Effective Date of Requirement for Premarket Approval for Four Class III Preamendments Devices

The Food and Drug Administration (FDA) is proposing the requirement of a premarket approval (PMA) or a notice of completion of a product development protocol (PDP) for the below devices:
- Ventricular bypass (assist) device
- Pacemaker repair or replacement material
- Female condom
- Transilluminator for breast evaluation

FDA has also summarized its proposed findings for degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. FDA has also asked for request from interested persons to change the classification of any of the above mentioned devices based on new information. The written or electronic comments should be submitted by November 23, 2010 and request for change in classification should be submitted by September 9, 2010.

FDA also confirms that the finalizing of this proposed rule will lead to submission of a PMA (for above devices) within 90 days of effective date of the final rule. A PMA must include valid scientific evidence to demonstrate reasonable assurance of the safety and effectiveness of the device for its intended use as per 21 CFR 860.7(c)(2).

A PDP for any of these devices may be submitted instead of a PMA which required providing following information:
- A description of the device
- Preclinical trial information (if any)
- Clinical trial information (if any)
- A description of the manufacturing and processing of the devices
- The labeling of the device
- All other relevant information about the device and progress reports and records of the trials conducted under the protocol on the safety and effectiveness of the device for which the completed PDP is sought.

Proposed Effective Date: FDA is proposing that any final rule based on this proposal become effective 12 months after the date of its publication in the Federal Register or at a later date if stated in the final rule.

For more information on this issue you can go to the following link: http://edocket.access.gpo.gov/2010/2010-21142.htm.

If you would like to discuss how this will affect your devices e-mail us at info@mdiconsultants.com and reference Class3dev