from spambots. You need JavaScript enabled to view it.  or  use the contact form
    For consolidated governance navigation, see Legal & Privacy.
 
 
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