FDA Consultant Needed for Class I Medical Device Development

[SmallBizInventor]

I have designed and will be contract-manufacturing a device for which I would like to receive Class I exempt status. (I say Class I exempt based on the existence of predicate devices which were also determined to be exempt after submission of their 510(k).) This is a simple non-sterile non-electronic device.

I would appreciate any advice as to how I might locate a consultant who can help with regulatory issues, such as developing proper procedures and QA that will be needed by the FDA, and preparing a 510(k) for a simple Class I device. I can (and will) post to craigslist but I was wondering if there are other more selected forums to search in. Thank you.

 

[MIREGMGR]

Re: FDA Consultant Needed for Class I Device Development

I would appreciate any advice as to how I might locate a consultant who can help with regulatory issues, such as developing proper procedures and QA that will be needed by the FDA, and preparing a 510(k) for a simple Class I device.

A posting here, such as the one you just did, is likely to result in various consultants responding directly to you via PM.

I was wondering if there are other more selected forums to search in.

I don't think there's any forum that's superior to here. Of course, in the end, wherever you find the help you need will be the location that you'll think is superior.

You might be able to obtain the regulatory help you want from the same outfit that does your contract manufacturing. There can be advantages in such an approach, since communications and controls regarding materials choices, biocompatibility issues, etc. are not a problem.

On the other hand, you as the regulatorily responsible Manufacturer of the product are obligated to Register, List, and have a 21CFR820-compliant QMS. It's unlikely that a contract manufacturer would be equipped to provide such assistance; a consultant would be a better fit for that work. Or, you might begin to add employees to do that work, as well as prepare for marketing and other business operations.

Are you also considering alternate, easier/cheaper-to-start-up business approaches such as licensing your device to an interested device maker in return for sales royalties or some other arrangement?

I have designed and will be contract-manufacturing a device for which I would like to receive Class I exempt status. (I say Class I exempt based on the existence of predicate devices which were also determined to be exempt after submission of their 510(k).)

Just as a clarification, all Class I devices other than a very few that have special status are Exempt from the 510(k) pre-authorization process. Usually a "Class x Exempt" statement is in regard to a Class II device that fits into a Product Code that has such Exempt status...an example being KXJ, for radiolucent patient support devices such as an imaging table.

Generally speaking, if your identified Predicate Device has a 510(k), your device will as well. If on the other hand your Predicate Device is classified as Class II Exempt, it won't have a 510(k) specifically because it's Exempt from that requirement.

 

[SmallBizInventor]

Re: FDA Consultant Needed for Class I Device Development

Miremgr, thank you very much for your responses. To answer your questions:

1. I am actually doing a hybrid approach, contracting with both non-medical and at least one medical manufacturing company. Per your kind advice, I will ask the company with the most medical experience for help.

2. I am aiming to start this myself rather than license at this point.

3. My device is definitely a Class I device. The predicate device that had the 510(k) submission was considered a Class I exempt device by the FDA (and probably did not even need to submit a 510(k)).

However, my device has novel features that make it differ from predicate devices now in the market. I discussed the issues with a representative from the FDA, and we both thought it best that I submit a 510(k).

I guess the area of most confusion for me is filling out a 510(k) from scratch, simply going by the descriptions of each section on the FDA site. For example, although I am putting many specifications into the Device Description (section 11), nothing on the FDA outline for section 11 mentions a "compliant QMS." So I assume there are numerous additional specific items that are necessary for a complete 510(k) (even for a Class I device), that are not listed on the FDA outline.

If I had access to a complete and approved 510(k) for another Class I device, to use as a reference, it would help, but that has been impossible for me to obtain so far.

Thanks again.

 

[MIREGMGR]

Re: FDA Consultant Needed for Class I Device Development

2. I am aiming to start this myself rather than license at this point.

That's a common perspective. I think you'll find that it's by far the harder course to follow, though perhaps very satisfying if you pull it off.

...nothing on the FDA outline for section 11 mentions a "compliant QMS."

You need the QMS to be the legal party that is regulatorily responsible for a marketed medical device. It's not part of the 510(k) process in a direct sense, but it's very definitely part of marketing your device.

There are a number of other key requirements for a medical device Manufacturer that you probably don't have in place yet either, that don't directly have anything to do with the 510(k) process.

I discussed the issues with a representative from the FDA, and we both thought it best that I submit a 510(k). (...) I guess the area of most confusion for me is filling out a 510(k) from scratch.

There was another post on Elsmar yesterday from someone that in my view didn't need a consultant. In my view, you do need the consultant that you're here to find. You may not have realized yet the scope of the work you're proposing to do. Your consultant will save you a lot of time, minimize some otherwise-substantial risks of failure, and (especially) teach you a lot. It's no fun to put a ton of work into a 510(k) filing and have it rejected, or set up a little company, have the FDA show up at your door for an initial inspection, and have them give you a Form 483 with a long list of Inspectional Observations due to your not having implemented various required steps and systems. Have your consultant show you how all of that needs to be done. You can take over from there, and do the next 510(k) yourself.