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DCONN1
I have a question about what is perhaps a unique situation involving shifting classification of a device from Class II to Class I. My apologies, as this may be very difficult to explain without giving specifics;
A company owns a device which was cleared via a 510(k) submission. It was determined to be a Class II device based upon its indications for use, which encompassed a "general" use as well as an additional "specialized" use. Many years subsequent to clearance, the company decides that it would like to market the product with only the general use indications and drop the specialized use indication. This decision is made not based upon risk management concerns; the company makes this decision based upon the fact that this product is being used on the market exclusively for the general use indications, with the market for the product being used for its specialized indications being negligible to non-existent.
By marketing the product without its specialized indications, the device would be classified as Class I; it is only the inclusion of the specialized indication which causes it to be classified as Class II. As a benefit, by marketing the device without its specialized indication and thus re-classifying as Class I, the company can potentially greatly reduce the regulatory burden in countries around the world which use an FDA-equivalency registration pathway.
My questions are:
- Is this down-classification allowed to be done under the regulations? Is there any formal procedure involved other than internal documentation and listing the product on FURLS as a Class I device?
- I would assume that the company would need to recall the product on the market with labeling which includes the specialized indications for use. Would there be any other potential significant downsides to doing this?
A company owns a device which was cleared via a 510(k) submission. It was determined to be a Class II device based upon its indications for use, which encompassed a "general" use as well as an additional "specialized" use. Many years subsequent to clearance, the company decides that it would like to market the product with only the general use indications and drop the specialized use indication. This decision is made not based upon risk management concerns; the company makes this decision based upon the fact that this product is being used on the market exclusively for the general use indications, with the market for the product being used for its specialized indications being negligible to non-existent.
By marketing the product without its specialized indications, the device would be classified as Class I; it is only the inclusion of the specialized indication which causes it to be classified as Class II. As a benefit, by marketing the device without its specialized indication and thus re-classifying as Class I, the company can potentially greatly reduce the regulatory burden in countries around the world which use an FDA-equivalency registration pathway.
My questions are:
- Is this down-classification allowed to be done under the regulations? Is there any formal procedure involved other than internal documentation and listing the product on FURLS as a Class I device?
- I would assume that the company would need to recall the product on the market with labeling which includes the specialized indications for use. Would there be any other potential significant downsides to doing this?