Home Based Medical Device Manufacturers or Component Vendors (Suppliers)?

A

aoldendo

#1
Hi everyone,

This may be a mundane question..

What is the FDA's stance on home-based manufacturers of medical devices or home-based vendors who supply components to be used in the medical devices? Is this something the FDA allows?

Is there any part of the Code of Federal Regulations which addresses such companies?

Thanks,
A
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Hi everyone,

This may be a mundane question..

What is the FDA's stance on home-based manufacturers of medical devices or home-based vendors who supply components to be used in the medical devices? Is this something the FDA allows?

Is there any part of the Code of Federal Regulations which addresses such companies?

Thanks,
A
Any FDA Regulation experts who can comment on this?

Thank you!

Stijloor.
 
M

MIREGMGR

#3
"Home-based" is an irrelevant distinction to any medical device regulatory body that I know of. If you manufacturer medical devices, you're a medical device manufacturer. There's only one set of rules and expectations, whether you're large or small.

A medical device maker buying components from a small supplier would be expected to maintain the same level of control over their actions and products as would be maintained for a large supplier.

Practically speaking, that might make it difficult for the very small supplier to exist, because the overhead of the regulatory effort would be too great. From a regulatory perspective, this is an unfortunate but justified consequence of the overriding need for medical devices to be safe and effective.

The same conflict between company size and the workload imposed just to be compliant and be able to prove it, exists in the food industry to a considerable extent and also of course in the pharma industry.
 
Last edited by a moderator:
W

WalkingSeed

#4
I have to agree with MIREGMGR. The FDA does not distinguish between the size of the business in the law. Have you browsed the FDA's web site., http://www.fda.gov/MedicalDevices/default.htm? The specific CFR is 21 CFR 820, ISO-13485 and ISO/TR14969 for additional information.

Your best bet if you have something that you think is marketable is probably to patent it and sell that to a major manufacturer or locate a medical device incubator / technology development operation associated with a major university in your area and see if they have interest to work with you to bring it to market.
 
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