Important Definitions

National Archives:  Representative Gerald Ford reading (ca 1953)

The following information is abstracted from our reprint, A Brief History of the GMPs:  The Power of Storytelling. This article was originally published in BioPharm Magazine in August 2000, with permission to reprint given by the publisher, Advanstar Communications.

Important Definitions

The following definitions describe the major differences between drugs, biologics, and devices.


The Food, Drug and Cosmetic (FD&C) Act defines drugs as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”  It is the intended use that determines whether something is a drug. Thus, foods and cosmetics may be subject to the drug requirements of the law if therapeutic claims are made for them.  The FD&C Act prohibits adulteration or misbranding of any drug and requires that “new drugs” be reviewed and approved by FDA before they go to market.

Drug applications typically fall into three categories:  a New Drug Application (NDA), a New Animal Drug Application (NADA), or an Abbreviated New Drug Application (ANDA) for generic products.


The Public Health Services (PHS) Act defines a biological product as “any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product…applicable to the prevention, treatment, or cure of diseases or injuries of man….”  Biologics include such vitally important products as polio and measles vaccines, diphtheria and tetanus toxoids, and skin test substances as well as whole blood and blood components for transfusions.  Biological products are subject to all the adulteration, misbranding, and registration provisions of the FD&C Act.  Because most biological products are derived from living organisms, they are by their nature potentially dangerous if improperly prepared or tested.  Under the PHS Act, manufacturers wishing to ship biological products in interstate commerce or for import or export must obtain the appropriate U.S. license(s).

Previous licensing requirements called for both an Establishment and a Product License Application (ELA and PLA) to be filed.   That has recently been streamlined into the single Biologics Licensing Application (BLA). 


Medical devices include several thousand health products, from simple items such as thermometers, tongue depressors, and heating pads to IUDs, heart pacemakers, and kidney dialysis machines.  Under the FD&C Act, a device is defined as “any health-care product that does not achieve its principal intended purposes by chemical action in or on the body or by being metabolized.”  Products that work by chemical or metabolic action are regulated as drugs.  The term “devices” also includes components, parts, or accessories of medical devices, diagnostic aids such as reagents, antibiotic sensitivity disks, and test kits for in vitro (outside the body) diagnosis of diseases and other conditions.

Three classes of medical devices exist:

  • Class I, General Controls (registration of manufacturers, record-keeping and labeling requirements, compliance with CGMPs)
  • Class II, Special Controls (including performance standards, postmarket surveillance, and patient registries)
  • Class III, Premarket Approval (implanted and life-supporting or life-sustaining devices).
Devices “substantially equivalent” to others may be filed using a 510(K) application; all others, and all Class III devices, require filing a premarket approval application (PMA).

Use Information
The information on this page is provided free-of-charge for downloading, photocopying, and using in your classes or department meetings.  The reprinting, transmission, or distribution for sale or use in a for-fee conference or course of this information is expressly prohibited. If you download the material, please ensure that the following copyright statement appears prominently on the bottom of each page downloaded:

Copyright 2010, Immel Resources LLC, Petaluma, CA USA, (707) 778-7222, 
Permission to reprint given by Immel Resources LLC.

This information is not all-inclusive nor is it intended to replace the advice of an experienced quality assurance or regulatory compliance professional.  Every organization manufacturing pharmaceutical, biological, and medical device products must meet at least the minimum applicable current good manufacturing practices (CGMPs).

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