Contains Nonbinding Recommendations
Medical Device Classification Product 
Codes
Guidance for Industry and 
Food and Drug Administration Staff 
Document issued on April 11, 2013. 
The draft of this document was issued on January 3, 2012.
For questions about this document regarding CDRH or CBER-regulated devices, contact the 
CDRH 510(k) Program at 510k_program@fda.hhs.gov or (301) 796-5640.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research   Contains Nonbinding Recommendations 
 
Preface 
 
Public Comment 
 
You may submit written comments and suggestions at any time for Agency consideration to the 
Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
(HFA-305), Rockville, MD, 20852.  Submit electronic comments to http://www.regulations.gov.  
Identify all comments with the docket number listed in the notice of availability that publishes in 
the Federal Register.  Comments may not be acted upon by the Agency until the document is next 
revised or updated. 
 
Additional Copies 
 
Additional copies are available from the Internet. You may also send an e-mail request to 
dsmica@fda.hhs.gov  to receive an electronic copy of the guidance or send a fax request to 
301-827-8149 to receive a hard copy. Please use the document number (1774) to identify the 
guidance you are requesting. 
 
Additional copies of this guidance document are also available from the Center for Biologics 
Evaluation and Research (CBER) by written request, Office of Communication, Outreach and 
Development (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, by 
telephone, 1-800-835-4709 or 301-827-1800, by email,  ocod@fda.hhs.gov, or from the Internet 
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/de 
fault.htm. 
    Contains Nonbinding Recommendations 
 
Medical Device Classification 
Product Codes 
 
Guidance for Industry and Food and 
 Drug Administration Staff 
 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on 
this topic.  It does not create or confer any rights for or on any person and does not operate to 
bind FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the appropriate number listed on the title page of this 
guidance.  
 
Introduction 
 
Since the passage of the May 28, 1976 Medical Device Amendments to the Food, Drug and 
Cosmetic Act (FD&C Act), the Classification Regulation Panels (21 CFR Parts 862-892) have 
been the basis for the Center for Devices and Radiological Healths (CDRHs) Classification 
Product Code structure and organization. In order to respond to the evolution of device 
technology, classification product codes were created to assist in accurate identification and 
tracking of current medical devices and to allow for tracking of and easy reference to predicate 
device types. Classification product codes are used by FDA to obtain quality and reliable data, 
and perform analyses that are often reported to Congress, the Government Accountability Office 
(GAO), the general public, the media, and industry. Classification product codes are also used 
throughout the total product life cycle (TPLC) as they connect all medical device databases. 
 
This document describes how device product codes are used in a variety of FDA program areas 
to regulate and track medical devices regulated by the Center for Devices and Radiological 
Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).  This document 
is limited to medical devices as defined in section 201(h) of the Federal Food Drug & Cosmetic 
(FD&C) Act and does not discuss classification product codes used to regulate non-medical 
electronic radiation emitting products. 
 
The scope of this document includes devices described in the existing classifications under 
21 CFR Parts 862-892. It also describes how the product code builder developed by FDAs 
Office of Regulatory Affairs is used for devices that are licensed under the Public Health Service 
Act (PHS Act), and currently do not have product codes generated under classification regulation 
    Contains Nonbinding Recommendations 
 
panels. It also covers unclassified devices and devices not yet classified.1 
 
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. 
 
Definition
 
 
Classification product codes are a method of internally classifying and tracking medical 
devices. CDRH and a subset of CBER regulated medical device product codes consist of a 3 
letter combination which associates a devices type with a product classification designated 
for the application. Classification product codes and information associated with these 
devices, such as names and attributes, are assigned by CDRH to support their regulation. 
 
Use of Classification Product Codes in Premarket Review
 
 
1.  General Uses of Classification Product Codes for Premarket 
Submissions 
 
A.  Classification product codes help to delineate technology and indication subgroups 
within a regulation. They can also serve to categorize unclassified or Class III 
(PMA) devices. Some of these subgroups may require different levels of evidence to 
support marketing clearance or approval, or specific warnings in the labeling. 
Classification product codes are also useful to identify devices for subsequent 
changes such as reclassification. If a device is reclassified (e.g., from Class III to 
Class II) the classification product code may stay the same or a new classification 
product code may be created. 
 
B.  Classification product codes are used for internal tracking purposes, such as adverse 
event monitoring or compliance actions. Product codes may be created and assigned 
for these purposes. 
 
C.  Classification product codes are assigned and maintained by the Agency. The 
submitter of the premarket submission selects a product code based on the identified 
predicate device(s).  The proposed product code is reviewed by FDA staff for 
accuracy. If the proposed product code is incorrect, or a more appropriate product 
code should be used, the reviewer will change the product code and notify the 
                                                           
1 An unclassified device is a pre-amendments device for which a classification regulation has not been promulgated.  
Unclassified devices require submission of a 510(k) premarket notification to CDRH.  A not-classified device is a 
post-amendments device for which the Agency has not yet reviewed a marketing application or for which the 
Agency has not made a final decision on such a marketing application.  A pre-amendments device is a device that 
was on the market prior to the enactment of the Medical Device Amendments to the FD&C Act on May 28, 1976. 
    Contains Nonbinding Recommendations 
 
applicant. In the case of adverse event reporting, when an incorrect product code is 
used or a new tracking product code is created, the Agency will assign the most 
accurate product code to the adverse event report. 
 
D.  Proposed classification product codes cited in premarket submissions are used in 
the initial assignment to the appropriate review branch/division.  They are also used 
to determine the review panel for the device. 
 
E.  As new classification product codes are created, a device may be re-assigned into a 
new product code. If this occurs, FDA will send a corrected substantially equivalent 
or approval letter to the manufacturer of the marketed device to notify them of the 
new classification product code. 
 
F.  Guidance documents often define their scope by referencing the classification 
product codes to which they apply. 
 
2.  Premarket Notification [510(k)] Devices 
 
A.  Classification  Product codes are assigned within established classification 
regulations as described in 21 CFR Part 860. They are also assigned to unclassified 
devices and not-classified devices. An unclassified device is a pre-amendments 
device for which a classification regulation has not been promulgated. Until the 
unclassified device type has been formally classified and a regulation established, 
marketing of new devices within this type will require submission of a 510(k) 
premarket notification to CDRH or CBER.  Once classified, these devices may 
require submission of a PMA, a 510(k), or be exempt from any premarket 
submission.  A not-classified device is a post-amendments device for which the 
Agency has not yet reviewed a marketing application or for which the Agency has 
not made a final decision on such a marketing application. 
 
B.  Predicate Devices To demonstrate substantial equivalence and therefore obtain 
clearance of a 510(k) submission, a comparison to a predicate device is provided.  
Selecting a predicate device with the same classification product code as the 
proposed device is usually most appropriate.   
 
C.  Assignment  The reviewer will assign a classification product code based on the 
regulation (if relevant) or the device intended use, indications for use or technology. 
The most common method of assignment is to use an existing product code from the 
product code database. A device will be assigned an existing classification product 
code when it has the same intended use, indications for use, and relies on 
technology that does not raise new safety and effectiveness questions. However, if 
the proposed device differs significantly from the predicate device with respect to 
technology, intended use or indications for use or is found not substantially 
equivalent (NSE), a new product code should be assigned. The 510(k) summary will 
include all classification product codes considered relevant.  The 510(k) clearance 
letter will specify one primary product code for the device and may include 
    Contains Nonbinding Recommendations 
 
subsequent product codes that address additional features or functions of the device. 
The primary classification product code should correspond with the regulation and 
class applicable to the device and should be used in all postmarket correspondence 
as needed. The accurate use of this product code in all actions including premarket 
submissions, adverse event reporting and compliance actions is important to ensure 
accurate communication with the Agency and to avoid potential negative impacts 
such as delays in delivery or shipment.  Multiple subsequent product codes can be 
used even if they fall under a different regulation and class. If multiple product 
codes are assigned to a device, the product code that corresponds with the highest 
regulatory class or, if the regulatory class is the same, the product code 
corresponding to the most relevant technology will be used as the primary product 
code. 
 
D.  Evolution  As technology changes and 510(k) review practice evolves, some 
classification product codes may become obsolete. In some cases, product code 
definitions may be updated to accommodate new technology.  Obsolete product 
codes will still be maintained in the public database for tracking purposes. 
Predicates with obsolete product codes will remain under the same regulation 
and may still be used as valid predicates. A corrected clearance letter should be 
issued when a device with an obsolete product code is assigned a new product 
code.  New classification product codes should be created for a 510(k) when a 
device has a new intended use or when a device incorporates technology that 
raises new questions of safety and effectiveness. In the case where a device is 
found not substantially equivalent (NSE) to a predicate device; the classification 
product code describing the device will be placed in the product code database 
for future reference. Additionally, new product codes may be created for 
tracking purposes for a specific technology or device area. Please see the FAQ 
section of the guidance for instruction on where to seek clarification on an 
assigned product code. 
 
E.  Other  Classification Product codes can be used to help classify other premarket 
submission variations. 
 
i.  Third party eligible 510(k) submissions  The classification database can be 
searched by product code to determine which devices may be eligible for 
third party review. For more information on the classification database, 
please see the Resources section of this guidance document. 
 
ii.  Evaluation of Automatic Class III Designation (De Novo) (513(f)) requests) 
 When a De Novo petition is granted and the device is reclassified, the 
product code assigned when the 510(k) was submitted and determined to be 
NSE will be used.2 Note that Section 607 of the Food and Drug 
Administration Safety and Innovation Act (FDASIA) amended Section 
                                                           
2 See Guidance for Evaluation of Automatic Class III Designation: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080195.htm 
    Contains Nonbinding Recommendations 
 
513(f)(2) of the FD&C Act to allow submission of a De Novo petition 
without submission of a 510(k) and subsequent NSE if there is no legally 
marketed device upon which to base an SE determination.  In such cases, a 
new product code will be assigned at the time that the De Novo petition is 
granted. 
 
iii.  Kits  Product codes have been assigned to established convenience kits that 
are outlined in FDAs Convenience Kits Interim Regulatory Guidance 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Guidan
ceDocuments/ucm080216.htm). The list of established convenience kits can 
be found in the guidance.  
 
3.  Premarket Approval (PMA) Devices and Humanitarian Device 
Exemption (HDE) Devices 
 
A.  The use of product codes for PMA and HDE devices is similar to their use for 
510(k) devices.  A product code is assigned to the device upon approval and is 
included in the subject of the approval letter of a PMA or HDE. 
 
B.  Class III devices are not always classified under a specific regulation, but may have 
a product code assigned. When a regulation for the device type exists, Class III 
devices are assigned under a specific regulation, like Class I and II devices. When 
Class III devices are reclassified to Class II devices, a regulation is created and the 
product code may remain the same or a new product code may be created. 
 
C.  Modifications to an existing Class III device that result in the submission of a PMA 
supplement, such as a change in indications for use, which would be submitted 
through a panel track PMA supplement, may require creation and assignment of a 
new product code for the modified device. 
 
D.  The appropriate product code should be cited in submissions of annual reports. 
 
E.  For HDE submissions, the eligibility for humanitarian exemption is not based on the 
product code of the proposed device. The proposed device, along with the 
indications for use, must be designated as a Humanitarian Use Device by the Office 
of Orphan Products before an HDE can be submitted to CDRH or CBER.3 
 
4.  Investigational Device Exemption (IDE) 
 
A.  A classification product code may be assigned to a device that is the subject of an 
IDE submission and included in the approval letter for an IDE if the device falls in 
a known device area with established technology or will be tracked internally for a 
                                                           
3 For additional information regarding HUD designation, refer to information on the FDA website: 
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/DesignatingHumanitarianUse 
DevicesHUDS/default.htm. 
    Contains Nonbinding Recommendations 
 
specific technology, patient population or device area. 
 
B.  The classification product code assigned to a device that is the subject of an IDE 
application is primarily used for internal tracking purposes and may differ from 
that of the final PMA approval or 510(k) clearance.  In many instances, a product 
code will not be assigned to an IDE submission. 
 
C.  For devices where an established classification product code is known, the 
proposed product code should be specified in the submission. For novel devices, a 
new classification product code will generally be assigned by FDA at the time of 
PMA approval/510(k) clearance. 
 
5.  Request for Classification (513(g)) Applications 
 
Section 513(g) of the FD&C Act (21 U.S.C. 360c(g)) provides a means to obtain the 
Agency's views about the classification and the regulatory requirements that may be 
applicable to a particular device.  FDAs response to a 513(g) request will include, in 
part, the Agency's assessment, based on the information submitted in the request, as to 
the generic type of device (e.g., classification regulation) that the requester's device 
appears to be within (if any); the class of devices within that generic type; and whether a 
PMA, 510(k), or neither is required in order to market devices of the particular class 
within that generic type.  However, a classification product code is not generally 
specified in a 513(g) classification for devices that will require a premarket submission. 
The recommendation in response to the 513(g) submission only lists proposed devices 
within a given regulation.  Devices that are Class I exempt or Class II exempt may 
receive a classification product code as part of this recommendation. 
 
Use of Classification Product Codes in Post Market 
Review 
 
1.  Adverse Events 
 
Classification product codes are a key element in the reporting of adverse events and 
product problems in medical device reports (MDRs). Though not clearly requested in the 
3500A mandatory reporting form (MedWatch Form), it is common practice for 
the reporter to indicate the product code along with the common name of the device in 
section D2 of the 3500A form. The addition of the product code by mandatory reporters 
supports 21 CFR 803.52(c)(2) by describing the type of product. The classification 
product code used by reporters should be the primary product code associated with the 
device for which the report is being made. To improve the quality of MDRs, we 
recommend that reporters include the premarket submission number (if applicable) in 
section G5 of the 3500A form to further link the device to its original classification. 
 
In cases where the classification product code is not known by the reporter and an MDR 
is submitted without one, CDRH assigns the appropriate product code to the MDR based 
    Contains Nonbinding Recommendations 
 
on the brand name (section D1), common device name (section D2), or premarket 
submission number (section D5). However, it is preferred that the reporter of the MDR 
provide the product code with which CDRH classified the device (in the case of Class II 
and III devices). 
 
2.  Import/Export 
 
A.  Office of Regulatory Affairs (ORA) Product Code Builder 
 
In order to ensure that a medical device is in compliance with FDA regulatory 
requirements, importers/brokers/filers are required to submit certain import 
information. One data element that is required to be provided is the product code. If 
the product code is unknown, importers/brokers/filers can use the Office of 
Regulatory Affairs (ORA) Product Code Builder 
(http://www.fda.gov/ForIndustry/ImportProgram/ProductCodeBuilderforFoods/defa
ult.htm) to formulate a product code for the product they are importing. In addition, 
the CDRH Product Classification Database 
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm) can be 
used to look up a device's definition and regulatory requirements, neither of which is 
provided in the ORA Product Code Builder.  As new product codes are created by 
CDRH and old ones modified, ORAs Division of Compliance Systems (DCS) is 
notified, and the Product Code Builder is updated. The product code used for the 
FDA import admissibility review process is formatted differently than the 
classification product code used by CDRH. There is no definitive meaning for the 
three digit classification product codes in CDRHs Product Classification Database. 
However, ORAs Product Code Builder uses a seven digit product code, rather than 
the three letter combination found in the product code database. The seven digit 
product codes encompass devices, foods, drugs, biologics, and cosmetics and each 
digit signifies a particular description. For example, FRN is the product code 
assigned to Pump, Infusion in CDRHs Product Classification Database. The same 
product code translates to 80F--RN in ORAs Product Code Builder.  The two 
numbers at the beginning of the seven-digit product code represent the medical 
specialty panel classified for the device. 
 
B.  Import Entry Process 
 
The classification product code helps the FDA import entry reviewer determine 
what information he/she should verify to ensure the medical device meets all FDA 
regulatory requirements (e.g., registration, listing, clearance/approval numbers). 
 
Classification product codes are also used by FDA to designate products for Import 
Alerts. Import Alerts identify problem commodities, shippers and importers, and 
provide guidance for import coverage. 
 
3.  Recalls 
 
    Contains Nonbinding Recommendations 
 
Classification product codes are an important aspect in reporting recalls, corrections and 
removals. They are used to ensure correct device identification to determine which 
group of the FDA will be responsible for review and classification of the recall, 
correction or removal. Though not clearly required in 21 CFR 806.10, the addition of the 
product code by device manufacturers and importers supports the requirement in 21 
CFR 806.10(c)(4) to provide the devices marketing status, since the product code is 
assigned during pre-market review or approval (510(k), PMA, HDE or EUA 
(Emergency Use Authorization)) and indicates the regulatory classification of the 
device. The device manufacturers and importers should provide the primary product 
code associated with the recalled device, unless the secondary product code is more 
specific. In cases where the product code is not known by the device manufacturer or 
importer, the product code assigned to the device during device listing (Establishment 
Registration and Device Listing) should be used. 
 
4.  Establishment Registration and Device Listing 
 
A.  Determining How FDA Will Classify Your Device 
 
If your product is considered a medical device, you must determine how your 
device is classified by FDA for the purposes of registration and listing.4  Step- by-
step instructions on determining how FDA will classify your device can be found on 
the FDA website.5   Here you will identify the correct device name, regulation 
number, and classification product code for your device. You will use this 
information to list your device in the FDA Unified Registration and Listing System 
(FURLS)/Device Registration and Listing Module (DRLM). If you need assistance 
with determining if your product is a device or the appropriate classification for the 
device, please contact the Division of Small Manufacturers, International, and 
Consumer Assistance (DSMICA) by email at dsmica@fda.hhs.gov  to receive 
assistance. 
 
B.  Listing Your Device 
 
Instructions for listing your device are posted on our website6 under the Initial 
Registration heading. 
 
i.  Exempt Devices 
 
Devices that are not subject to premarket notification (510(k)), premarket 
approval (PMA) or HDE requirements are considered exempt devices. You 
will need to determine the classification product code for your exempt device 
                                                           
4 See 21 CFR Part 807. 
5 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm 
6 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListi
ng/ucm053185.htm 
 
    Contains Nonbinding Recommendations 
 
before you can list the device in FURLS/DRLM. You can identify the 
product code by searching the Product Classification database 
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
).  Once you know the classification product code, you can list the device. 
 
ii.  Non-Exempt Devices 
 
Devices that are subject to premarket notification or premarket approval 
requirements [510(k), PMA] are considered non-exempt devices. If your 
device requires premarket notification clearance or approval 
(510(k) or PMA), please remember the following: 
 
  You cannot list the device until the 510(k) or PMA has been cleared or 
approved. 
 
  You need your premarket submission number to list your device in 
FURLS/DRLM. 
 
  You should list your device with the Premarket Submission Number 
(510(k), PMA). The classification product code that was assigned on 
your clearance/approval letter will appear on your listing. 
 
  If you believe the classification product code in the CDRH Corporate 
database is not correct, then you will need to contact the Program 
Operations Staff (POS) in ODE for assistance with correcting this 
information. Contact information is listed in the Resource Section of 
this guidance document. 
 
iii. Devices Licensed as Biological Products under the PHS Act 
 
Manufacturers of devices regulated by CBER under the PHS Act, i.e., 
manufacturers of licensed in vitro diagnostics including donor screening tests, 
should follow the registration and listing requirements in 21 CFR 
607.20 and refer to the section Product Codes for Licensed Devices in 
CBER later in this guidance. 
 
C.  Enforcement Discretion 
 
Devices for which FDA applies enforcement discretion and therefore pre-market review 
is not necessary, require additional instructions before they can be listed in 
FURLS/DRLM. You should contact the Registration and Listing Staff by email at 
reglist@cdrh.fda.gov to obtain the additional instructions prior to attempting to list such 
a device. A few devices for which FDA applies enforcement direction are certain kits 
and export only devices. 
 
i.  Convenience Kits 
    Contains Nonbinding Recommendations 
 
 
You should consider the questions in the following flowchart before listing 
a convenience kit: 
 
 
Does the convenience kit meet the requirements listed in the 
Convenience Kit Interim Regulatory Guidance Document  NO 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuida
nce/GuidanceDocuments/ucm080216.htm? 
  You may not list the 
YES  classification product 
code using a kit code. 
Is the convenience kit of a type matching 
NO 
Each item in the kit will 
one of those included on the list attached to 
have to be listed 
the guidance document? 
separately using a 510(k) 
YES 
  or exempt classification 
Search the Product Classification database  product code.   
(http://www.accessdata.fda.gov/scripts/cdr
h/cfdocs/cfPCD/classification.cfm) to 
determine the product code for your kit.   
 
Did you find a product code that matches 
the description of your convenience kit? 
YES  NO 
Once you determine the product code,  If you are unable to find a product code 
please contact the Registration and  for your kit, please contact the Program 
Listing Staff by email at  Operation Staff in the Office of Device 
reglist@cdrh.fda.gov for assistance with  Evaluation (ODE) at (301) 796-5640 to 
listing your kit.  obtain a product code for your kit.  
   
 
 
 
 
    Contains Nonbinding Recommendations 
 
ii.  US Manufacturers of Export Only Devices 
 
US manufacturers of Export Only Devices are required to list the devices 
that they export to a foreign country.7  However, 510(k) clearance or 
PMA/HDE approval is not needed for the device to be exported to the 
foreign country. Some manufacturers of export only devices may market 
the same device in the United States. In this case, the manufacturer uses the 
classification product code assigned to the cleared/approved device to list 
their device in FURLS/DRLM. If the manufacturer is not marketing the 
same device in the United States, they should contact the Program 
Operations Staff and obtain a new classification product code for export 
only. Once a new classification product code is assigned, please contact 
the Registration and Listing Staff by email at reglist@cdrh.fda.gov for 
assistance with listing devices that are being exported to a foreign country. 
 
Product Codes for Licensed Devices in CBER 
 
CBER regulates a range of devices, most of which are subject to the FD&C Act only. However, 
some CBER devices are licensed under the PHS Act (e.g., in vitro diagnostic tests required for 
blood donor screening and related blood banking practices). Consequently, licensed devices are 
subject to the regulations outlined in 21 CFR Part 600 in addition to those in 21 CFR Part 800. 
The different regulatory requirements impact classification product codes as well. 
 
In contrast, product codes for licensed devices are generated using the principles which apply to 
most other FDA regulated products (please refer to the Import section). As is the case with other 
biologics, licensed devices are classified under industry code 57. For example, a licensed blood 
donor screening assay for Hepatitis B surface antigen has a six character product code of the 
following structure: 57 V H-05. Of note, the letter in the subclass element can either be an H, I or 
L, depending whether this is a final product, intended for further manufacture or product sample 
for testing/lot release. 
 
 
                                                           
7 See 21 CFR Part 807 
    Contains Nonbinding Recommendations 
 
 
Appendix A.  Frequently Asked Questions 
 
 
1.  I have a device for export only. I cannot find the appropriate classification product code in 
the classification database, how would I be able to successfully list the device? 
 
Answer: You should contact the Program Operations Staff in order to have a new product 
code created for the intent of export only. 
 
2.  How do I search for a classification product code? 
 
Answer: You can search for a product code using the Product Classification Database on 
FDAs website: 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm 
 
3.  I have searched the product code database and do not find a suitable classification product 
code for my device. What should I do? 
 
Answer: You can contact the appropriate review division within CDRH/CBER. You may 
also submit a Request for Classification (513(g)) application.8 
 
4.  How do I update/change a classification product code? 
 
Answer: Contact the Product Code Coordinator at 301-796-5640. 
 
5.  What do I do if the classification product code on my 510(k) substantially equivalent (SE) 
or PMA approval letter is incorrect? 
 
Answer: Contact the appropriate review division within CDRH/CBER. The contact 
information will be at the bottom of the SE letter or approval letter. If the classification 
product code is incorrect, they will make the correction and send you a corrected 
clearance or approval letter. 
 
6.  What happens to the classification product code when the device is reclassified? 
 
Answer: The product code database will be updated to reflect the new information and the 
affected firms will be notified in writing in a timely manner. 
 
7.  What should I do if I notice an error in the product classification database? 
                                                           
8 Refer to the Guidance for Industry and FDA Staff: FDA and Industry Procedures for Section 513(g) Requests for 
Information under the Federal Food, Drug, and Cosmetic Act on FDAs website: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm209841.htm; and the 
Guidance for Industry and FDA Staff: User Fees for 513(g) Requests for Information: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm209852.htm 
    Contains Nonbinding Recommendations 
 
 
Answer:  Contact the product code coordinator at 301-796-5640 and the database will be 
corrected.  The product classification database found at 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm  is 
updated weekly.  
 
8.  What is the difference in review time if a submission requires the creation of a new  
product code? 
 
Answer:  There is no difference in the review time when a new product code is needed. 
 
9.  Does FDA work with the Centers for Medicare and Medicaid Services (CMS) on 
product codes for reimbursement issues? 
 
Answer: No. FDA will provide information to CMS regarding the regulatory 
requirements associated with a specific product code, but is not further involved in the 
reimbursement process.  For reimbursement issues, CMS should be contacted directly.9  
 
10. Is it helpful to include a classification product code on my adverse event report? 
 
Answer: Absolutely, it improves the quality of data reporting and appropriate routing of 
the report for analysis. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
9 See https://www.cms.gov/.   
    Contains Nonbinding Recommendations 
 
 
Appendix B.  Resources 
 
 
Program Operations Staff/Office of Device Evaluation 
301-796-5640 
 
Product Classification Database 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm 
 
Office of Regulatory Affairs (ORA) Product Code Builder 
http://www.accessdata.fda.gov/scripts/ora/pcb/pcb.htm 
 
Device Advice  Device Regulation and Guidance 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm 
 
Device Classification 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDe
vice/default.htm   
 
Medical Device Listing http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm 
 
Convenience Kits Guidance 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm
080216.htm   
 
Medical Device Reporting (MDR) 
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 
 
Industry Procedures for Section 513(g) Requests for Information 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm
209841.htm   
 
Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff (De 
Novo) 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm
080195.htm