Hello,
I work at a medical device manufacturer that, among other things, makes replacement parts for Type I and Type II medical devices. Some of these parts are electric power cords and cables for devices with a preexisting 510(k) by other companies. Unfortunately, in our 510(K) for the replacement parts, my predecessor listed our part, the OEM part that it was designed to replace, and the OEM device that is intended to be plugged into. Since the FDA guidance says that, in essence, the labeling must meet be congruent with the 510(k), is there any wiggle room if the OEM releases another device or product line for which our power cords or cables are also suitable? I'm kind of new at this and appreciate any advice on this. Thanks.

Hello,
I work at a medical device manufacturer that, among other things, makes replacement parts for Type I and Type II medical devices. Some of these parts are electric power cords and cables for devices with a preexisting 510(k) by other companies. Unfortunately, in our 510(K) for the replacement parts, my predecessor listed our part, the OEM part that it was designed to replace, and the OEM device that is intended to be plugged into. Since the FDA guidance says that, in essence, the labeling must meet be congruent with the 510(k), is there any wiggle room if the OEM releases another device or product line for which our power cords or cables are also suitable? I'm kind of new at this and appreciate any advice on this. Thanks.I have a few questions.

Why is it unfortunate that your predecessor listed it that way?
What guidance document are you referring to?
Wiggle room for what? Basically, it's not clear to me as to what, exactly, you want to accomplish.

Thanks for the response. Here are the answers to your follow-up questions:
1.) As currently written, the intended use statement seems overly restrictive with respect to use of these cables with future models for which we have demonstrated equivalency and use the same electronics, materials, form and function, etc. I've seen some intended use statements for similar cables that state very simply what they are supposed to do from a function standpoint without referencing the OEM part numbers that they are intended to be hooked up to.
2.) I am referring to FDA's Content of a 510(k) guidance at www.fda.gov/cdrh/devadvice/314312.html
3.) I guess wiggle room wasn't the best descriptor. I am trying to determine if we need to file a new 510(k) whenever we reverse engineer for another cable that will also work with a device developed by the OEM as a replacement / upgrade to a prior device. I'm sorry if this is somewhat confusing- I'm having difficulty describing what my question is without divulging what our actual devices are.

Thanks again for any help that you may be able to give me based upon this (admittedly) poor description.

Thanks for the response. Here are the answers to your follow-up questions:
1.) As currently written, the intended use statement seems overly restrictive with respect to use of these cables with future models for which we have demonstrated equivalency and use the same electronics, materials, form and function, etc. I've seen some intended use statements for similar cables that state very simply what they are supposed to do from a function standpoint without referencing the OEM part numbers that they are intended to be hooked up to.
2.) I am referring to FDA's Content of a 510(k) guidance at www.fda.gov/cdrh/devadvice/314312.html (http://www.fda.gov/cdrh/devadvice/314312.html)
3.) I guess wiggle room wasn't the best descriptor. I am trying to determine if we need to file a new 510(k) whenever we reverse engineer for another cable that will also work with a device developed by the OEM as a replacement / upgrade to a prior device. I'm sorry if this is somewhat confusing- I'm having difficulty describing what my question is without divulging what our actual devices are.

Thanks again for any help that you may be able to give me based upon this (admittedly) poor description.The intended use or indications for use should be as broad as possible. Look at your competitors' statements in their 510(k) summaries.

Thanks. I appreciate your help.