FDA approval (Med Device) - Should we use Accredited Person or proceed on Our Own?

S

scr1570

#1
Hi,

We are a small company dedicates to the design of medical device. We are interested in requesting the FDA to be able to sell in US but I have a couple of doubts with regard to the steps to continuing:

1. Our device is a class II is possible to do the application directly to "U.S Food and Drug Administration".

2. What advantages exist to realize it across Accredited Persons as UL beside reducing the time of step.

3. We have seen that realize the request of the FDA across certified persons the cost is 10.000 dollars apx whereas if we will do it directly reduce the cost considerably.

Which is the best way to request the FDA? Could you help me?

Thanks,
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: FDA approval (Med Device) - Should we use Accredited Person or proceed on Our Own

1. Our device is a class II is possible to do the application directly to "U.S Food and Drug Administration".
Yes, you can prepare and submit a Pre-Market Notification, i.e. 510(k) directly to the FDA.

2. What advantages exist to realize it across Accredited Persons as UL
beside reducing the time of step.
The sales pitch of such services usually includes claims that because they have a superior understanding of your product, they can be helpful to you in providing suggestions as to how you most efficiently can structure your application so that they can clear it expeditiously.

3. We have seen that realize the request of the FDA across certified persons the cost is 10.000 dollars apx whereas if we will do it directly reduce the cost considerably.
The APIP program is not widely used. The primary reason for that is that most submitters don't believe such sales pitches are true, and that the greater cost is not justified by whatever benefits might be provided.

If this is your first 510(k), you might want to consider a third path that is much more widely used, and in my opinion much more advisable: enter into a contract with a consultant who is experienced in writing successful Pre-Market Notifications for products like yours, and have that consultant write your first such submission in close consultation with you.

I assume that you could find such a consultant based close enough to you that they could meet with you at your facility and get a first-hand understanding of the issues involved.
 
T

Tim Penrose

#3
Re: FDA approval (Med Device) - Should we use Accredited Person or proceed on Our Own

Excellent advice

We enlisted the help of a consultant based in the US and didn't find the distance particularly burdensome though we did have a few face to face meetings initially.
 
M

MIREGMGR

#4
Re: FDA approval (Med Device) - Should we use Accredited Person or proceed on Our Own

As a side point regarding face to face meetings for such business processes, we are currently finding that low cost two-way video+audio linkages over the internet, accompanied by near-real-time emailing of documents back and forth, are very effective for business interactions at a distance. Other than coordination of the time offset, we find hardly any efficiency loss at all in interacting at a distance now, including split staff meetings between the US and China.

Not every consultant is going to be "up to speed" on such capabilities, of course...but that perhaps is a reasonable selection parameter in such consulting relationships, in that it can considerably decrease project expenses while increasing relationship effectiveness and response speed.
 
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