Updating a Medical Device's Intended Use

P

PL.

#1
#1
Hi there,

We are stuck in some kind of dilemma...

Background
We apply a 510k for nebulizer a year ago (which is cleared a half year ago), and we submitted our intended use according to a predicate device dated in 2007.

Similarly with the predicate, we state in intended use that the device is not for xxx (a drug) use.

But, we find out that other similar devices cleared these two years do not have that restriction (not for XXX use).

Question
We would like to remove the restriction in intended use...should we submit a new 510k?
 
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Ronen E

Ronen E

Problem Solver
Moderator
#2
#2
PL. said:
Hi there,

We are stuck in some kind of dilemma...

Background
We apply a 510k for nebulizer a year ago (which is cleared a half year ago), and we submitted our intended use according to a predicate device dated in 2007.

Similarly with the predicate, we state in intended use that the device is not for xxx (a drug) use.

But, we find out that other similar devices cleared these two years do not have that restriction (not for XXX use).

Question
We would like to remove the restriction in intended use...should we submit a new 510k?
Click to expand...
Probably yes.

http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/ucm080243.pdf
 
mihzago

mihzago

Trusted Information Resource
#3
#3
not enough information in the description, but in general removing restriction typically goes with expanding the indications for use (e.g. expanded patient population), which usually requires a new submission.
 
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