FDA Classification of Medical Devices

The U.S. FDA (The Food and Drug Administration) classifies medical devices into 16 categories totalling more than 1,700 types. Each different type of medical device is divided into three classes according to the level of safety and effectiveness control necessary. The three classes are categorised as follows:

Device Classes and Regulatory Controls

1. Class I, General Regulation

(1) with exemption; (2) without exemption

2, II level, general regulation and special regulation

(1) with exemption; (2) without exemption

3、III, general regulation and pre-market approval

Classification level of medical devices is the FDA approval of its marketing before the submission of application materials based on Class I or Class II medical devices, if the type of regulation is not exempted medical devices, pre-market need to be through the FDA 510K content review; exempted devices only need to comply with exemptions from restrictions on the content of the requirements can be. The exempted content is in accordance with 21 CFR xxx.9 (Code of Federal Regulations Title 21), where xxx refers to the content of sections 862-892 of 21 CFR. For all Class III medical devices, a Premarket Approval Application (PMA premarket approvalapplication) is required unless the medical device is a medical device that was on the market prior to the passage of the Medical Device Amendments of 1976, or is similar to a medical device in that class. In this case, compliance with Section 510K requirements will allow marketing.

The classification of medical devices in the United States depends on their intended use and instructions for use. For example, the intended use of a surgical scalpel is to cut tissue. However, adding additional functions to the medical device requires a specific description to be added to the label of the medical device, such as making an incision in the cornea. The function for which the medical device is to be used needs to be found on the labelling of the device, or it can be presented verbally during the sale of the product. Requirements for instructions for use of medical devices are detailed in the 510K, e.g. link [The 510(k) Program: Evaluating SubstantialEquivalence in Premarket Notification [510(k)].

Classification of medical devices in the United States is based on risk assessment, and the risk of the device to the patient or user is the primary basis for its classification. class I medical devices are the lowest risk class, and class III medical devices are the highest risk class. All medical devices must comply with routine regulatory content, which is the basic requirement that the FDA must meet for all medical devices, including Class I/II/III.

How Classification is Determined

Medical device classification rules determine whether a medical device has a premarket exemption. There are two ways to confirm this, either by searching the name of the medical device directly from the classification database to determine the classification rules, or by using the functional characteristics of the medical device to directly confirm the classification rules of the medical device and categorise and analyse it.

If the functional characteristics of medical devices are known, you can directly find the classification criteria in the CFR database, if you can not determine the need to search through the name of the medical device keywords in the product code database to find the classification confirmation [link to PRODUCT CODE CLASSIFICATION DATABASE], in most cases, the database is able to identify the classification in the CFR In most cases, the database identifies the classification rules in the CFR, and can also be used to review and compare classification rules with information on other products to confirm how the CDRH (FDA Center for Devices and Radiological Health) regulates these products.

Each classification group in the CFR is a series of Class I medical devices. Each classified medical device has a 7-digit code number, for example 21 CFR 880.2920 - Clinical mercury thermometers. The code number contains additional information, 21 CFR 880.2920 This code means that it is classified as a Class II medical device. There are also several different types of thermometers in the CFR database under the "Thermometers" subgroup. The three-letter product code FLK in the Clinical Mercury Thermometers database is also the classification number used on the Medical Device List.

To confirm the exact classification rules for a medical device, go to the Medical Device Classification Panel link What are the Classification Panels or go to the CFR search page and click on the exact classification rules. Some Class I medical devices are exempt from premarket announcements or from some of the requirements of Good Manufacturing Practice regulations. These exemptions are reflected in the 21 CFR Classification Rule and can also be found in the Medical Device Exemptions link Medical Device Exemptions.

To obtain an official medical device clearance or classification from the FDA, you need to consider whether you need to submit a 513(g) application. For guidance on how to submit a 513(g) request, refer to the guidance document "FDA and Industry Procedures for Section 513(g) Requestsfor Information under the Federal Food, Drug, and Cosmetic Act Guidance (2012)." For further information, view CDRH's training module 513(g) Requests for InformationExternal Link Disclaimer (where select "How to Study and Market Your Device," subsection "Classification," or "Classification"). " subsection "Classification").

Note that a filing fee is required when submitting a 513(g) request. There are tax credits available for micro and small businesses, which can be found on the Reduced Medical Device User Fees: Small Business Determination (SBD) Program page.