Timing on 510(k) filing - New medical device

[potato124]

Hello,
We are working on a new med device at a startup. I currently am planning on filing the 510(k) AFTER I have all of the equipment in place, and would make the 510(k) submission a subset of my design verification testing (this is how we did it in a big med device company). However, now I am in startup mode and may need to re-sequence due to funding.

I am currently manufacturing all of my prototypes from third party vendors, whose processes will eventually be brought in-house. I believe I can maintain some level of control over their processes and should be able to obtain proper documentation. My question is can I file a 510k based upon product made by third party vendors, then re-perform design verification once all processes are transferred in house? Once transferred, are any additional filings required by the FDA?

Thanks,
potato124

[Coury Ferguson]

Any comments?

[Ajit Basrur]

Hi potato124,

Your question seems to be tricky but dont worry - we will have some answers for you

Any takers pl ?

[treesei]

The focus of 510k submission is to establish the SE between the new and the predicate devices. Process control is of secondary importance (we have 21 CFR 820 to deal with good manufacturing practice). As long as your design is locked in place, you can submit no matter who is making it. After you transfer the manufacturing process to your own facility, you can use FDA's guidance (available from the FDA website) to determine whether you need to do a modification submission.

[MIREGMGR]

In Reply to Parent Post by treesei

The focus of 510k submission is to establish the SE between the new and the predicate devices. Process control is of secondary importance (we have 21 CFR 820 to deal with good manufacturing practice). As long as your design is locked in place, you can submit no matter who is making it. After you transfer the manufacturing process to your own facility, you can use FDA's guidance (available from the FDA website) to determine whether you need to do a modification submission.

In some instances, for devices where performance and therefore safety and effectiveness are determined by materials and manufacturing processes, a significant amount of work and cost will be needed to get that outside-vendor 510(k), and some or all of that work will have to be re-done if new materials and processes are introduced.

The safety and effectiveness of a Class II KKX/MMP surgical drape or equipment cover, for instance, is substantially related to materials performance (biocompatibility, flammability, etc.) and the construction seam-joining techniques.

It may be that the economics of doing that work twice will be relevant to the decisions involved.

[ivanraqa]

It can be tricky for a startup to be fully in control of all the manufacturing processes if they have to be outsourced. One thing to keep in mind, is to audit your suppliers. By doing this, you will know whether, for example, they a complete quality management system (QSR or 13485) and if they have a project management system as well. Remember that as soon as you put your the name of your company on the product, the FDA will assign all responsibility to you and not your supplier. If you want to have the same processes in-house, it is recommended to complete your design control and verify/validate against your FDA approved product made by your supplier. You may find changes that may require filing for a Special or even a traditional 510(k). If your product differs significantly from your supplier, your classification may even change. Long story short (too late?), verify and validate everything against your supplier,especially if you have received FDA approval with their product.

[sanjay_lingot]

is yours third party is FDa approved?

Are you following FDAs standard for design validation?

if yes: collect testing report & submit to FDA.

Or you want to use yours own standards for design validation?

If no then good or its little bit difficult situation.

with kind regards

Sanjay Lingot