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FDA Update December 18, 2013

Update on Medical Device Reclassification by the FDA in 2013


Clients might be aware of the FDA’s process of reclassifying medical devices. We received a recent update from the FDA and hence would like our clients to known that no medical devices were reclassified during this Fiscal Year 2013.


What is the FDA Reclassification Process?

Devices that were not available on the market before the enactment of the Medical Device Amendments to the FD&C Act, on May 28, 1976 (generally referred to as post-amendments devices), are automatically classified into Class III without any FDA rulemaking process, regardless of the risks they pose.


The reclassification of these devices may be initiated by the FDA itself or it may be in response to a petition from a manufacturer or importer. As with the 513(e) reclassification process described above, in order to change the classification of the device, it is necessary that the proposed new class have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. If the FDA receives a petition requesting a reclassification, it may ask a device classification panel to review the information and make a recommendation on the petition. Once all information has been considered, the FDA will issue an order approving or denying the petition.


If the FDA approves the petition, the order will describe the reasons for reclassification and identify the risks to health (if any) presented by the device type.



Summary of Medical Devices Reclassified Since 2013


On July 9, 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA). Section 608(c) of FDASIA requires the FDA to annually post the number and type of devices reclassified in the previous calendar year. The table below lists all devices that the FDA has reclassified beginning with the calendar year 2013, the first full calendar year after the enactment of FDASIA.

The FDA intends to update the table after each final reclassification.


Year

Device

CFR

Product Code

Final Reclassification of Device

Class III to
Class II or Class I

Class I or
Class II to Class III

Total

Total

2013

n/a

n/a

n/a

n/a

n/a

0

n/a

0



If you have any doubts regarding medical device reclassification process or any updates about reclassification email us at info@mdiconsultants.com and Ref: Reclassification