FDA

Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s1 and Premarket Approvals2

Classify Your Medical Device

Introduction

 How To Determine Classification

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Introduction

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and

effectiveness of the device. The three classes and the requirements which apply to them are:

Device Class and Regulatory Controls

1. Class I General Controls

o With Exemptions o Without Exemptions

2. Class II General Controls and Special Controls

o With Exemptions o Without Exemptions

3. Class III General Controls and Premarket Approval

The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA

clearance to market. If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing. All devices classified as exempt are subject to the limitations on exemptions. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892. For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA's have not been called for. In that case, a 510k will be the route to market.

Device classification depends on the intended use of the device and also upon indications for use. For example, a scalpel's intended use is to cut tissue. A subset of intended use arises when a more specialized indication is added in the device's labeling such as, \"for making incisions in the cornea\". Indications for use can be found in the device's labeling, but may also be conveyed orally during sale of the product. A discussion of the meaning of intended use is contained in Premarket Notification Review Program K86-33.

In addition, classification is risk based, that is, the risk the device poses to the patient and/or the user is a major factor in the class it is assigned. Class I includes devices with the lowest risk and Class III includes those with the greatest risk.

As indicated above all classes of devices as subject to General Controls. General Controls are the baseline requirements of the Food, Drug and Cosmetic (FD&C) Act that apply to all medical devices, Class I, II, and III.

How to Determine Classification

To find the classification of your device, as well as whether any

exemptions may exist, you need to find the regulation number that is the classification regulation for your device. There are two methods for accomplishing this: go directly to the classification database4 and search for a part of the device name, or, if you know the device panel5 (medical specialty) to which your device belongs, go directly to the listing for that panel and identify your device and the corresponding regulation. You may make a choice now, or continue to read the background information below. If you continue to read, you will have another chance to go to these destinations.

If you already know the appropriate panel you can go directly to the CFR and find the classification for your device by reading through the list of classified devices, or if you're not sure, you can use the keyword directory in the PRODUCT CODE CLASSIFICATION DATABASE6. In most cases this database will identify the classification regulation in the CFR. You can also check the classification regulations7 below for information on various products and how they are regulated by CDRH.

Each classification panel in the CFR begins with a list of devices classified in that panel. Each classified device has a 7-digit number

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associated with it, e.g., 21 CFR 880.2920 - Clinical Mercury Thermometer. Once you find your device in the panel's beginning list, go to the section indicated: in this example, 21 CFR 880.29209 . It describes the device

and says it is Class II. Similarly, in the Classification Database under \"thermometer\

thermometers. The three letter product code, FLK in the database for Clinical Mercury Thermometer, is also the classification number which is used on the Medical Device Listing form.

Once you have identified the correct classification regulation go to What are the Classification Panels10 below and click on the correct

classification regulation or go to the CFR Search page11. Some Class I devices are exempt from the premarket notification and/or parts of the good manufacturing practices regulations. Approximately 572 or 74% of the Class I devices are exempt from the premarket notification process. These exemptions are listed in the classification regulations of 21 CFR and also has been collected together in the Medical Device Exemptions12 document.

Device Classification Panels

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What are the Classification Panels

How to Locate Classification Regulations Where to Proceed From Classification

What are the Classification Panels

Most medical devices can be classified by finding the matching description of the device in Title 21 of the Code of Federal Regulations (CFR), Parts 862-892. FDA has classified and described over 1,700 distinct types of devices and organized them in the CFR into 16 medical specialty \"panels\" such as Cardiovascular devices or Ear, Nose, and Throat devices. These panels are found in Parts 862 through 892 in the CFR. For each of the devices classified by the FDA the CFR gives a general description

including the intended use, the class to which the device belongs (i.e., Class I, II, or III), and information about marketing requirements. Your device should meet the definition in a classification regulation contained in 21 CFR 862-892.

How to Locate Classification Regulations 8681 Anesthesiology 8702 Cardiovascular

8623 Clinical Chemistry and Clinical Toxicology 8724 Dental

8745 Ear, Nose, and Throat 8766 Gastroenterology and Urology 8787 General and Plastic Surgery 8808 General Hospital and Personal Use 8649 Hematology and Pathology 866 10Immunology and Microbiology 88211 Neurology

88412 Obstetrical and Gynecological 88613 Ophthalmic 88814 Orthopedic 890 15Physical Medicine 89216 Radiology

Where to Proceed From Classification

If your device requires premarket notification [510(k)] proceed to the Premarket Notification [510(k)] page. For Class I devices exempt from [510(k)] the submission of a [510(k)] and marketing clearance from FDA is not required. If your Class I (or certain class II) device is exempt, subject to the limitations on exemptions, from the 510(k) process, this

will be stated in the classification regulation. However, other General Controls such as registration and listing17, labeling18, and good

manufacturing practices19 apply. If you have a Class III device requiring premarket approval (PMA) proceed to Premarket Approval (PMA) page.

Market submission options

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510(k)20 PMA21 Exempt22

Premarket Notification (510k)

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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 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 8071 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:

   

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;

o does not raise new questions of safety and effectiveness; and

o 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:

o resubmit another 510(k) with new data,

o request a Class I or II designation through the de novo process o file a reclassification petition, or

o submit a premarket approval application (PMA).

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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.

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 Device4.\" 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 8075) 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?6 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 Exemption7 (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 801.18) and sell it to end users without submission of a 510(k).

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 Status9. 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 Requirements10. 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 Status11 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 Information12 page.

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References

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510(k) Frequently Asked Questions13

New Section 513(f)(2) - Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff14

510(k) Substantial Equivalence Decision Making Process Flow Chart Detailed (PDF - 31KB)15

Guidance on the CDRH Premarket Notification Review Program 6/30/86 (K86-3)16 Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1)17 Preamendment Status18

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Additional Information

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510(k) Clearances19