Classification of Products as Drugs 
and Devices & Additional Product 
Classification Issues: 
Guidance for Industry and FDA Staff 
 
 
 
FINAL GUIDANCE 
 
 
 
 
 
 
 
 
 
Additional copies are available from: 
Office of Combination Products  
Food and Drug Administration  
WO32, Hub/Mail Room #5129  
10903 New Hampshire Avenue 
Silver Spring, MD 20993 
(Tel) 301-796-8930 
 (Fax) 301-847-8619 
http://www.fda.gov/CombinationProducts/default.htm. 
 
For questions regarding this document contact the Office of Combination Products at 301-796-
8930 or combination@fda.gov. 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Combination Products 
Office of Special Medical Programs 
Office of the Commissioner 
 
September 2017  Contains Nonbinding Recommendations 
Table of Contents 
I.  INTRODUCTION ............................................................................................................................... 2 
II.  WHAT IS THE PROCESS FOR OBTAINING A FORMAL CLASSIFICATION 
DETERMINATION FOR A PRODUCT? ................................................................................................................ 3 
III.  WHAT DOES FDA CONSIDER IN DETERMINING WHETHER TO CLASSIFY A 
PRODUCT AS A DRUG OR DEVICE? ................................................................................................................... 4 
A.  STATUTORY DEFINITIONS .................................................................................................................. 5 
1.  Drug ............................................................................................................................................. 5 
2.  Device ........................................................................................................................................... 5 
B.  CERTAIN KEY PROVISIONS OF THE DEFINITION OF DEVICE ................................................................. 5 
1.  Similar or related article in the definition of device ................................................................ 6 
2.  Primary intended purposes in the definition of device ............................................................. 6 
3.  Chemical action in the definition of device .............................................................................. 7 
4.  Within or on the body in the definition of device ..................................................................... 7 
5.  Illustrative Examples .................................................................................................................... 8 
C.  HOW IS A PRODUCT CLASSIFIED IF IT MEETS THE DEFINITION FOR DRUG (OR FOR BOTH DRUG AND 
DEVICE) AND ALSO MEETS THE DEFINITION FOR BIOLOGICAL PRODUCT? ......................................... 10 
IV.  ADDITIONAL INFORMATION ..................................................................................................... 11 
FREQUENTLY ASKED QUESTIONS .................................................................................................... 12 
 
 
1 
  Contains Nonbinding Recommendations 
Classification of Products as Drugs and Devices & 
Additional Product Classification Issues: 
1
Guidance for Industry and FDA Staff  
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if the approach satisfies the requirements of the applicable statutes and 
regulations.  To discuss an alternative approach, contact the FDA office responsible for this guidance as 
listed on the title page of this guidance.  
 
 
I.  INTRODUCTION1  
FDA regularly receives questions from medical product sponsors concerning the 
classification of their products.2  We believe that efficient, effective regulation is facilitated by 
providing guidance on issues frequently raised in relation to Requests for Designation (RFDs) 
and other classification activities.  In addition, providing as much clarity and predictability as 
possible with respect to product classifications should enable informed planning for product 
development.  Accordingly, we have prepared this guidance to make the Agencys current 
thinking concerning certain product classification issues more readily and widely available. 
 
While issues have arisen relating to whether a product should be classified as a drug, 
device, biological product, or combination product, most of these issues have related to whether 
a product should be classified as either a drug or a device.3  Accordingly, this guidance focuses 
particularly on cases in which a product4 may be classified as a drug or device.5  This guidance 
also addresses additional issues relating to product classification, including how to obtain 
classification determinations from FDA for medical products. 
 
This guidance is organized into two substantive sections.   
                                                 
1 This guidance has been prepared by the Office of Combination Products in consultation with the Center 
for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Drug 
Evaluation and Research.   
2 Please note that classification as used in this guidance refers to a products designation as a drug, 
device, biological product, or combination product.  This is distinct from the use of the term classification in 
reference to the class (Class I, II, or III) of a device as described in section 513(a) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act). 
3 This guidance addresses the definitions for the terms drug, device, and biological product in section III.  
The term combination product is defined in 21 CFR 3.2(e).  For further information regarding the definition for 
the term combination product and the regulation of combination products, please visit the webpage for the Office of 
Combination Products at www.fda.gov/CombinationProducts/default.htm. 
4 The guidances discussion of the classification of products is also relevant to classification of the 
constituent parts of a combination product.    
5 This guidance focuses on classification of products for human use.  Distinct considerations may apply in 
determining how to classify a product intended for use in animals.   
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  Contains Nonbinding Recommendations 
 
Section II offers guidance on the RFD process for obtaining a formal determination of a 
products classification.   
 
Section III presents general concepts regarding FDAs decision-making process for 
classification determinations and addresses issues that may arise in determining whether 
products should be classified as drugs or devices.6   
 
The Agency recommends that sponsors contact the Office of Combination Products 
(OCP) to confirm the classification of any products they may wish to market if the appropriate 
classification is unclear or in dispute.  Section IV provides contact information for OCP and 
responses to frequently asked questions. 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.   
 
II.  WHAT IS THE PROCESS FOR OBTAINING A FORMAL CLASSIFICATION 
DETERMINATION FOR A PRODUCT? 
If the classification of a product as a drug, device, biological product, or combination 
product is unclear or in dispute, a sponsor can submit an RFD to OCP in accordance with Part 3 
of Title 21 of the Code of Federal Regulations (21 CFR Part 3) to obtain a formal classification 
determination for the product, as provided for under section 563 of the FD&C Act (21 USC 
360bbb-2).  Any RFD determined to be incomplete will be returned to the sponsor with a request 
for the missing information.7  21 CFR 3.8(a).  Once OCP determines the RFD is complete for 
filing, the Agency reviews the RFD.   
 
The sponsor recommends a classification in the RFD, and should explain the basis for the 
recommendation.  While the sponsor should justify why it believes the product meets the 
recommended classification, we generally consider both the information provided in the RFD 
and other information available to the Agency at that time in making our designation.   
 
Generally, OCP will respond to the sponsor in writing within sixty days of the RFD 
filing, identifying the classification of the product as a drug, device, biological product, or 
                                                 
6 This section generally focuses on approaches for determining whether a product should be classified as a 
drug or a device, based on application of the statutory definitions for these terms under sections 201(g) and 201(h) 
of the FD&C Act (21 USC 321(g) and (h)), respectively.  Please note that this document does not focus on the 
classification of products as biological products regulated under section 351(i) of the Public Health Service Act 
(PHS Act) (42 USC 262(i)).  It also does not address under what circumstances certain human cells, tissues, or 
cellular or tissue-based products (HCT/Ps), as defined in 21 CFR Part 1271, are regulated solely under section 361 
of the PHS Act.  For guidance concerning HCT/Ps, please visit 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/.   
7 See 21 CFR 3.7 for content requirements for RFDs. 
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  Contains Nonbinding Recommendations 
combination product.  If the Agency does not provide a written response within sixty days, the 
sponsors recommendation respecting the classification of the product is considered to be the 
final determination.  21 USC 360bbb-2(b) and (c).   
 
RFD determinations pertain only to the product as described in the designation letter, 
including its proposed use(s) or indication(s) for use.  The Agency may modify a determination 
made under section 563 regarding the classification of a product or the component of FDA that 
will regulate the product either with the written consent of the sponsor or for public health 
reasons based on scientific evidence.  21 USC 360bbb-2(b) and (c).8   
 
A new determination may be appropriate if there is a change in, for example, a proposed 
indication for use or in a component of the product, or if the sponsor or Agency becomes aware 
of additional information that reveals that the means by which the product achieves its primary 
intended purposes differ from what was originally described in the RFD.  For example, if a 
sponsor wished to change the indication for a product and that new indication would be achieved 
through a different mechanism than the original indication, a different classification for the new 
indication might be appropriate.   
 
Please contact OCP if you have questions regarding whether to submit an RFD, what 
information to provide, or issues to address in an RFD to ensure its completeness and clarity.9   
 
III.  WHAT DOES FDA CONSIDER IN DETERMINING WHETHER TO CLASSIFY 
A PRODUCT AS A DRUG OR DEVICE? 
FDAs determination of whether to classify a product as a drug or device is based on 
statutory definitions, as set forth in sections 201(g) and 201(h) of the FD&C Act, respectively.  
We apply these definitions to products, relying on the scientific data that are available to FDA at 
the time of the classification determination concerning the product for its proposed 
use(s)/indication(s).10 
   
                                                 
8 The sponsor may request reconsideration of the decision if its classification recommendation is not 
adopted by the Agency.  See 21 CFR 3.8, 10.75.  If the sponsor develops or becomes aware of new information that 
may affect the products classification, the sponsor may also submit a new RFD seeking a new determination.   
9 More detailed information on the RFD process is provided in OCPs guidance How to Write a Request for 
Designation (RFD), available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm126053.htm.  A pre-
RFD process is available if a sponsor wishes to obtain a preliminary, non-binding classification determination or to 
engage in preliminary classification discussions with the Agency before filing a formal RFD.  The RFD and pre-
RFD processes are also available to sponsors to clarify the Center assignment for medical products, though this issue 
is beyond the scope of this guidance.  More information about the pre-RFD process is available at 
https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM534898.pdf.   
10 If a product type has been classified by regulation, FDA would generally classify the product (including 
as a constituent part of a combination product) in accordance with the regulation, if the product (or constituent part) 
falls within the scope of that regulation.  If the Agency concludes that it may be appropriate to propose changing a 
classification established by regulation, FDA would initiate notice and comment rulemaking to do so.11 The device 
definition also includes a second exclusionary clause stating that a device is not dependent upon being metabolized 
for the achievement of its primary intended purposes.  This clause has not been at issue frequently in classification 
determinations.  Accordingly, we do not offer guidance on its construction here.  If sponsors have questions 
regarding the Agencys interpretation of this clause, they may contact OCP. 
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  Contains Nonbinding Recommendations 
Medical product classification determinations often focus substantially on whether a 
product that meets the definition of drug also meets the statutory definition of device.  This 
section presents the drug and device definitions and discusses how the Agency addresses certain 
issues that arise when determining whether a product should be classified as a drug or device.   
 
A.  Statutory Definitions 
1.  Drug 
Section 201(g) of the FD&C Act (21 USC 321(g)) provides that the term "drug" means:  
 
(A) articles recognized in the official United States Pharmacopoeia, official 
Homoeopathic Pharmacopoeia of the United States, or official National 
Formulary, or any supplement to any of them; and (B) articles intended for use in 
the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other 
animals; and (C) articles (other than food) intended to affect the structure or any 
function of the body of man or other animals; and (D) articles intended for use as 
a component of any articles specified in clause (A), (B), or (C). . . . 
 
2.  Device   
Section 201(h) of the FD&C Act (21 USC 321(h)) provides that the term "device" means: 
 
an instrument, apparatus, implement, machine, contrivance, implant, in vitro 
reagent, or other similar or related article, including any component, part, or 
accessory, which is-- 
(1) recognized in the official National Formulary, or the United States 
Pharmacopeia, or any supplement to them, 
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, 
mitigation, treatment, or prevention of disease, in man or other animals, or 
(3) intended to affect the structure or any function of the body of man or other 
animals, and  
 
which does not achieve its primary intended purposes through chemical action 
within or on the body of man or other animals and which is not dependent upon 
being metabolized for the achievement of its primary intended purposes. 
 
B.  Certain key provisions of the definition of device  
Conceptually, all FDA-regulated medical products meet the definition of drug under 
section 201(g) of the FD&C Act, due to the broader scope of the drug definition.  For a medical 
product also to meet the more restrictive device definition under section 201(h) of the FD&C 
Act, it must (i) be an instrument, apparatus, implement, machine, contrivance, implant, in vitro 
reagent, or other similar or related article, and (ii) not achieve its primary intended purposes 
through chemical action within or on the body of man or other animals and (iii) not [be] 
dependent upon being metabolized for the achievement of its primary intended purposes 
(emphasis added).   
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  Contains Nonbinding Recommendations 
 
The sponsor presumably has the most complete information relevant to how its proposed 
product achieves its primary intended purpose(s).  Sponsors seeking a classification 
determination should present all available data and other information potentially relevant to that 
determination (without regard to whether the data or information supports the sponsors 
preferred outcome).  For example, for a sponsor seeking to classify its proposed product as a 
device, those data should demonstrate that its product meets the definition of a device. 
 
At the classification stage, sponsors would not be expected to have gathered sufficient 
data to demonstrate that their proposed product meets the applicable marketing authorization 
standard (e.g., data demonstrating effectiveness).  Therefore, the focus of FDAs classification 
analysis is on how the product would be expected to achieve its primary intended purposes, 
assuming it is capable of achieving its primary intended purposes at all.  FDA will use its best 
scientific judgment to evaluate all available information relevant to the classification 
determination, including information submitted by the sponsor or available in the literature.   
 
The following discussion presents the Agencys current thinking on certain issues that 
arise with respect to the statutory definition of device. 
 
1.   Similar or related article in the definition of device 
The first clause of the device definition provides that the term means an instrument, 
apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related 
article . . . (emphasis added).  The issue of whether a product may be considered a similar or 
related article under this clause can arise, for example, with regard to products in liquid, semi-
liquid, gel, gas, or powder form.  In some cases, such products are appropriately considered 
similar or related articles, and may be classified as devices, so long as they also satisfy the 
remainder of the device definition under section 201(h) of the FD&C Act, including the chemical 
action exclusion discussed in section III.B.3 below.  This could be the case, for example, for gels 
or powders put on the skin as a barrier, gases used as space fillers, or liquids used to clean either 
surgical instruments or contact lenses. 
 
2.   Primary intended purposes in the definition of device 
Most often, in determining whether a product meets the device definition, questions arise 
concerning the exclusionary clause of the definition, which provides that a device is a product 
which does not achieve its primary intended purposes through chemical action within or on the 
body of man or other animals . . . .11  A product that has chemical action could be a device if it 
does not achieve its primary intended purposes through that chemical action.       
 
                                                 
11 The device definition also includes a second exclusionary clause stating that a device is not dependent 
upon being metabolized for the achievement of its primary intended purposes.  This clause has not been at issue 
frequently in classification determinations.  Accordingly, we do not offer guidance on its construction here.  If 
sponsors have questions regarding the Agencys interpretation of this clause, they may contact OCP. 
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  Contains Nonbinding Recommendations 
For example, if the primary intended purpose of a hip joint replacement implant is to 
restore movement, and the implant also elicits a foreign body response through chemical action, 
that response would not be considered a primary intended purpose of the implant.  Accordingly, 
such an implant could be classified as a device despite the chemical action, because such action 
does not achieve the products primary intended purpose.  Similarly, if the primary intended 
purpose of an absorbable suture is to rejoin tissue, and the suture is also designed to be resorbed 
by the body through a combination of chemical action and metabolic activities, such resorption 
would not be considered a primary intended purpose of the product.  Accordingly, such an 
absorbable suture could be classified as a device despite the chemical action and metabolic 
activity, because such action or activity does not achieve the products primary intended purpose.   
 
3.  Chemical action in the definition of device 
FDA frequently receives questions from product sponsors concerning the Agencys 
interpretation of the term chemical action.  This term must be read in the context of the 
statutory definition of device as a whole.  The determination of whether a product meets the 
device definition does not depend solely on whether the product exhibits chemical action.  In 
particular, as explained in section III.B.2 and 4, a product that exhibits chemical action will still 
meet the device definition if the product does not achieve its primary intended purposes 
through that chemical action within or on the body, and otherwise satisfies the device 
definition. 
 
Under the Agencys interpretation of the device definition, a product exhibits chemical 
action if it interacts at the molecular level with bodily components (e.g., cells or tissues) to 
mediate (including promoting or inhibiting) a bodily response, or with foreign entities (e.g., 
organisms or chemicals) so as to alter that entitys interaction with the body.12  We note that this 
type of interaction is consistent with the term pharmacological action as that term is generally 
understood in the medical field.  Accordingly, we have used pharmacological action as a short-
hand throughout the rest of this guidance for ease of explication and recognition.  The examples 
presented in section III.B.5 offer illustration of FDAs interpretation of chemical action.    
 
4.  Within or on the body in the definition of device  
Because a device does not achieve its primary intended purposes through chemical 
action within or on the body of man or other animals (emphasis added), a product can be a 
device even if it achieves its primary intended purposes through chemical action, so long as the 
chemical action does not occur within or on the body (and the product meets the other 
elements of the definition of device under section 201(h)).   
 
Whether chemical action is occurring within or on the body is generally a 
straightforward matter.  If the chemical action is occurring inside the body or on the surface of 
the body, it is within or on the body.  For example, the chemical action of an orally ingested pill 
                                                 
12 For purposes of this interpretation, an interaction at the molecular level occurs through either chemical 
reaction (i.e., formation or breaking of covalent or ionic bonds), intermolecular forces (e.g., electrostatic 
interactions), or both.  The mere exchange of non-chemical energy (e.g., electromagnetic or thermal energy) 
between a product and the body would not constitute chemical action. 
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  Contains Nonbinding Recommendations 
or tablet of a decongestant would be within the body, and the chemical action of a spray or 
cream for treatment of dermatitis when applied to the skin would be on the body.  Similarly, it 
is generally a straightforward matter to determine that chemical action is not occurring within or 
on the body.  For example, the chemical action of an antimicrobial agent used to clean a surgical 
instrument before that instrument is used is not occurring within or on the body. 
 
However, the Agency has on occasion considered some situations in which it may be less 
clear whether chemical action is occurring within or on the body.  For example, we have 
determined that chemical action occurring solely within an extracorporeal device, specifically a 
kidney hemodialysis machine, is not occurring within or on the body.  Similarly, we have 
determined that the chemical action of a transport solution to preserve a donor organ for 
transplantation while in an organ transport container is not occurring within or on the body. 
 
5.  Illustrative Examples  
The following examples further illustrate the application of some of the key provisions of 
the device definition discussed above.  Table 1 contains some examples of medical products that 
achieve their primary intended purposes through chemical action within or on the body.  Table 2 
contains some examples of medical products that do not achieve their primary intended purposes 
through chemical action within or on the body.  
 
 
Table 1:   Examples of Medical Products that Achieve Their Primary Intended Purposes 
through Chemical Action within or on the Body 
 
Product  Description  
Aspirin  Aspirin is used for pain relief.  Acetylsalicyclic acid (aspirin) contains an acetyl 
group that has the ability to covalently bind to a serine residue of a cyclooxygenase 
enzyme (COX-1 or COX-2). This is considered pharmacological action because it 
inactivates the enzyme and thereby inhibits the synthesis of prostaglandin and 
thromboxanes, which suppresses the bodys inflammatory response for pain relief.  
 
Beta Blockers  Beta blockers are used to reduce blood pressure.  Cells contain beta receptors that 
can be stimulated by neurotransmitters such as adrenaline/epinephrine.  Beta 
blockers, like propranolol, bind beta receptors (b1 and b2) and exhibit 
pharmacological action by inhibiting the activation of the signaling cascade. This 
blockage causes cardiac cells to reduce the strength of cardiac contractions and 
heart rate. 
 
Magnesium Sulfate  Magnesium sulfate is used as replacement therapy for magnesium deficiency. It 
acts as a catalyst in enzymatic reactions (a molecular-level interaction). While the 
chemical or atomic structure of magnesium sulfate is not altered, its participation in 
enzymatic reactions is considered a pharmacological action because it impacts 
various cellular and molecular processes.   
 
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  Contains Nonbinding Recommendations 
Polymyxin B  Polymyxin B sulfate is an antibiotic that is used to treat bacterial infection. It is 
Sulfate  composed of a cationic protein surfactant that has fatty acid functional groups. 
Polymyxin B sulfate acts through intermolecular forces, by binding to components 
of the bacterial membrane (i.e., the membrane of the foreign entity) and by 
association/fusion of the fatty acid portion of the molecule with the lipid bilayer via 
hydrophobic interactions.  This binding is a pharmacological action because it 
disrupts the integrity of the bacterial membrane, which causes organism death, 
thereby treating the bacterial infection. 
 
Hydroxocobalamin  Hydroxocobalamin is used as an antidote to cyanide poisoning. The cobalt moiety 
of hydroxocobalamin exhibits pharmacological action because it chemically reacts 
with cyanide, a toxic chemical agent, to form cyanocobalamin, a non-toxic 
compound, and the ability of hydroxocobalamin to interact with cyanide facilitates 
the removal of the toxic agent in order to inhibit the toxic effects of cyanide on the 
body. 
 
Table 2:    Examples of Medical Products That Do Not Achieve Their Primary Intended 
Purposes through Chemical Action within or on the Body 
 
Product   Description 
Abdominal Adhesion  Inert, biodegradable synthetic polymers can be used to reduce post-operative 
Barrier  adhesions with tissues and organs within the abdominal cavity. An implanted 
physical barrier sheet composed of such polymers would act to reduce 
adhesion through physical separation of tissue and not through 
pharmacological action on the surrounding tissue. 
 
Polymethylmethacrylate  PMMA is an acrylate polymer that is used as a temporary bone spacer. PMMA 
(PMMA)  is built from methyl methacrylate monomer units, which undergo free radical 
polymerization in the presence of an initiator compound. The molecules that 
are part of the polymerization process interact with each other to create a solid 
mass to fill a bone void physically. The process does not require an interaction 
between the PMMA and the bone at the molecular level and, therefore is not 
considered chemical action within or on the body. 
 
Topical Surgical  Cyanoacrylate is an acrylic resin that is used to approximate skin tissue as an 
Adhesive  adjunct to a wound closure product. The resin undergoes anionic 
polymerization in the presence of water. The chemical reaction that occurs 
between the resin and ions in the water allows it to form into long polymer 
chains. This type of adhesive can bond to a cut/incision, creating a physically-
intact film to aid in keeping skin edges together.  While the product binds to 
tissue, it does not exhibit pharmacological action because that binding does not 
mediate a bodily response. 
 
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Gold Nanoparticles  Nanoparticles composed of gold can be used to treat cancer. When gold 
nanoparticles are injected into a tumor site and exposed to electromagnetic 
energy, they absorb the electromagnetic energy and convert it to thermal 
energy, and this heat is transferred to the surrounding cells or tissue.  The heat 
transfer, as opposed to a binding interaction with the nanoparticle, causes the 
cancer cells to die. Therefore, this effect is not achieved through chemical 
action. 
 
Cryosurgery for Wart  Cryogen (liquid gas), such as nitrogen or dimethyl ether, is used to treat 
Removal  common and plantar warts. The liquid gas is extremely cold and freezes the 
wart, resulting in damage to the topmost layer of cells.  A physiological effect 
(i.e., cell death) results from heat transfer, not from a binding interaction with 
the gas.  Therefore, the freezing is not considered chemical action. 
 
Dental Amalgam  A resin that fills a cavity in a tooth as part of the treatment of dental caries may 
bind to the tooth via covalent bonding, or rely in part on intermolecular forces 
to change from liquid or paste to solid form.  However, this binding and/or 
state change does not mediate a bodily response, but rather produces a solid 
mass, to fill the cavity. Therefore, it would not be considered chemical action. 
 
Respirator Mask with  An antimicrobial product impregnated into a filter on a respirator mask to kill 
Antimicrobial Filter  microbes that the user might otherwise inhale would exhibit pharmacological 
action.  However, while the mask is in contact with the users face, the filter is 
not.  So, the chemical action occurring on the filter is not occurring within or 
on the body. 
 
C.  How is a product classified if it meets the definition for drug (or for both 
drug and device) and also meets the definition for biological product? 
As explained in section III.B, products that meet the device definition in 201(h) of the 
FD&C Act also meet the drug definition in 201(g) of the FD&C Act.  In addition, products that 
meet the drug definition, or both the drug and device definitions, may also meet the definition of 
biological product under section 351(i) of the PHS Act (42 USC 262(i)).   
 
Section 351(i) provides that: 
 
The term biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, 
blood, blood component or derivative, allergenic product, protein (except any chemically 
synthesized polypeptide),13 or analogous product, or arsphenamine or derivative of 
arsphenamine (or any other trivalent organic arsenic compound), applicable to the 
prevention, treatment, or cure of a disease or condition of human beings. 
  
                                                 
13 For guidance on FDAs interpretation of the category protein (except any chemically synthesized 
polypeptide) see Biosimilars:  Questions and Answers Regarding Implementation of the Biologics Price 
Competition and Innovation Act of 2009, at Q.II.1 (April 2015), available at 
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM444661.pdf.  
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Products that meet the drug definition and that also meet the definition of biological 
product are classified as biological products, and are generally subject to licensure under the 
PHS Act.14  Products that meet the definitions for drug, device, and biological product may also 
be classified as biological products.  If you have questions regarding whether a product meets the 
definition of biological product or how this might affect its classification, please contact OCP.  
 
IV.   ADDITIONAL INFORMATION 
For further information on the classification of products as devices, drugs, biological 
products, or combination products, please refer to the Frequently Asked Questions on the next 
page, OCPs webpage at https://www.fda.gov/CombinationProducts/default.htm or contact OCP 
at:  
 
Office of Combination Product 
Food and Drug Administration 
WO32, Hub/Mail Room #5129 
10903 New Hampshire Avenue 
Silver Spring, MD 20993 
 
(Tel) 301-796-8930 
(Fax) 301301-847-8619 
combination@fda.gov 
                                                 
14 Certain biological products have been historically approved under the FD&C Act and may continue to be 
subject to approval under the FD&C Act until March 23, 2020.  See Section 7002(e) of the Biological Price 
Competition and Innovation Act of 2009; see also FDA, Implementation of the Deemed to be a License Provision 
of the Biologics Price Competition and Innovation Act of 2009, available at 
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm490264.pdf. 
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FREQUENTLY ASKED QUESTIONS 
 
1. Can a product be classified as a device if it exhibits chemical action? 
 
Yes, if the product does not achieve its primary intended purposes through chemical 
action within or on the body and otherwise meets the definition of a device.  However, 
products that meet the device definition may be regulated as drugs or biological products 
in some cases.  See question 2. 
 
2.  If a product meets the definition for drug at 21 USC 321(g) and for device at 21 USC 
321(h), how is it classified? 
 
Generally, the product would be classified as a device, unless it falls within a special 
category (for example, apparatuses used in the preparation of compounded positron 
emission tomography drugs are classified as drugs, see 21 USC 321(ii)). 
 
3. Can the proposed use or indication of a product affect its classification? 
 
Yes.  Two products with exactly the same composition can be classified differently based 
on their primary intended purposes.  For example, if a vaginal product is intended solely 
to facilitate ease and comfort during sexual intercourse and it achieves this through 
lubrication that decreases friction (via mechanical/physical action) and not through 
chemical action, it is classified as a device.  However, the same product can be classified 
as a drug if it is intended, for instance, to alter pH, control odor, or prevent infection, and 
does so through chemical action as discussed in III.B.3 above. 
 
4. What should you do if, after reviewing this guidance, you are unsure of how your product 
is classified? 
 
You should contact the Office of Combination Products (Combination@FDA.GOV) for 
feedback.  OCP will provide you feedback, including on whether a pre-RFD or an RFD 
may be appropriate and what information you should provide. 
 
5. Where can you find additional information about product classification? 
 
Additional information on classification is posted on OCPs webpage 
at:(https://www.fda.gov/CombinationProducts/AboutCombinationProducts/ucm101496.htm) 
 
For additional information on how to submit an RFD, see How to Write a Request for 
Designation (RFD) 
(http://www.fda.gov/RegulatoryInformation/Guidances/ucm126053.htm). 
 
More information about the pre-RFD process is available at 
https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM534898.pdf .   
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