Is My Product a Medical Device?

TAMU BMEN 253

Where is the definition of a medical device defined in FDA

Section 201(h) of the Food, Drug & Cosmetic Act (FD&C Act)

Definition of a Medical Device

1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them

2. diagnosis, or in the cure, mitigation, treatment, or prevention of disease in man or other animals

3. intended to affect the structure or any function of the body of man or other animals

4. primary purpose not achieved through chemical action and not dependent on metabolization to achieve purpose

5. does not include software functions excluded pursuant to section 520(o).

Examples of Excluded Software

• Administrative support of health care facility;

• Maintaining or encouraging a healthy lifestyle unrelate

• electronic patient records

• Transferring, storing, converting formats, or displaying test or results but not intended to interpret or analyze them.

Know Your Product

• What is the intended use of your product?

• How does your product function?

• What claims do you intend to make?

Defining Your Intended Use is Key!

Clearly state the general purpose or function

• disease or condition of intended use

• intended patient population

Special Considerations: In Vitro Diagnostics (IVDs)

• Reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions.

• Collect, prepare, and examine specimens

  • laboratory, health professional setting, or at home

• Examples: Home Pregnancy Test, Glucose Test Strip

Radiation Emitting Products

Section 531 of the FD&C Act:

• product which when in operation

  • contains or acts as part of an electronic circuit

  • emits electronic product radiation

• Most radiation-emitting products are not medical devices

  Examples: Diagnostic Ultrasound, X-Rays, Medical Lasers

Mobile Medical Applications

(MMAs) in middle

Software as a Medical Device (SaMD)

software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device

• Software that allows a smartphone to view images obtained from a magnetic resonance imaging (MRI) medical device for diagnostic purposes

General Wellness Products

Products must meet the following two factors:

1. Are intended for only general wellness use, as defined in the guidance, and

2. Present a very low risk to users’ safety

Combination Products

therapeutic and diagnostic products that combine drugs, devices, and/or biological products

• Lead center is based on a determination of the “primary mode of action” (PMOA)

Examples: Drug Eluting Stent, Heparin Coated Dialysis Catheter, First-Aid Kit with a Drug

Products Regulated by Other FDA Centers

• Center for Drug Evaluation and Research (CDER)

• Center for Biologics Evaluation and Research (CBER)

• Center for Veterinary Medicine (CVM)

• Center for Tobacco Products (CTP)

Medical Device Definition Questions

1 Is it intended to diagnose, cure, mitigate, treat, or prevent disease in a human?

2 Is it intended to affect the structure or any function of the body?

3 Does it achieve its primary intended purpose by chemical action or by being metabolized?

Additional Questions

Is there an existing product classification?

Is the product regulated as a medical device?

Summary

• Medical devices are defined under Section 201(h) of the FD&C Act

• A clearly defined intended use is key

• Identifying an existing medical device product classification can be helpful

• Consider further assistance if necessary