Class I 510(k) exempt - Applicable Standards

NewRegMan

Starting to get Involved
#1
Hi folks

Just a quick and probably silly question: My product is listed with the FDA as a Class I 510(k) exempt and on the market for many years (unchanged). There is a particular recognized consensous standard with a transition period ending soon! Per FDA the new standard will be required for for new medical equipment and existing equipment requiring FDA re-submission.
What does that mean for my "old" product?
Does re-submission mean the day I pay my registration fees for 2018?
How long can I import my "old" products after the deadline?

Many thanks for a quick reply from the experts.

Cheers:bigwave:
 
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JeantheBigone

Quite Involved in Discussions
#2
Without knowing details, it sounds like you may be in a grey area.

On the one hand, FDA has stated that conformance to a recognized consensus standard is voluntary for non-exempt devices

Voluntary Conformance
Conformance with recognized consensus standards is strictly voluntary for a medical device manufacturer. A manufacturer may choose to conform to applicable recognized standards or may choose to address relevant issues in another manner.
Guidance for Industry and FDA Staff - Recognition and Use of Consensus Standards

On the other hand, in exempting Class II devices, FDA recently stated explicitly that the exemptions are in some cases limited to devices that conform to recognized consensus standards.

Federal Register
::
Medical Devices; Exemptions From Premarket Notification: Class II Devices


I would say that registration is not the same thing as submission, so conformance to the updated standard is likely to be expected once that standard is on the recognized list, and not when establishment registration is up for renewal.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
The above FR notice relates to class II exemptions, so not sure it’s relevant for the OP.

In my understanding “submission” refers to a 510k, meaning that if/when a new 510k is required (eg after a modification that results in a non-exempt device) compliance with the relevant recognized standards will be examined. In my opinion this should not concern the OP, as long as the specific FDA 3-letter product code page doesn’t clearly state that that specific standard compliance is required (i.e. the standard is designated as a Special Control).

In general the FDA does not expect “dynamic” compliance and “keeping up with the state of the art” (like in the EU). Once a device is cleared* it may continue to be distributed in the US indefinitely unless a new ruling is issued or there are serious, specific issues highlighted by the FDA for that specific device or device type.

*) For exempted class I devices, “cleared” normally means that another device with similar characteristics (same classification), that was already in commercial distribution in the USA, was identified, and General Controls have been otherwise complied with in relation to the subject device.
 
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