Bioelectronics Corp (BIEL)

[seven-up]

It is not the response from the FDA, it is your question, I agree it could take up to a year for a device to be approved in the new class, once the class is established and depending on the device.
We are waiting for the new class to set-up.
Then we can submit the 510K
Since the FDA has looked at it and turned it down, hopefully Biel now knows what to do, so I think it will be done by the end of the year. JMPO
Part of FDA Response

The process timeline varies widely depending on the complexity surrounding the particular product type and regulatory history and the volume and types of comments we receive in response to our proposed classification

.

Here is the FDA steps, we are on "D" now

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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