As chiropractic care continues to evolve, the technologies used in clinical practice should meet or exceed accepted standards for performance, compliance and credibility.
As you adapt increasingly sophisticated modalities, from laser therapy and shockwave to electrical stimulation, understanding how these technologies are regulated is essential. While clinical outcomes and patient satisfaction often guide adoption, oversight by the US Food and Drug Administration (FDA) provides a foundational safeguard that many DCs may overlook.
FDA clearance is not simply a regulatory checkbox; it is a signal of a product’s safety profile, intended use and the validity of the claims made around it.
What the FDA actually does and doesn’t do
The FDA does not regulate healthcare providers or determine how individual clinicians apply therapeutic tools. Instead, the agency regulates medical devices and their manufacturers. Specifically, the FDA oversees how products are classified, labeled, marketed and manufactured. Any device intended for medical purposes, including for diagnostic or therapeutic use, must fall within this framework.1
The most common classification for chiropractic modalities, such as therapeutic lasers or shockwave systems, is Class II, which requires a 510(k) clearance. This process demonstrates a device is “substantially equivalent” in safety and effectiveness to an already legally marketed device.2 This distinction is critical. While the FDA provides oversight for the marketing and manufacturing of medical devices, it does not restrict off-label clinical use. That discretion lies with the licensed healthcare provider, which opens a dialogue around clinical application, ethics and liability.
Clinical use vs. labeling: The off-label landscape
Once a medical device is FDA cleared, it may only be marketed for the specific indications outlined in its clearance documentation. However, this does not limit a provider’s clinical discretion to use the device in other appropriate contexts. This principle, commonly referred to as off-label use, is well-established in both medicine and allied health fields. 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.3
For example, many therapeutic lasers are cleared for increasing circulation and reducing pain and inflammation. You may apply these tools to a wide range of conditions, from soft tissue injury to nerve entrapments, provided their intent aligns with the known biological mechanisms and safety profile of the device. This distinction between labeling and application allows for innovation in clinical settings, provided that safety, documentation and patient consent are maintained.
The reimbursement disconnect: CPT coding and FDA clearance
There is often confusion surrounding FDA clearance, CPT coding and insurance reimbursement. These are three distinct domains that do not always align.
A CPT code is a descriptor of how a service is rendered, not a guarantee of coverage or a measure of FDA compliance. For instance, CPT 97039, a common code used for “unlisted modality,” may be applied to emerging technologies that do not yet have a designated code.4
The presence of an FDA-cleared device does not automatically lead to reimbursement. In fact, insurance carriers maintain discretion over what they cover, how much they reimburse and whether preauthorization is required.5 What FDA clearance does offer is documentation that the device meets basic standards of safety and efficacy. This can be helpful when submitting claims or appealing denials, especially when the modality is used to achieve outcomes tied to functional improvement or pain reduction.6
Risk management: Protecting your practice and your patients
Beyond marketing and reimbursement, FDA clearance provides another layer of protection: professional liability insulation.
Malpractice insurers, including large national carriers, may recommend if not require therapeutic devices to be FDA-cleared or approved for medical use to qualify for coverage under standard practice policies. Using non-cleared devices may expose providers to denied coverage or weakened legal defenses if an incident arises, especially if under normal standards or circumstance the device used is otherwise considered a medical device and should be something FDA-approved, cleared or registered.
Additionally, many state boards look to FDA status when investigating scope-of-practice questions or evaluating the legitimacy of tools used in patient care. In short, FDA clearance not only supports clinical decision-making, it can also mitigate regulatory and legal exposure.
Why It matters for ethical, scalable practice
In the context of growing demand for chiropractic services and integrative care, the modalities used in practice must reflect ethical, evidence-based choices. This includes more than just results; it involves how the tools are represented, sourced and documented. DCs are often innovators and early adopters. But they must balance this spirit with regulatory awareness to ensure growth does not outpace governance. 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?” Moreover, as insurance models shift and private-pay practices grow, patient perception matters. Consumers are increasingly educated, and visible FDA clearance often serves as a trust signal, influencing both clinical satisfaction and patient retention.7
Clinical insight
The CPT code selected reflects not just what was done, but why it was done. If the code describes a therapy intended to reduce inflammation and increase circulation, the device used should perform those functions; and ideally be FDA-cleared for those indications. This ensures alignment between application, documentation and reimbursement. Clinicians must be able to connect the dots: device → intent → outcome → justification.8
Key points
- The FDA regulates manufacturers, not how clinicians apply devices in practice.
- CPT codes describe clinical procedures, not specific devices or brands.
- FDA clearance is essential for risk management and may be a malpractice requirement.
- Reimbursement is dictated by payors and contract terms, not clearance alone.
- Clinicians have flexibility to use cleared devices off-label within ethical and legal bounds.
Final thoughts
The landscape of chiropractic care is expanding, and with it comes responsibility. Using FDA-cleared devices is good from a marketing standpoint, but it’s also about establishing a standard of care to support positive outcomes, ethical practice and legal protection.
Incorporating new technologies should always involve due diligence. DCs are entrusted with their patients’ musculoskeletal health as well as with making informed, regulated choices about the tools they use. FDA oversight may not dictate what happens in the treatment room, but it certainly supports what happens next.
Christopher M. Prolux, DC, PHD, CSCS, is a doctor of chiropractic and sport scientist with advanced training in clinical neuroscience, exercise physiology and conservative sports medicine. He has authored peer-reviewed articles and lectures nationally on therapeutic technology integration, injury recovery models and evidence-based rehabilitation. Proulx is currently the Vice President of Clinical Affairs and Strategy for Medray Laser and Technology.
References
Device classification panels. US Food and Drug Administration. https://www.fda.gov/medical-devices/classify-your-medical-device/device-classification-panels. Accessed August 29, 2025.
The 510(k) program: Evaluating substantial equivalence in premarket notifications [510(k)] Guidance for industry and Food and Drug Administration staff. https://www.fda.gov/media/82395/. Accessed August 29, 2025.
Principles on responsible sharing of truthful and non-misleading information about medical technologies with healthcare professionals and payers. AdvaMed. www.advamed.org. Accessed August 29, 2025.
CPT Professional Edition 2024. American Medical Association. AMA Press; 2023.
Medicare coverage database. Centers for Medicare and Medicaid Services. https://www.cms.gov/medicare-coverage-database/. Accessed August 29, 2025.
Top legal risks related to use of medical devices in practice. MedPro Group. Accessed August 29, 2025. https://www.medpro.com. Accessed August 29, 2025
Medical device oversight and safety monitoring. Office of Inspector General. oig.hhs.gov. Accessed August 29, 2025.
General wellness: Policy for low-risk devices. US FDA. https://www.fda.gov/media/90652/download. Accessed August 29, 2025.
