We are considering development of a new subsystem for FDA approved medical device (Not manufactured by us). Could we get an FDA approval independently or do we need to make contact with one of the manufacturers first.

We are considering development of a new subsystem for FDA approved medical device (Not manufactured by us). Could we get an FDA approval independently or do we need to make contact with one of the manufacturers first. I believe the manufacturer of the finished device will get FDA approval. If the subsystem can be sold as an accessory or by itself and you sell it with your name on it, you will need FDA approval, otherwise you will have the Quality requirements flowed down from the device mfr.

I believe the manufacturer of the finished device will get FDA approval. If the subsystem can be sold as an accessory or by itself and you sell it with your name on it, you will need FDA approval, otherwise you will have the Qyuality requirements flowed down from the device mfr.

Thanks for your reply.
The subsystem can not be sold by itself to the end user. In this case, does every manufacturer have to get separate approval for adding our subsystem? Could we buy systems in the free market, add our subsystem and make all the preclinical and clinical studies needed for FDA approval by ourselves?
Thanks in advance for replies,
Stein al

Thanks for your reply.
The subsystem can not be sold by itself to the end user. In this case, does every manufacturer have to get separate approval for adding our subsystem? Probably. We are discussing a hypothetical situation, so I cannot be asolutely certain without knowing the specifics. I would not ask you to reveal the details since they are probably proprietary. You haven't mentioned the classification.

You might look here for more information as to whether a 510(k) is required http://www.fda.gov/cdrh/devadvice/314.html
or here for a PMA http://www.fda.gov/cdrh/devadvice/pma/


Could we buy systems in the free market, add our subsystem and make all the preclinical and clinical studies needed for FDA approval by ourselves? Again It depends. In addition to the regulatory issues, there are probably commercial issues like licensing due to patents.

Stein al,

After I previously posted, I came across this article that you may find useful.

http://www.devicelink.com/mddi/archive/04/07/015.html

Stein al,

After I previously posted, I came across this article that you may find useful.

http://www.devicelink.com/mddi/archive/04/07/015.html

Thanks Al Rosen,
This article is useful in aspects of private labeling.
Anyhow, it seems that there are no clear answers to our questions.
Thanks again,
Stein al

All medical device manufacturers (including specification developers), repackers/relabelers, initial importers, and foreign manufacturers and exporters have to register plus list their medical products with the FDA.

FDA is interested in two types of medical device products:
a. Finished products.
b. Components/ accessories which are ready to be used for any intended health related purpose and are packaged or labeled for commercial distribution for such health-related purpose.

However, not all registered companies own the products or need approval by FDA to market the product.

Medical device products are either grandfathered, need to show substantial equivalence to products marketed prior to May 28, 1976, or need to show they are safe and effective.

For the US market, FDA has three types of product classifications. These classifications are based upon risk.

1. Class I (§ 513)

These are low risk medical devices which undergo general controls
(GMP’s).

For example: Crutches, bandages, first aid kits.

2. Class II (§ 514)

These medical devices have insufficient information to be class I devices
and need to undergo additional constraints (i.e. special controls,
performance standards, post market, surveillance, guidelines, patient
registries) besides the general controls (GMP’s).

For example: Burn dressings, daily-wear contact lenses, orthopedic
implants.

3. Class III (§ 515)

These medical devices have insufficient information for special controls
to be class II products, can not be classified into class I or class II
devices and are typically life-sustaining/life supporting products. These
products either need premarket approval or have 510(k) classification.

For example: Extended-wear contact lenses, pacemakers, orthopedic
cement.

As such:
1. Is the product a finished medical device?
2. Is the product a 510(k) product (i.e. substantially equivalent) or a 510(k) exempt product? If not, then the product is a PMA product (i.e. need to show safety and effectiveness)?

If there are changes to the product design (which include changes to intended uses and product labeling), these changes have to be evaluated to determine whether a new 510(k) or PMA supplement needs to be submitted to the FDA.

If company "X" owns the product and company "Y" distributes the product, then company "Y" does not need to submit a 510(k) or PMA. However, if company "Y" changes the intended use, design, packaging, labeling (other than re-stickering with company name, address, and telephone), then company "Y" now owns this revised device and needs to submit a 510(k) or PMA.

Thanks and welcome to the Cove :bigwave:

Btw, I have this to the FDA section; its right abode ;)