Understanding FDA oversight for laser and shockwave devices in chiropractic
What the FDA Does (and Doesn’t Do)
Contrary to common perception, the FDA doesn’t regulate clinicians or how they use therapeutic tools in the clinic. Instead, the agency focuses on medical device manufacturers, regulating how products are labeled, marketed, and brought to market.
Most chiropractic devices fall under Class II medical devices, requiring a 510(k) clearance. This clearance confirms the device is substantially equivalent to one already on the market in terms of safety and effectiveness. But once that device is in your hands, its clinical application falls under your discretion—a space often referred to as off-label use.
Off-Label Use: Legal and Ethical Discretion
Once a medical device is FDA-cleared, it may only be marketed for the specific purposes outlined in its clearance documentation. However, this does not limit a provider’s ability to use the device in other appropriate clinical contexts. This concept, known as off-label use, is well established in both medicine and allied health fields.
As noted in the article, “The FDA itself, along with organizations such as AdvaMed, have published clear guidelines supporting clinicians’ right to use devices off-label when doing so is in the patient’s best interest and within the provider’s scope of practice.”
For example, many Class IV therapy lasers are cleared for increasing circulation and reducing pain and inflammation. These indications can be applied across a broad range of patient presentations—from soft tissue injuries to nerve entrapments—as long as the application aligns with the known biological mechanisms and safety profile of the device.
Don’t Confuse FDA Clearance with CPT Coding or Reimbursement
- FDA clearance affirms a product’s safety and intended use.
- CPT codes describe clinical procedures—not devices.
- Reimbursement is determined by the payer and contract terms, not the device's FDA status.
When investing in modalities that will be used on patients, the question is not only ‘Does it work?’ but also ‘Is it cleared, validated and defensible?
FDA Clearance Supports Risk Management
Beyond marketing and billing, FDA clearance protects your practice.
If a patient injury or adverse event arises, malpractice insurers and licensing boards will often scrutinize whether the equipment in use met FDA standards. Using non-cleared devices may jeopardize liability coverage, even if the therapy itself was well-intended. This is especially important in today’s landscape, where malpractice insurers and state boards increasingly require FDA-cleared devices for coverage and scope validation.
Why it matters for ethical, scalable practice
In today’s integrative care landscape, chiropractic modalities must do more than deliver results—they must also meet ethical, legal, and regulatory expectations. Dr. Christopher M. Proulx, VP of Clinical Affairs at Medray, emphasizes the importance of due diligence when adopting new tools. As he writes, “When investing in modalities that will be used on patients, the question is not only ‘Does it work?’ but also ‘Is it cleared, validated and defensible?’”
FDA clearance plays a critical role in supporting that defensibility—impacting everything from patient trust and clinical documentation to insurance interactions and malpractice coverage.
Key Takeaways:
- The FDA regulates devices and manufacturers—not clinical application.
- Off-label use is legal and ethical when it aligns with safety protocols and patient benefit.
- FDA clearance supports marketing, billing justification, and liability protection.
- Reimbursement decisions are made by insurance carriers, not the FDA.
- Clinicians must connect device selection with treatment intent, documentation, and outcomes.
Further Reading
Further Reading
Dr. Christopher M. Proulx expands on the role of regulatory oversight in therapeutic technologies in his recent feature for Chiropractic Economics. His in‑depth discussion highlights why FDA clearance is essential for safety, defensibility, and modern clinical decision-making.
Explore our Class 4 Lasers and Shockwave Therapy Device
Laser
Explore Medray’s Class 4 Chiropractic Lasers
Medray’s chiropractic Class 4 therapeutic lasers are designed to support circulation, tissue stimulation, and pain relief through a streamlined, repeatable workflow. Discover how laser therapy integrates seamlessly into busy clinics while providing a contact-free option for sensitive presentations.
Shockwave
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Educational content is for licensed healthcare providers and may include discussion of clinical uses not cleared by the FDA. Provided for scientific exchange and not intended as promotional.