Non-Device Clinical Decision Support under Section 520(o)(1)(E) of the FD&C Act
Based on analysis using the FDA's Digital Health Policy Navigator, MVP Rad DEXA meets all four criteria for Non-Device Clinical Decision Support. It is not classified as a medical device and is not subject to FDA premarket review requirements.
MVP Rad DEXA reads pre-extracted T-scores and BMD values from DEXA exam results, applies published WHO diagnostic cutoffs, and generates recommended report template text. Key characteristics:
Each step below follows the FDA Digital Health Policy Navigator decision tree.
Answer: YES → Routes to Step 2
MVP Rad DEXA is intended for use in a clinical setting to assist with radiology report documentation related to bone density assessment.
2.A: NO — 2.B: NO → Routes to Step 3
The software generates clinical report text, not administrative or billing content.
3.A: NO — 3.B: NO → Routes to Step 4
The software is used in a clinical diagnostic workflow, not for general wellness or fitness purposes.
4.A: NO → Routes to Step 5
The software does not function as an electronic health record system. It generates draft report text that the radiologist copies into their reporting system.
5.A: NO → Routes to Step 6
The software does not transfer, store, convert, or display data from a medical device. It works with pre-extracted numerical values entered by the user.
6.A — Does the software acquire, process, or analyze medical images or signals?
NO. MVP Rad DEXA reads pre-extracted T-score values. It does not process DICOM images, raw scan data, or any medical signals.
6.B — Does the software display medical information communicated between HCPs?
YES. The software displays T-scores and categorization data that a radiologist uses in reporting.
6.C — Does the software provide recommendations rather than a specific output or directive?
YES. The software generates recommended template text with placeholder brackets that the radiologist must review, complete, and may modify or reject entirely.
6.D — Does the software provide sufficient basis so the HCP does not rely primarily on the recommendations?
YES. The software displays the underlying T-scores, BMD values, and WHO cutoff criteria used to generate the template. The radiologist can independently verify the categorization.
→ RESULT: LIKELY NOT A DEVICE (Non-Device CDS)
Examples of generated template text. Note the [ ] placeholder brackets that the radiologist fills in.
IMPRESSION:
Bone mineral density is within normal limits.
Lumbar spine T-score: [VALUE]
Femoral neck T-score: [VALUE]
WHO Classification: Normal
Recommended follow-up: [INTERVAL per clinical judgment]
FRAX 10-year fracture risk: [RADIOLOGIST TO ENTER]IMPRESSION:
Bone mineral density is consistent with osteopenia.
Lumbar spine T-score: [VALUE]
Femoral neck T-score: [VALUE]
WHO Classification: Osteopenia (low bone mass)
Comparison to prior: [DATE] — [PERCENT CHANGE]
Recommended follow-up: [INTERVAL per clinical judgment]
FRAX 10-year fracture risk: [RADIOLOGIST TO ENTER]IMPRESSION:
Bone mineral density is consistent with osteoporosis.
Lumbar spine T-score: [VALUE]
Femoral neck T-score: [VALUE]
WHO Classification: Osteoporosis
Comparison to prior: [DATE] — [PERCENT CHANGE]
Recommended follow-up: [INTERVAL per clinical judgment]
FRAX 10-year fracture risk: [RADIOLOGIST TO ENTER]
Consider: [RADIOLOGIST CLINICAL RECOMMENDATIONS]This analysis is based on publicly available FDA guidance and the FDA Digital Health Policy Navigator tool as of March 2026. It does not constitute legal advice. Regulatory classifications may change as FDA guidance evolves. Companies should consult with a qualified regulatory affairs professional or legal counsel for their specific product.
MVP Rad DEXA is a documentation and workflow productivity tool. It does not interpret medical images or provide diagnostic conclusions. All clinical content and final reports are the responsibility of the licensed clinician.