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`Search for FDA Guidance Documents > Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff
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`U.S. Food and Drug Administration
`Protecting and Promoting Your Health
`
`Medical Device Classification
`Product Codes - Guidance for
`Industry and Food and Drug
`Administration Staff
`
`PDF Printer Version
`nloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM285325.pdf)
`Document issued on: April 11, 2013
`
`The draft of this document was issued on January 3, 2012.
`
`For questions regarding this document contact (CDRH) Diane Garcia at 301-796-6559 or
`diane.garcia@fda.hhs.gov (mailto:diane.garcia@fda.hhs.gov), or (CBER) the Office of
`Communication, Outreach and Development at 800-835-4709 or 301-827-1800.
`
`U.S. Department of Health and Human Services
`Food and Drug Administration
`Center for Devices and Radiological Health
`Center for Biologics Evaluation and Research
`
`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
`(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.
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`Additional Copies
`Additional copies are available from the Internet. You may also send an e-mail request to CDRH-
`Guidance@fda.hhs.gov (mailto:CDRH-Guidance@fda.hhs.gov) to receive a copy of the
`guidance. 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,
`(mailto:ocod@fda.hhs.gov)or from the Internet at
`http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/de
`fault.htm
`(http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/d
`efault.htm).
`
`Table of Contents
`
`Introduction
`Definition
`Use of Classification Product Codes in Premarket Review
`Use of Classification Product Codes in Post Market Review
`Product Codes for Licensed Devices in CBER
`Appendix A. Frequently Asked Questions
`Appendix B. Resources
`
`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
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`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 Health’s (CDRH’s) 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 FDA’s 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 panels. It
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`also covers unclassified devices and devices not yet classified.
`
`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.
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`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 device’s 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.
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`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 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
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`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 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
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`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
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`assigned when the 510(k) was submitted and determined to be NSE will be used. Note
`that Section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA)
`amended Section 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 FDA’s Convenience Kits Interim Regulatory Guidance
`(/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.
`htm). The list of established convenience kits can be found in the guidance.
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`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
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`can be submitted to CDRH or CBER.
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`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 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
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`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. FDA’s 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.
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`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 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
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`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/default.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, ORA’s
`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 CDRH’s Product Classification Database. However, ORA’s 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 CDRH’s Product Classification Database. The same
`product code translates to 80F--RN in ORA’s 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
`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 device’s marketing
`status, since the product code is assigned during pre-market review or approval (510(k), PMA,
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`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
`4
`by FDA for the purposes of registration and listing. Step- by-step instructions on determining how
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`FDA will classify your device can be found on the FDA website. 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 (mailto:dsmica@fda.hhs.gov) to receive assistance.
`
`B. Listing Your Device
`6
`Instructions for listing your device are posted on our website under the “Initial Registration”
`heading.
`
`i. Exempt Devices
`
`Devices that are notsubject 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 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:
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`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
`(mailto: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
`
`You should consider the following before listing a convenience kit:
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`ii. US Manufacturers of Export Only Devices
`
`US manufacturers of Export Only Devices are required to list the devices that they export to a
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`foreign country. 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 (mailto:reglist@cdrh.fda.gov) for assistance with listing devices
`that are being exported to a foreign country.
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`Product Codes for Licensed Devices in CBER
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`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.
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`Back to the top
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`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 FDA’s
`website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm
`(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
`8
`submit a Request for Classification (513(g)) application.
`
`4. How do I update/change a classification product code?
`
`Answer: Contact the Product Code Coordinator at 301-796-5640.
`
`http://www.fda.gov/RegulatoryInformation/Guidances/ucm285317.htm
`
`13/17
`
`Ex. 2034-0013
`
`

`
`12/8/2015
`
`Search for FDA Guidance Documents > Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff
`
`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?
`
`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
`(http:/