Penn Medicine Clinical Research

Step 1: Determining if you’re using an FDA-regulated Drug or Medical Device

Step 1: Determining if you’re using an FDA-regulated Drug or Medical Device

The FDA regulates a wide range of products, including foods, drugs, vaccines and other biological products, medical devices, radiation-emitting products, cosmetics, dietary supplements, and tobacco products. The regulations are defined in the Code of Federal Regulations (CFR), Title 21 Food and Drugs. 

The first step is determining the product’s category and the associated requirements. If you have developed the product, please first review Product Development.  For further guidance or questions that are not addressed on this page, please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu.

 

What is a Drug?

 

A drug is a substance that is:

  • Recognized by an official pharmacopoeia or formulary
  • Intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
  • Intended to affect structure or function of the body (* other than food)
  • Intended for use as a component of a medicine but not a device or a component of a device

 

Biological products are included within this definition and generally follow the same laws and regulations, with some differences regarding their manufacturing processes.

References:

 

What is a Medical Device? *

 

A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, which is:

  • Recognized in the official pharmacopoeia or formulary
  • Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or
  • Intended to affect the structure or any function of the body, and which does not achieve its primary purpose through chemical action within or on the body, and which is not dependent upon being metabolized for the achievement of its primary purpose.

 

* Certain software and mobile medical apps, including those using artificial intelligence and/or machine learning algorithms, can also fall under the medical device regulations. The FDA’s Digital Health Policy Navigator may be a helpful tool.

 

References: