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IEC 62304 compliance status - Is it mandatory for 510(k) submittal?

W

whyme

#1
Hello all,

Well, I have searched and searched this forum, the FDA and Europa websites and cannot a get a definitive call on whether the 62304 standard is effectively 'mandatory' for medical device manufacturers submitting 510Ks, maintaining compliance to GMP/ISO 13485, and developing products for CE-Mark.

I noticed that the FDA have listed this standard in their consensus standards as of 31 July 2008. Our company does have plans to implement this standard in the next 12 months, I just don't want to get a nasty suprise for any 510ks we submit before then or in our next Notitfied Body audit.

Thanks in advance...
 
D

danpa

#2
Re: IEC 62304 compliance status

My understanding is that 62304 is not mandatory for 510(k) submittal. We recently completed a 510(k) without any 62304 conformance statement.
I remember that there has been talk that the FDA was looking into allowing conformance with 62304 to reduce the amount of 510(k) work and review time, but I don't believe this has been implemented.
 
M

MIREGMGR

#3
Re: IEC 62304 compliance status

No consensus standard is mandatory at this time, at least in regard to 510(k)s.

Quoting from http://www.fda.gov/cdrh/osel/guidance/321.html, "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."

Two ways to structure a premarket notification application are by showing compliance with FDA-specified consensus standards, or by showing substantial equivalence to a legally marketed predicate device.
 
W

whyme

#4
Re: IEC 62304 compliance status

My understanding is that 62304 is not mandatory for 510(k) submittal. We recently completed a 510(k) without any 62304 conformance statement.
I remember that there has been talk that the FDA was looking into allowing conformance with 62304 to reduce the amount of 510(k) work and review time, but I don't believe this has been implemented.
Thanks danpa and MIREGMGR for your responses on the FDA side of things. I accept that consensus standards are never mandatory, though you often need a good reason why you have not followed one (if it exists). I think software will be a special case because there are a number of established FDA guideline documents for s/w, none of these at the moment mention 62304. So I am comfortable enough for now with 510k submissions.

I was wondering if anyone in the forum can shed any light on potentially when the IEC/EN 62304 standard may become harmonized under the MDD. Is it currently being considered? How long would they normally give manufactuers to implement this standard if it did become harmonized? I was a little concerned when one forum member wrote they were already asked by their Notified Body to show conformity to this standard.

Again, as has been stated many time before, harmonized standards are but one way of meeting MDD Essential Requirements, but they sure can make life easier when dealing with Notified Bodies and de-risking your projects.:D
 
M

Micked

#5
I have one good reason for recommending my client to follow 62304.
It is a European manufacturer aiming for the CE mark, but they also have to file a 510(k) in due time.
If they can show that they are compliant with 62304, there is no need to follow all the FDA software guidances.
On top of that I think that 62304 has a very good way of handling SOUP, I don't think that is crystal clear in the various FDA guidances.

The bottomline = make it simple for yourself!
 
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