How to get an FDA approval before May 2010 - ?Quick and Dirty? FDA Approval

L

Leifi

How to get an FDA approval before May 2010 - “Quick and Dirty” FDA Approval

I am a technical manager at a small European company.

We are making an accessory to a Medical Device which is FDA approved. Our accessory is comprised of a digital camera (FDA approved), lens adapter (made at an ISO 9001 certified company in the US), an simple electronic circuit (made at a ISO 9001 certified company in China) that receives signal from the Medical Device and triggers the digital camera, and software made by us (not an ISO certified company). The Medical Device has not been changed in any way (there is a mounting bracket on top of it to attach our accessory there).

The instrument captures, records and displays images which can be used by medical professionals to assess patients’ conditions and follow treatment evolution. The software stores the relevant patients’ medical data and associated images in its database.

Does anyone know if and how FDA approval can be attained before May 2010? We are planning to attend a scientific exhibition conference with our device. What can we do to establish a good route for this?

Is it possible to import the device to the USA and use it for research purposes before it gets the FDA approval?

What are the requirements for software? Does our software need any specific inspection?!

Best thanks,
Thorleifur
 
Marc

Marc

Fully vaccinated are you?
Leader
Re: How to get a FDA approval before May 2010 / “Quick and dirty” FDA approval

Any advice from the Medical Device experts here?
 
Q

Qara123

Involved In Discussions
Re: How to get a FDA approval before May 2010 / “Quick and dirty” FDA approval

Leifi said:
Does anyone know if and how FDA approval can be attained before May 2010? We are planning to attend a scientific exhibition conference with our device. What can we do to establish a good route for this?
Click to expand...


Hi Leifi,

I doubt you (or anyone else for that matter) will be able to prepare, submit, and obtain approval for your medical device in 5 months, especially if you are unfamiliar with the application process.


Is it possible to import the device to the USA and use it for research purposes before it gets the FDA approval?
Click to expand...
It depends on what you mean by research. If you are sending the device to a test lab for analysis, that would not be under FDA's jurisdiction. If you are performing tests on humans, you will need an approved IDE but this is usually to commence clinical trials (an IDE approval will take at least 90 days).

What are the requirements for software? Does our software need any specific inspection?!
Click to expand...
FDA requires software to be validated, see 21 CFR part 11.
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm


It appears your goal is to present your medical device at the May 2010 conference and not the FDA approval itself. The easiest way may be to conduct the test outside the USA and present your results at the conference.

Q
 
M

MIREGMGR

Re: How to get a FDA approval before May 2010 / “Quick and dirty” FDA approval

What is the Product Family and Class of the system with which the camera subsystem will be used? Is the higher level system yours?

FDA classification is always an important issue, and is subject of course to the FDA's sometimes hard-to-follow logic. Do you expect that the camera subsystem most likely will be classified into the same Product Family and thus Class as the higher level system, or will it fit into a separately defined Product Family, perhaps in a lower Class?

If the higher level system is yours and a Class II device and the current task is to add an accessory, and if the functionality of the lens adapter, triggering circuit and control software plus the camera is such as to present a negligible degree of additional risk in regard to the safety and effectiveness of the higher level system, and if you can appropriately show that via design controls, then you might be able to follow the Special 510(k) route.

In theory, it would be possible to prepare, file and receive clearance for a Special 510(k) before your deadline.

In theory, it would be possible to prepare, file and receive clearance for a Traditional 510(k) before that deadline instead, but due to the longer review plus the higher "bar to clear" if a traditional is required, that seems unlikely.

In practice, of course, it would be prudent to follow Qara123's advice in parallel with whatever effort is made toward the clearance.

Obviously, if the higher level system is Class III, you can forget about getting anything cleared for it before next May, except possibly an IDE.
 
L

Leifi

Re: How to get a FDA approval before May 2010 / “Quick and dirty” FDA approval

[FONT=&quot]Thank you all very much for sharing your experience with us and giving us that useful advice!

We realize that it will be quite a challenge to get a FDA approval for May 2010 since we are not familiar with the American regulations and the process by itself.

Our device is an accessory to a Class II device. It also falls into Class I 510(k) exempted classifications. The whole system is substantially equivalent to other devices which already have 510((k) Premarket Approvals.

We are actually dealing with two problems:

- The first thing is that we were planning to have a booth at this conference/tradeshow in May 2010 and to bring and show our device there.
Are we allowed to do it without any clearance?[/FONT]
[FONT=&quot]If yes, and if someone is interested in the device and wants to buy it, we could we apply for an IDE and have them as sponsors for instance?[/FONT]
[FONT=&quot]- An American University is now highly interested in our device. They would like to use it for their research protocols, which involve patients.
As far as we understood, IDEs are only meant to prove that a medical device is safe and effective. So that would mean that that research institute would only be able to use our device to collect data for us. Did we get that right?
We also read that 510(k) submissions do not always require an IDE. How do you know then when your submission requires one or not?
Since we are a foreign manufacturer we also have to designate a sponsor in the States. Can that University be our sponsor or should we designate someone else in the State (or outside State)?[/FONT][FONT=&quot][/FONT]
 
M

MIREGMGR

Re: How to get a FDA approval before May 2010 / “Quick and dirty” FDA approval

My analysis is that you are getting into shaky marketing territory, particularly given the nature of your in-house expertise as evidenced by your questions, and you may need to engage a consultant with suitable expertise and credentials rather than relying on this thread as support for a strategic business course.

Leifi said:
[FONT=&quot]- The first thing is that we were planning to have a booth at this conference/tradeshow in May 2010 and to bring and show our device there. [/FONT][FONT=&quot]Are we allowed to do it without any clearance?
Click to expand...
[/FONT]

Assuming that this tradeshow is within the US:

Not without making it clear that the device is not approved and is not for sale or for use on patients.

...[FONT=&quot]if someone is interested in the device and wants to buy it, we could we apply for an IDE and have them as sponsors for instance?
Click to expand...
[/FONT]

My understanding is that the FDA attempts whenever possible to keep the IDE system from being used as a way around the device approval system and the prohibition on sales of unapproved devices. However, someone with more legal expertise might have a more nuanced perspective.

[FONT=&quot]
- An American University is now highly interested in our device. They would like to use it for their research protocols, which involve patients. [/FONT]
Click to expand...
[FONT=&quot]As far as we understood, IDEs are only meant to prove that a medical device is safe and effective. So that would mean that that research institute would only be able to use our device to collect data for us. Did we get that right?
Click to expand...
[/FONT]

There are a number of "ifs" and assumptions there, regarding obtaining the relevant IDE in the first place. I'm doubtful that this approach is viable for you; however, my expertise is insufficient in this area.

[FONT=&quot]
We also read that 510(k) submissions do not always require an IDE. How do you know then when your submission requires one or not?
Click to expand...
[/FONT]

It is most common in current 510(k) clearance to base a claim of substantial equivalence on physical and functional similarity to one or more existing devices that either have received approval or have "pre-approval" status, i.e. were marketed before the current approval rules were adopted in 1976.

A device that is novel, i.e. cannot show substantial equivalence to prior devices per the above, may be Class III rather than Class II. However, the FDA's classification system is a mess, and questions in this area often cannot be answered with certainty without getting the FDA to make an on-the-record determination.

You stated "Our device is an accessory to a Class II device. It also falls into Class I 510(k) exempted classifications. The whole system is substantially equivalent to other devices which already have 510((k) Premarket Approvals." If this is already determined with sufficient and non-challengeable certainty, and if the device will be classified as Class II, there would be no point to an IDE since clinical data would not be needed to establish its approvability. (In theory, unless the FDA chose to see things differently.) The FDA is unlikely to grant an IDE unless it agrees that there is a legitimate purpose for it.
 
Michael Malis

Michael Malis

Quite Involved in Discussions
Re: How to get a FDA approval before May 2010 / “Quick and dirty” FDA approval

Hi,

Based on my understanding of your device and my 25 + years of exp., you are not getting a 510(k) clearance before May 2010.

However, you do not need to have a 510(k) clearance for this device in order to show it at the show/conference. You MUST clearly mark this device and all Literature as "pending 510(k) clearance" (assuming that you will apply for it).

You have a lot of missing information in order for me even try to classify this device:
1. What are your claims?
2. Intended Use of this device?
3. What is the difference between what was approved and what you have? 4. Do you need any Clinicals for this 510(k), based on your claims?
If the answer is yes, - it may take years in present FDA environment to get information for 510(k) submission)

Please clarify,
Mike
:evidence:
 
L

Leifi

Re: How to get a FDA approval before May 2010 / “Quick and dirty” FDA approval

Hi all and thanks for the replies!

Ok for the conference: It seems that we don’t need any clearance to exhibit there.We mark the instrument and all our literature as “pending 510(k) clearance”.
Combined with the main medical device (which is a FDA class II device), our equipment (hardware+software) captures, stores and displays images, and calculates physiological parameters from those images. So far we have been acquiring data from patients (in Europe) to establish that the instrument and software are actually doing what they are intended to do. The results are promising and show that the instrument+software can help in the study of diseases.

 At the conference we will have a lecture and posters with the results from our instrument. We will also have the instrument+software on display (again, marked as “pending 510(k) clearance”).

 For further development we would like to get more involved in clinical testing and have been looking for institutes which are willing to gather further data from patients in the US and Europe.
We would like to send/sell the instrument to research institutions (hospitals) in the US and Europe for more research/investigations. In order to do that, will the US institutions in question have to apply for some research/investigational exception from the FDA?

According to: Displaying Investigational and Unapproved Medical Devices According to FDA Policy

Although a firm may advertise or display a device that is the subject of a pending 510(k)*in the hope that FDA will conclude that the device is substantially equivalent to a preamendment device*a firm may not take orders or be prepared to take orders that might result in contracts for sale for the device unless limited to research or investigational use.
Click to expand...
Thanks,
Leifi
 
M

MIREGMGR

Re: How to get a FDA approval before May 2010 / “Quick and dirty” FDA approval

Leifi said:
It seems that we don’t need any clearance to exhibit there.We mark the instrument and all our literature as “pending 510(k) clearance”.
Click to expand...


This is correct if your 510(k) has already been submitted to FDA ("is pending").

I don't know about the event you will be attending, but (for instance) it's well known that the FDA sends investigators to the RSNA (a major medical show for imaging technologies) to note what new equipment is displayed and what disclaimers are stated regarding marketing, then to review that equipment against the FDA database of pending 510(k) applications. I assume that a similar approach is used on some occasions at other shows.

We would like to send/sell the instrument to research institutions (hospitals) in the US and Europe for more research/investigations. In order to do that, will the US institutions in question have to apply for some research/investigational exception from the FDA?
Click to expand...
It is irregular to use an IDE approach for a Class II device, unless the FDA has requested additional data to support the substantial equivalence claim of an already-filed traditional 510(k) application or the data is needed for the preparation of the standards-compliance claim of an abbreviated 510(k).
 
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