FDA/ Rx Disclaimer
FDA / Rx Disclaimer
Effective Date: June 23, 2026 | Last Updated: June 23, 2026
Some products sold on this site are intended for licensed healthcare professionals only. Certain products may require verification prior to shipment.
Thomas Jane Medical is an authorized distributor of specialty surgical products and FDA-regulated medical devices. The following disclaimer governs all products sold through thomasjanemedical.com.
1. Healthcare Professional Requirement
Many products available through Thomas Jane Medical are classified as prescription (Rx) medical devices under 21 CFR Part 801 and applicable federal and state laws. These products are:
- Intended for use by or on the order of a licensed physician, surgeon, or other qualified healthcare professional
- Not intended for consumer or general public purchase or use
- Required to bear the statement: “Caution: Federal law restricts this device to sale by or on the order of a physician” (or equivalent)
By purchasing from Thomas Jane Medical, you confirm that you are a licensed healthcare professional, a licensed healthcare facility, or an authorized purchasing agent acting on behalf of such a professional or facility.
2. Credential Verification
Thomas Jane Medical reserves the right to verify professional credentials, facility licensure, or purchasing authority before fulfilling any order for a regulated product. This may include:
- Request for NPI (National Provider Identifier) number
- Facility DEA or state license number
- Proof of employment at a licensed healthcare facility
- Signed attestation of professional status
Orders for Rx or restricted products placed without valid credentials will be held pending verification and may be canceled if credentials cannot be confirmed within 2 business days.
3. FDA Regulatory Status
Products sold by Thomas Jane Medical are FDA- regulated devices. Thomas Jane Medical is a distributor, not a manufacturer and is not responsible for device design and manufacturing. Thomas Jane Medical will follow all FDA regulations and requirements from each manufacturer. All products are sold and labeled and cleared by the manufacturer.
4. Intended Use
All products are sold for their labeled, FDA-cleared intended use only. Thomas Jane Medical makes no representations or warranties regarding off-label use. Healthcare professionals are solely responsible for clinical decisions regarding the use of any product.
5. No Medical Advice
Content on thomasjanemedical.com, including product descriptions, clinical data summaries, and educational materials, is provided for informational purposes only and does not constitute medical advice, diagnosis, or treatment recommendations. Always rely on your clinical training, judgment, and applicable protocols.
6. Adverse Event Reporting
If you experience or observe a serious injury or death potentially associated with a product purchased from Thomas Jane Medical, you are required to report the event to the FDA MedWatch program (1-800-FDA-1088 or fda.gov/safety/medwatch) and to notify Thomas Jane Medical promptly.
To report a product complaint or adverse event to Thomas Jane Medical:
- Email: purchase@thomasjanemedical.com
- Phone: 316-251-0920
- Include: product name, REF number, lot number, expiration date, and description of the event
7. State-Specific Requirements
The sale and distribution of certain medical devices may be subject to additional requirements under state law. It is the responsibility of the purchasing professional or facility to ensure compliance with all applicable state and local regulations governing procurement and use of medical devices.
8. Product Recalls & Safety Notices
Thomas Jane Medical monitors FDA recall databases and manufacturer safety communications. In the event of a product recall or safety notice affecting products you have purchased, we will make reasonable efforts to notify you using the contact information on file. We encourage you to maintain current contact information in your account.
FDA recall information is publicly available at: recalls.fda.gov
9. Limitation
This disclaimer does not limit, and should be read in conjunction with, Thomas Jane Medical’s Terms & Conditions, Return Policy, and Privacy Policy, all of which are incorporated herein by reference.
10. Contact
For questions regarding product regulatory status, credentials, or adverse event reporting:
Thomas Jane Medical
1356 N. Emporia Ave., Wichita, KS 67214
Email: purchase@thomasjanemedical.com
Phone: 316-251-0920
Website: thomasjanemedical.com