FDA clearance is a formal recognition by the US Food and Drug Administration (FDA) that a medical device is licensed for use according to the product label, for example as an aid in the clinical assessment of ADHD and the evaluation of treatment.
When a medical device is cleared, the company is subject to FDA inspections to ensure it is complying with applicable laws and regulations, which protect customers and patients from unsafe products.
Reasons not to use ADHD tests that aren’t cleared by the FDA in your service
Part of the 510(k) submission, manufacturers seeking FDA clearance submit all published and unpublished data that should support the licensed indication. This includes data on sensitivity, specificity, and normative data.
Using a tool that hasn’t demonstrated efficacy and patient safety
The most important of all considerations in the medical field is patient safety. FDA clearance requires manufacturers to demonstrate that their device is as safe and effective as a previously approved device.
It helps to reduce the risk of harm to patients by making sure new devices perform reliably for their intended use.
Using unregulated tests means that the scientific data supporting the test has not been evaluated by the FDA, nor that it is licensed for use in ADHD.
Manufacturers of uncleared tests are not subject to FDA inspection and lack the assurance of quality manufacturing of cleared tests.
Not complying with expectations of insurers
Most payors look for FDA approval or FDA clearance as well as use within the licensed indication before they agree to reimburse the use of a medical device. Regulatory alignment supports a smoother reimbursement process.
Devices without FDA clearance or used outside their licensed indications can create uncertainty and potentially complicate reimbursement. To use a medical device outside its licensed indication could lead to a refusal to reimburse or a claw back from the payor.
What is the difference between FDA approved and FDA cleared?
The most important thing to note about FDA approved and FDA cleared is that one is not more robust than the other.
What differentiates them is that FDA approval is given when a new device has proven to be safe and effective for its intended use, whereas FDA clearance demonstrates that the device is substantially equivalent to a legally marketed device and therefore doesn’t need premarket approval.
What if an ADHD test has FDA exemption?
If an ADHD test has 510(k) exemption, this is not the same as FDA clearance. Instead, it is classified as exempt on the condition that it is not intended as a stand-alone or adjunctive diagnostic device.
Exemption does not apply if the test is intended for diagnostic assessment of specific diseases and relies on inputs from visual cues, auditory cues, and/or functional use of the hand.
An exempt test is of limited value as it cannot be used to aid decisions in ADHD care.
Examples of FDA cleared ADHD tests
Our medical devices QbTest and QbCheck have FDA clearance.
- In 2012, the FDA cleared QbTest (K122149) to aid in assessing individuals with ADHD.
- In 2014, QbTest (K133382) achieved FDA clearance to aid in the evaluation of treatment interventions in children, adolescents, and adults with ADHD.
- In 2016, the FDA cleared QbCheck (K143468) to aid in the assessment and evaluation of treatment interventions in patients with ADHD.
Benefits of FDA cleared ADHD tests
1. Clinical reliability
The FDA clearance process requires a submission of all published studies and unpublished data to make a thorough evaluation of our ADHD test’s performance in clinical settings.
This means that our tests meet the requirements for specificity and sensitivity and are supported by appropriate clinical studies to justify the license indication.
2. Regulatory compliance
Our tests comply with all relevant regulatory requirements. This is crucial for legal and ethical practice, making sure they align with high standards of medical practice.
3. Patient confidence
You, your patients, and your insurers are confident that our tests are legitimate and reliable tools for aiding in the diagnosis and treatment management of ADHD.
4. Greater confidence in decision making
You can identify symptoms of ADHD with accuracy, leading to increased clinician confidence in diagnostic decision making.
5. Continuous attention to standards
Maintaining FDA clearance requires continuous attention to quality standards, encouraging health tech companies to continue to assure the quality of their products.
Get further insight with our case study by a customer who switched to Qbtech from their original tool and learn why gamified ADHD tests can skew your patient’s results.