12/8/2015
`
`Premarket Notification 510(k)
`
`U.S. Food and Drug Administration
`Protecting and Promoting Your Health
`
`Premarket Notification 510(k)
`
`Introduction
`What is Substantial Equivalence
`Who is Required to Submit a 510(k)
`When a 510(k) is Required
`When a 510(k) is not Required
`Preamendment Devices
`Third Party Review Program
`
`Introduction
`Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is
`not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic
`Act (the Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21
`CFR 864.9). There is no 510(k) form, however, 21 CFR 807
`(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=807&showFR=1&subpartNode=21:8.0.1.1.5.5)
`Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter must receive an order, in the form of
`a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This
`order "clears" the device for commercial distribution.
`
`A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is,
`substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Submitters must compare their
`device to one or more similar legally marketed devices and make and support their substantial equivalency claims. A legally marketed
`device, as described in 21 CFR 807.92(a)(3), is a device that was legally marketed prior to May 28, 1976 (preamendments device), for
`which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found SE
`through the 510(k) process. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although
`devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device
`may be used as a predicate. Legally marketed also means that the predicate cannot be one that is in violation of the Act.
`
`Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device. Once the device is
`determined to be SE, it can then be marketed in the U.S. The SE determination is usually made within 90 days and is made based on the
`information submitted by the submitter.
`
`Please note that FDA does not perform 510(k) pre-clearance facility inspections. The submitter may market the device immediately after
`510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after
`510(k) clearance.
`
`What is Substantial Equivalence
`A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that
`the new device is at least as safe and effective as the predicate.
`
`A device is substantially equivalent if, in comparison to a predicate it:
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`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/
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`Ex. 2033-0001
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`has the same intended use as the predicate; and
`has the same technological characteristics as the predicate;
`or
`has the same intended use as the predicate; and
`has different technological characteristics and the information submitted to FDA;
`does not raise new questions of safety and effectiveness; and
`demonstrates that the device is at least as safe and effective as the legally marketed device.
`
`A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established
`with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance,
`safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.
`
`A device may not be marketed in the U.S. until the submitter receives a letter declaring the device substantially equivalent. If FDA
`determines that a device is not substantially equivalent, the applicant may:
`
`resubmit another 510(k) with new data,
`request a Class I or II designation through the de novo
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm462775.htm) process
`file a reclassification petition (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?
`CFRPart=860&showFR=1&subpartNode=21:8.0.1.1.15.3), or
`submit a premarket approval application (PMA).
`
`Who is Required to Submit a 510(k)
`The Act and the 510(k) regulation (21 CFR 807) do not specify who must apply for a 510(k). Instead, they specify which actions, such as
`introducing a device to the U.S. market, require a 510(k) submission.
`
`The following four categories of parties must submit a 510(k) to the FDA:
`
`1. Domestic manufacturers introducing a device to the U.S. market;
`
`Finished device manufacturers must submit a 510(k) if they manufacture a device according to their own specifications and market it in
`the U.S. Accessories to finished devices that are sold to the end user are also considered finished devices. However, manufacturers of
`device components are not required to submit a 510(k) unless such components are promoted for sale to an end user as replacement
`parts. Contract manufacturers, those firms that manufacture devices under contract according to someone else’ s specifications, are
`not required to submit a 510(k).
`2. Specification developers introducing a device to the U.S. market;
`
`A specification developer develops the specifications for a finished device, but has the device manufactured under contract by another
`firm or entity. The specification developer submits the 510(k), not the contract manufacturer.
`3. Repackers or relabelers who make labeling changes or whose operations significantly affect the device.
`
`Repackagers or relabelers may be required to submit a 510(k) if they significantly change the labeling or otherwise affect any condition
`of the device. Significant labeling changes may include modification of manuals, such as adding a new intended use, deleting or
`adding warnings, contraindications, etc. Operations, such as sterilization, could alter the condition of the device. However, most
`repackagers or relabelers are not required to submit a 510(k).
`4. Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market.
`
`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/
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`2/6
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`Ex. 2033-0002
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`Premarket Notification 510(k)
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`Please note that all manufacturers (including specification developers) of Class II and III devices and select Class I devices are required to
`follow design controls (21 CFR 820.30) during the development of their device. The holder of a 510(k) must have design control
`documentation available for FDA review during a site inspection. In addition, any changes to the device specifications or manufacturing
`processes must be made in accordance with the Quality System regulation (21 CFR 820) and may be subject to a new 510(k). Please see
`our guidance, "Deciding When to Submit a 510(k) for a Change to an Existing Device
`(/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm)."
`
`When a 510(k) is Required
`A 510(k) is required when:
`
`1. Introducing a device into commercial distribution (marketing) for the first time. After May 28, 1976 (effective date of the Medical Device
`Amendments to the Act), anyone who wants to sell a device in the U.S. is required to make a 510(k) submission at least 90 days prior
`to offering the device for sale, even though it may have been under development or clinical investigation before that date. If your
`device was not marketed by your firm before May 28, 1976, a 510(k) is required.
`2. You propose a different intended use for a device which you already have in commercial distribution. The 510(k) regulation (21 CFR
`807 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?
`CFRPart=807&showFR=1&subpartNode=21:8.0.1.1.5.5)) specifically requires a 510(k) submission for a major change or
`modification in intended use. Intended use is indicated by claims made for a device in labeling or advertising. Most, if not all changes
`in intended use will require a 510(k). Please note that prescription use to over the counter use is a major change in intended use and
`requires the submission of a new 510(k).
`3. There is a change or modification of a legally marketed device and that change could significantly affect its safety or effectiveness. The
`burden is on the 510(k) holder to decide whether or not a modification could significantly affect safety or effectiveness of the device.
`Any modifications must be made in accordance with the Quality System regulation, 21 CFR 820, and recorded in the device master
`record and change control records. It is recommended that the justification for submitting or not submitting a new 510(k) be recorded in
`the change control records.
`
`A new 510(k) submission is required for changes or modifications to an existing device, where the modifications could significantly
`affect the safety or effectiveness of the device or the device is to be marketed for a new or different indication for use. See Is a new
`510(k) required for a modification to the device?
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k
`/ucm134575.htm) for additional information.
`
`When a 510(k) is Not Required
`The following are examples of when a 510(k) is not required.
`
`1. You sell unfinished devices to another firm for further processing or sell components to be used in the assembling of devices by other
`firms. However, if your components are to be sold directly to end users as replacement parts, a 510(k) is required.
`2. Your device is not being marketed or commercially distributed. You do not need a 510(k) to develop, evaluate, or test a device. This
`includes clinical evaluation. Please note that if you perform clinical trials with your device, you are subject to the Investigational
`Device Exemption
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm)
`(IDE) regulation (21 CFR 812).
`3. You distribute another firm's domestically manufactured device. You may place a label on the device, "Distributed by ABC Firm" or
`"Manufactured for ABC Firm," (21 CFR 801.1 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?
`fr=801.1)) and sell it to end users without submission of a 510(k).
`
`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/
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`3/6
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`Ex. 2033-0003
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`Premarket Notification 510(k)
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`4. In most cases, if you are a repackager or a relabeler you are not required to submit a 510(k) if the existing labeling or condition of the
`device is not significantly changed. The labeling should be consistent with the labeling submitted in the 510(k) with the same
`indications for use and warnings and contraindications.
`5. Your device was legally in commercial distribution before May 28, 1976 and you have documentation to prove this. These devices are
`"grandfathered" and have Preamendment Status
`(/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/ucm379552.htm). You do not have to
`submit a 510(k) unless the device has been significantly modified or there has been a change in its intended use.
`6. The device is made outside the U.S. and you are an importer of the foreign made medical device. A 510(k) is not required if a 510(k)
`has been submitted by the foreign manufacturer and received marketing clearance. Once the foreign manufacturer has received
`510(k) clearance for the device, the foreign manufacturer may export his device to any U.S. importer.
`7. Your device is exempted from 510(k) by regulation (21 CFR 862-892). That is, certain Class I or II devices can be marketed for the first
`time without having to submit a 510(k). A list of the Class I and II exempted devices can be found on Medical Device Exemptions
`510(k) and GMP Requirements (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm). However, if the device
`exceeds the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9), such
`as the device has a new intended use or operates using a different fundamental scientific technology than a legally marketed device in
`that generic type of device, or the device is a reprocessed single-use device, then a 510(k) must be submitted to market the new
`device.
`
`Preamendment Devices
`The term "preamendments device" refers to devices legally marketed in the U.S. by a firm before May 28, 1976 and which have not been:
`
`significantly changed or modified since then; and
`for which a regulation requiring a PMA application has not been published by FDA.
`
`Devices meeting the above criteria are referred to as "grandfathered" devices and do not require a 510(k). The device must have the same
`intended use as that marketed before May 28, 1976. If the device is labeled for a new intended use, then the device is considered a new
`device and a 510(k) must be submitted to FDA for marketing clearance.
`
`Please note that you must be the owner of the device on the market before May 28, 1976, for the device to be grandfathered. If your
`device is similar to a grandfathered device and marketed after May 28, 1976, then your device does NOT meet the requirements of being
`grandfathered and you must submit a 510(k). In order for a firm to claim that it has a preamendments device, it must demonstrate that its
`device was labeled, promoted, and distributed in interstate commerce for a specific intended use and that intended use has not changed.
`See Preamendment Status
`(/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/ucm379552.htm) for information on
`documentation requirements.
`
`Third Party Review Program
`The Center for Devices and Radiological Health (CDRH) has implemented a Third Party Review Program. This program provides an option
`to manufacturers of certain devices of submitting their 510(k) to private parties (Recognized Third Parties) identified by FDA for review
`instead of submitting directly to CDRH. For more information on the program, eligible devices and a list of Recognized Third Parties go to
`Third Party Review Program Information
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ThirdParyReview/default.htm)
`page.
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`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/
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`Ex. 2033-0004
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`References
`
`Premarket Notification 510(k)
`
`CDRH Learn Module: 510(k) Program (http://fda.yorkcast.com/webcast/Play/d91af554691c4260b5eca0b2a28e636b1d)
`(/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm)
`
`510(k) Frequently Asked Questions
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm142654.htm)
`New Section 513(f)(2) - Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff
`(/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080195.htm)
`
`510(k) Decision-Making Flowchart
`(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284443.pdf#page=30)
`The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] - Guidance for Industry and Food and Drug
`Administration Staff (PDF - 844KB) (/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284443.pdf)
`
`Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1)
`(/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm)
`
`Additional Information
`
`510(k) Clearances (/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/default.htm)
`
`Contact FDA
`
`1-800-638-2041
`301-796-7100
`DICE@fda.hhs.gov (mailto:DICE@fda.hhs.gov)
`
`CDRH-Division of Industry and Consumer Education (DICE)
`Office of Communication and Education
`Center for Devices and Radiological Health
`Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`
`More in Premarket Notification (510k)
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm)
`
`510(k) Submission Process
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm)
`
`510(k) Forms
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070202.htm)
`
`510(k) Submission Methods
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134034.htm)
`
`How To Prepare A Special 510(k)
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134573.htm)
`
`How to Find and Effectively Use Predicate Devices
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134571.htm)
`
`How to Prepare a Traditional 510(k)
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134572.htm)
`
`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/
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`5/6
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`Ex. 2033-0005
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`12/8/2015
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`Premarket Notification 510(k)
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`How to Prepare an Abbreviated 510(k)
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134574.htm)
`
`Is a new 510(k) required for a modification to the device?
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134575.htm)
`
`Premarket Notification [510(k)] Review Fees
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134566.htm)
`
`Special Considerations
`(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134578.htm)
`
`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/
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`6/6
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`Ex. 2033-0006