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515 Program Initiative

The 515 Program Initiative: Reclassification of Preamendments Class III 510(k)s


FDA regulates medical devices and categorizes them into one of three classes (I, II or III) based on their level of risk and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Class I and II devices are generally considered to be lower risk devices. Class I devices are typically exempt from submission of a premarket notification, or 510(k). Class II devices typically require FDA clearance of a 510(k) to permit the device to be marketed and sold in the United States (US). Class III devices, which tend to be higher risk and first-of-a-kind devices, require FDA approval in the form of a premarket approval (PMA) application. Please visit the Overview of Device Regulation website for more information about how the FDA regulates medical devices.

When FDA’s medical device regulation program began in the late 1970s, FDA regulated over 170 Class III device types through the 510(k) program, and those devices were never required to submit PMAs, like a typical Class III device. The intent was that FDA’s regulation would be temporary and that, over time, the FDA would reclassify those device types into Class I or II, or sustain the classification in Class III and call for PMA applications. This reclassification process is described in Section 515 of the Federal Food, Drug and Cosmetic Act (FD&C Act).

Over the years, the FDA made significant progress on the original list of 170 devices; however, as of 2009, 26 medical device regulations still required final action. Accordingly, in late 2009, FDA kicked off the 515 Program Initiative to facilitate action on these remaining Class III device types. However, the July 9, 2012 enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) made changes to Sections 513 and 515 of the FD&C Act, modifying the process for taking final administrative action for these remaining devices. Now the FDA must use an administrative order process instead of using rulemaking. Under the new requirements, FDA must issue proposed and final orders to call for PMAs for 515 devices or reclassify them into class II or class I and hold a device classification panel meeting to consider the classification of each of these devices.

The tasks described below refer to the new process for the 515 devices.

515 Process

The FDA must do five things to finalize the classification process for each device type:

Task A: Collect existing scientific information in the public domain and/or from scientific experts in the medical community and assess the risks versus benefits of the medical device type subject to the classification;

Task B: Convene a meeting of the medical device advisory committee (panel) to request input on the classification of the device type;

Task C: Issue a proposed order (proposed classification) reclassifying the device type into Class I or II, or, if retaining the device in class III, calling for PMAs;

Task D: Review and consider comments submitted by the public;

Task E: Issue a final order (final classification) reclassifying the device type into Class I, or II, or, if retaining the device in class III, calling for PMAs.

A more detailed discussion of these tasks follows below.

Task A: Collect Existing Scientific Information and Assess the Risks and Benefits

The FDA may call for scientific information by publishing of a Federal Register (FR) Notice inviting manufacturers of the devices and the public to submit any known relevant safety and effectiveness information on the medical device type under consideration. The FDA will then review the information posted to the Public Docket and consider this information in its analysis. A FR Notice was issued for all 26 pending medical device types as of April 2009. FDA may also choose to solicit information from the public via a Public Docket.

The FDA then forms a team of internal experts with appropriate backgrounds to conduct expert scientific analysis of the available scientific information regarding the safety and effectiveness of the medical device type, to evaluate the scientific merits of reclassification of the device type to Class I or II, or to sustain the classification in Class III.

Task B: Convene a Meeting of the Medical Device Advisory Committee (Panel)

The FDA will hold a public FDA Advisory Committee (or Panel) Meeting to solicit input from panelists, typically physicians or scientists who are experts in the particular subject matter. Panelists will discuss the scientific evidence on the safety and effectiveness of the medical device type (not a specific manufacturer’s device) and members of the public, including medical device manufacturers, also have an opportunity to openly present information at this meeting.

Task C: Issue Proposed Classification Order

The FDA will issue a proposed order in the Federal Register proposing reclassification of the device type into Class I or II, or, if retaining the device in Class III, calling for PMAs. When FDA proposes a Class II designation, FDA will also publish proposed special controls in conjunction with the proposed administrative order.

Members of the public have an opportunity to provide comment in response to FDA’s proposed order. Comments may be related to anything about the proposed classification. For example, the risks and benefits of the device, class in which the device type is proposed to be classified, and/or appropriate special controls.

Task D: Review and Consider Comments

The FDA will review and consider comments made in response to the issuance of the proposed order. The FDA will also consider changes to the proposed classification (and special controls for Class II devices) based on its review of the comments.

Task E: Issue Final Decision

The FDA issues its decision of the final classification (or final order) of the medical device type in the Federal Register. For class II devices, the FDA would also publish final special controls.

It should be noted that while this is considered to be the final decision of the 515 Program Initiative, the device categorization is not necessarily permanent. In the future, as with any other device type, FDA may subsequently choose to change the classification of a medical device type.

For more information about updates, visit the 515 project status webpage.

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