Labelling for 510K submission for a Class II medical device - suture passer

[ElmerF]

I am shortly to submit a 510K for a Class II device, suture passer.
General Program Memorandum #G91-1 seems to indicate that only PMA devices require the Caution: Federal law restricts this device to sale, distribution and use by or on the order of a physician (part IX and X)

Am I safe in omitting this from my draft labeling?

What about UDI? We will be introducing shortly for the EU market and the US draft label contains a UDI barcode. Should I submit or wait until it becomes mandatory?


Thanks,

Elmer

 

[MIREGMGR]

A device of any class requires an Rx Only statement if (paraphrasing) it is only safe and effective when used by or under the supervision of an appropriately trained medical professional.

I'd guess that a suture passer would not be considered inherently safe for lay use, and that you do not include Instructions for Use with the product that are intended to instruct lay users in its safe and effective use.

 

[ElmerF]

Excellent. Thank you!

 

[MIREGMGR]

On UDI, I'd wait until the guidance is final. FDA is still figuring out what the final rule will be.