Bioelectronics Corp (BIEL)

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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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Page Last Updated: 06/03/2014