What are the regulatory requirements to sell a Class II Medical Device in USA?

[Jojo63]

Hello,

What are the regulatory requirement to sell a MD class II in USA?

It must be approved 510k, but the production facilities must be GMP certified? We are already certified ISO 13485.

Thank you.

 

[ScottK]

Here are the basics:
https://www.fda.gov/MedicalDevices/...HowtoMarketYourDevice/RegistrationandListing/

Go down the table on the left side of the page for more specifics as to how to register, how to list, acquiring a US agent, etc.

 

[Jojo63]

Thank you for your reply but we are yet to record.

Except for the representative, I want to know if our current organization allows us to sell in the US. If our MD 510k and we are certified ISO 13485, is this enough? Or, in addition, our facilities must be GMP certified?

 

[MIREGMGR]

There is no such thing as "facility GMP certification" for FDA Class II devices. Various rules exist; some of those are called the "GMPs". You are required to conform, and in the case of a 510(k)ed device to declare that conformance, but not otherwise required to prove that conformance, prior to initiating marketing.

Whoever prepared and filed your 510(k) must already have known this answer. Consult with that person, as there are many other things of which to be aware.

 

[Jojo63]

Also, we are certified ISO 15378 (Primary packaging materials for medicinal products ? Particular requirements
for the application of ISO 9001:2008, with reference to Good Manufacturing
Practice (GMP)).

Thank you.

 

[MIREGMGR]

FYI, ISO 15378 is specific to pharmaceutical GMPs, not medical device GMPs. Different sets of rules/expectations.

Also, US FDA does not use or recognize ISO 15378. That standard is not found by a search on either the pharma or device FDA sites. The GMPs to which that standard is targeted are the EU pharma rules, which are independent of US FDA's pharma rules.

 

[Ronen E]

A class II device manufacturer must comply with the General Controls (unless the device is explicitly exempted), and additionally must address all requirements listed under the relevant 3-letter code. The code is the one designated in the 510k (normally it's the same as the predicate's code). Search the FDA website for the specific code page, to find the specific requirements, exemptions and guidance (Special Controls).

Cheers,
Ronen.

 

[Jojo63]

Thank you for your reply.