How to find Certifying Bodies for US based & sold Medical Devices?

[J0anne]

How can I determine the certifying body for a device manufactured and marketed in the US?

 

[GStough]

How can I determine the certifying body for a device manufactured and marketed in the US?

Do you know the manufacturer's name? Sometimes companies post their certs on their websites. If you know, I would start with a Google search for the name of the manufacturer. You could also look at fda.gov/Menu/Medical Devices, scroll down and look for the company or device under the Device Registration and Listing Database link.

 

[GStough]

The FDA search won't yield the certifying body info, but it can narrow down the search for the manufacturer/marketer.

 

[J0anne]

Do you know the manufacturer's name? Sometimes companies post their certs on their websites. If you know, I would start with a Google search for the name of the manufacturer. You could also look at fda.gov/Menu/Medical Devices, scroll down and look for the company or device under the Device Registration and Listing Database link.

Yes I do know the name of the manufacturer and I know I can get a copy of certification if it's available on their website

In the EU it is clear (where possible) from the device itself or on the IFU, should one exist and on the packaging

Is it available on US packaging/device/IFU?

 

[GStough]

Yes I do know the name of the manufacturer and I know I can get a copy of certification if it's available on their website

In the EU it is clear (where possible) from the device itself or on the IFU, should one exist and on the packaging

Is it acceptable on US packaging/device/IFU?

I'll have to defer to someone with more knowledge in packaging to answer that question, I'm afraid. I'm sorry. I do searches all the time for information on suppliers, including certifications, but I wouldn't want to give you incorrect information by guessing.

 

[J0anne]

I'll have to defer to someone with more knowledge in packaging to answer that question, I'm afraid. I'm sorry. I do searches all the time for information on suppliers, including certifications, but I wouldn't want to give you incorrect information by guessing.

Thanks

 

[yodon]

There's no "certification body" in the US. There's no requirement, for example, for a legal (or contract) manufacturer to hold any certifications (e.g., 13485). They do have to register with the FDA.

A product is just cleared by FDA for the market. There are multiple clearance paths, the most typical is a 510(k) which requires that you show substantial equivalence to a predicate device.

You can use this page to search for registered manufacturers and for specific devices (to determine if cleared).

Does that help or did I completely misunderstand?

 

[Sidney Vianna]

In addition to what @yodon mentioned, management system certificates could/should be available via the IAF CertSearch database, but their ineptitude makes that database useless as, for the moment, it is not mandatory, what results in a very high percentage of certificates not being listed there.

 

[GStough]

I thought she meant product certification.. So sorry... I'll find my way out now....

 

[Sidney Vianna]

I thought she meant product certification..

The op is unclear, and my semieducated guess was for system certification, since AFAIK, differently than the european CE-Mark scheme, in the USA, medical devices do not get certified per se but, and instead, FDA approved.