FDA class 1

Noha Ahmed

Starting to get Involved
#1
What are the requirements to obtain FDA certificate class 1 ? What are requirements for self declaration ? how can i get the approval ?
 
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GStough

Leader
Super Moderator
#2
What are the requirements to obtain FDA certificate class 1 ? What are requirements for self declaration ? how can i get the approval ?
Are you referring to medical devices, food, cosmetics, or pharmaceuticals? What are you trying to self-declare? Some more details would be helpful to get the information you're seeking. :)
 

Ronen E

Problem Solver
Moderator
#5
What are the requirements to obtain FDA certificate class 1 ? What are requirements for self declaration ? how can i get the approval ?
For exempt* class 1 devices there is no obtainable "FDA certificate".
There is also no "self declaration" (officially, there is no "declaration" at all).
And there is no "approval" as well (in fact, you are not allowed to say things like "FDA approved", even if your device is in full compliance).

For class 1 you need to comply with the "General Controls", which include (among other things) Establishment Registration (for the company, just once) and Device Listing (for each device model). You can find the details through the link @chris1price noted.

_________________
*) Most class 1 devices are exempt from Premarket Notification ("510(k)" / Part 807), which is the closest to an "FDA certificate" as it gets, for lower classes devices (i.e. devices not in class 3, which can actually get an Approval - PMA). To ensure that your device type is indeed exempt, you need to first determine its ProCode (a three letter code representing the device type or family). The way to do that is through identifying a similar device (same intended use and technological characteristics) - preferably a class 1 device - that is already legally distributed in the USA and does not have any outstanding safety issues (or other issues) preventing it from continuing to be legally distributed. Once such a device is found, look up its Device Listing in the FDA database, and note its ProCode (that will be your device's ProCode as well). Then you'd be able to look up that ProCode in the FDA classification database, and see what the requirements for it are. Most likely, if it's a class 1 device, it will only be the General Controls, and no 510(k) - an exempt classification. But you have to verify it, because if the ProCode says a 510(k) *is* required, and you can't find a suitable ProCode that is 510(k) exempt, you'd have to submit one and receive a "Substantially Equivalent" determination (again, it's not a "certification" or an "approval") from the FDA before you commence distribution in the USA.
 

mihzago

Trusted Information Resource
#6
And there is no "approval" as well (in fact, you are not allowed to say things like "FDA approved", even if your device is in full compliance).
Actually, you can use "FDA Approved", but only for approved PMA (Pre Market Approval) submissions.
 

Ronen E

Problem Solver
Moderator
#7
Actually, you can use "FDA Approved", but only for approved PMA (Pre Market Approval) submissions.
...which, if granted, would be granted to a class 3 device.
My entire post (quoted from) is in the context of class 1, and the "And" in the quote above connects it to the sentence two lines above it, beginning with "For exempt class 1..."

Anyway, it's true that one can use "FDA approved" for a device with an approved PMA.
 
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