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Question re: Class II 510K Enforcement Discretion

A

AJayC

#1
#1
I have a question regarding a medical device accessory that would be classified as "Class II 510k with enforcement discretion"?

Would that mean a 510k is not required for that medical device?
 
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A

AJayC

#3
#3
Under the Product code it states that Submission Type is "Enforcement Discretion".

I just found this guidance for FDA Staff on the enforcement policy

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm283904.htm
Refer to the section on In Vitro Diagnostic and Radiology Devices For Which FDA Intends to Exercise Enforcement Discretion With Regard to Premarket Notification Requirements.

The guidance then references several CFRs regarding the 510K exemptions.
Below is the link for 21 CFR 892.9 regarding Radiology Devices:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=892.9

It appears to define "enforcement discretion" as being exempt from the 510K submission process.

quote: ...exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or...

FDA also lists several reasons why a device would not be exempt, such as the device having a different intended use.

So I guess I have answered my own question :>
 
Last edited by a moderator:
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#4
#4
Hi,

To answer your original question: it seems that a 510k will not be required as long as your device has a predicate, of the same classification, already legally on the market. I strongly recommend you hold a detailed documentation explaining how/why your device and the predicate have the same intended use and the same fundamental scientific technology.

Cheers,
Ronen.
 
M

maryloup

#5
#5
Dear All, So it means the company has only to register & list their devices and have GMP put in place if required ? and then can put MD on the US market ?
 
M

MIREGMGR

#6
#6
Yes, but be sure to study the applicable guidance as noted above, and memo-to-file how your particular product conforms to the applicable requirements.
 
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