Description
Nonprescription (Over-the-Counter or OTC) medical devices and diagnostics, can diagnose (test, screen, monitor), treat, prevent disease or other health conditions. They can be hardware (like tool, instrument, equipment), software (like internal computations, App), or both. They don't require a prescription to purchase and are generally low cost.
Using the SAFEST BRAINS guide, they can help you check, monitor, manage, and support health factors that are directly or indirectly related to brain health - at home, without a doctor visit. Some examples provided below
Infant
EXAMPLES
Devices:
Thermometer,
Nasal aspirator, Pulse Rate and Oxygen Saturation Monitor, Nebulizer, Humidifier,
Hot & Cold packs, Bandage, Band-aid
Breast pumps - all types
NOTE: Consult with doctor on suitability of use
Childhood-Adolescence
ADDITIONAL EXAMPLES
Devices: Toothbrush, Orthopedic brace, Crutch, Menstrual product, Weight scale
Diagnostics: Glucose monitor (some), Pulse oximeter, Flu, Covid-19
Adulthood
ADDITIONAL EXAMPLES
Devices: Reading glasses, Breast pump, Hearing Aids, Self-fitting Hearing Aids, Compression stocking, Otoscope, Defibrillator, Infusion pump
Diagnostics: Sleep apnea App, Cuff Blood pressure monitor, Tests for Cholesterol, Prothrombin (clotting), Ovulation, Pregnancy, Menopause, Urinary tract Infection, Controlled substances (drug test)
Elderly
ADDITIONAL EXAMPLES
Devices: Walker, Cane, Shower aid, Wheelchair, Mobility scooter, Transfer aid, Bed rail, Medication reminder, Medication dispenser
Environmental Protection
Sunglass, Earplug, Mask, Glove, Gown, Head protection
Some are regulated along with other federal agencies like EPA, CDC, OSHA
FDA Does
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Set standards (controls) for effectiveness, safety, usability, manufacturing quality, durability, testing, cybersecurity (for software)
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Requires products to have clear labeling for any person to:
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Self-diagnose their condition
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Self-select that the device is appropriate
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Self-treat and self-manage the condition
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Use and maintain device correctly
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Understand safety, limitations with use
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Review scientific applications for product marketing authorization (some are exempt)
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Monitor post-marketing reports of safety, quality, false promotion and take appropriate action
NOTE: Home Use products can be
Nonprescription (OTC): Have low to moderate risk, low chance of misuse - no doctor involvement
Prescription: Have higher risk - need doctor involvement
Digital Health & Wellness
Digital Health
Help to make better decisions about own health, prevention, early diagnosis and management of health conditions - as Mobile Health Apps, in Wearables with sensors.
FDA reviews software performance, safety, cybersecurity, privacy features.
Several available
Label should clearly say for 'Over-the-Counter' or 'Nonprescription' use
AI Devices &
AR/VR Devices
For making predictions, recommendations, decisions, guide medical procedures, support rehabilitation
FDA has special standards for reviewing effectiveness and safety
These are prescription devices only at this time
AI: Artificial Intelligence, AR: Augmented Reality, VR: Virtual Reality
General Wellness Products
For maintaining or encouraging a healthy lifestyle and are low risk
Do not make diagnosis or treat, prevent, lessen a medical condition, disease
Examples are step counter, sleep environment products, ergonomic products
Not medical devices
No FDA oversight, may not follow FDA standards
General Benefit-Risk
Benefits
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Easy purchase without a prescription
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Can use device correctly (following labeling directions) without doctor help
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Digital technologies provide innovative ways for personal healthcare
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Support early detection, monitoring of medical conditions
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Device reliability supported by FDA standards for usability, efficacy, safety, quality, cybersecurity, postmarket monitoring
Risks
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Incorrect selection
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Incorrect use, maintenance
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Possible side effects
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Home environment affecting device use/performance
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Pets, dust, temperature extremes, poor lighting, mobile phone connectivity
CHECKLIST
For correct selection, use, maintenance
1
Read label on package
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DESCRIPTION: Intended use
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CONTENT: Hardware components, software requirements (if needed), photos (if provided)
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DIRECTIONS: For use, storage, power requirements, internet requirements
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WARNINGS: When not to use, when to see a doctor, possible adverse effects
2
Read label provided inside package
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Keep Instructions for Use with the device
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Details on what is it for and what it is not for
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What is needed to operate like electricity, batteries, running water, telephone, connectivity
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How to store before you use it (especially if it is a diagnostic), expiration dates
3
Use the device or run the test correctly
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How to properly place the hardware for example a blood pressure cuff
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When and how to run a test, including timing instructions
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How to collect and store sample for a test
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Pay attention to special use needs for infants, children
4
Read and understand the results correctly
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Refer to label instructions
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Sometimes may need to repeat testing to be sure
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Pay attention to alarms and error messages
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Be familiar with what the alarms and error messages mean
5
Check your home environment
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Areas that may be problematic for use like stairs, doorways, bathrooms, house wiring
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Keep out of reach from children and pets particularly small devices, batteries
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Don't let children play with dials, settings, on/off switches, tubings
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Turn off your device when not using it
6
Practice proper maintenance, outside home use
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Follow instructions for cleaning, replacing batteries, filters
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Keep food and drinks away
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Safely take from home to school, work, church, vacation spots
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Check if other places are suited for use
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Check weather conditions (heat, wind, rain) that might be damaging
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Dispose according to the manufacturer’s instructions
7
Have a back-up plan
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What to do if device fails
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Keep extra batteries, know how to replace them
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Contact manufacturer
8
Check with your doctor
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If you have concerns about your results
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Don't change medications or dosages based on a home-use test without talking to your doctor
Value of Nonprescription Devices, Diagnostics
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For quick, timely availability, for at-home use
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Designed for effective and safe use at home
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Manage care more independently, improve disease management
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Earlier detection, timely intervention with tests at home - help with discussions with doctor
What to watchout for
False claims by wellness devices, including Apps and diagnostics, that are not FDA-regulated
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Products that claim to diagnose, prevent, treat, or cure diseases or other health conditions, but do not follow FDA standards for effectiveness, safety, quality
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Waste money, can lead to delays in getting proper diagnosis and treatment
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Can also cause serious or even fatal injuries
Privacy concerns with connected devices
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Data not adequately protect
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Sold to other third parties
Improper business practices
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Difficult to cancel recurring subscriptions to software products
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Not receiving promised supplies for maintenance
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Selling defective devices
RESOURCES FOR YOU
FDA Checklist for Home Use Medical Devices
Maintain your medical device safely and effectively at home
FDA Caution on Smartwatches, Smart Rings
Safety information to protect from unreliable diagnosis
FDA Caution on Baby Products with SIDS claim
Against purchasing baby products with claims to prevent or reduce the chance of Sudden Infant Death Syndrome (SIDS)
If you are experiencing a harmful effect
Seek medical Care
REPORT SERIOUS PROBLEMS TO FDA
Online through Safety Reporting Portal →