Dawn,
You got great information from others. Here is some additional info for your consideration.
1. During device development,
consider all the key (fundamental) questions and come up with "Intended Use and User Needs." Simply speaking, WHAT IS IT FOR?
2. Then determine if it is a medical device, IVD?
3. If IVD, determine whether it is a research use only (RUO), ASRs, screening, or monitoring or DIAGNOSTIC, or staged in development?
4. Identify the relevant and applicable regulation(s), if any.
5. Identify the relevant and applicable Product Code ("Pro Code"), if any.
6. Based on your intended use, look for a predicate(s) available.
Please note: it is possible that a device may not be classified ("unclassified") and it is also possible that there is no pro code available, which means there is no predicate available.
7. IDE/510(k)/PMA/De Novo/CLIA are all applicable to IVD products.
8. Regarding IDE/PMA for IVDs, please refer to the recent
Guidance document, dated July 3, 2012.
9. What if it is a combination product (for example,
Duke University's Prospective Study), then it gets re-routed to another center as the lead center.
Please note the statements in the letter "We have determined that if CDRH had the lead in reviewing your proposed clinical
investigation, it would represent a significant risk study in accordance with the definition for a
significant risk device in section 812.3(m) of the investigational device exemptions (IDE)
regulation...." [Relevant part omitted].
10. Recommendation/Suggestion: When you have your Intended Use, device classification, product code, predicate device(s), device description (including components and accessories), your plan of clinical study including your protocol including statistical justification and patient populations (if available) or ANY COMBINATION THEREOF, you summarize your plan in 10-20 pages or so and submit it as a "Pre-IDE" to get the Agency's comments - FREE and usually 20-60 days of time window.
CAUTION: If device classification inquiry is made to agency under 513(g), fee applies.
PLEASE (try to) use CLSI standards, which are helpful for demonstrating performance characteristics/studies (e.g., sensitivity, specificity, reproducibility, cut-off, limit of detection, etc.). FDA recognizes over 100 CLSI standards.
When you write your Pre-IDE document, your tone should be "this is our (detailed) proposed plan for carrying out performance studies and clinical studies." We believe our proposed plan would meet the requirements and the Agency's expectation. Thus, we respectfully request the Agency provide comments to our proposed plan. In other words, you are seeking the Agency's comments not asking the Agency to propose your study.
In fact, Agency's comments are mostly predictable, but sometime, it is out of the question, especially when both parties (firm and the Agency) are learning the technology. In a way, the pre-IDE submission could also serve as a way to initiate a dialogue concerning your device and technology.
There are many things to consider and thus, the approach needs to be adjusted on a case by case basis. But what I provide here may help you to get the ball rolling.
-------------------------------------------
Regulatory Doctor and Coach www.GlobalComplianceSeminar.Com Riner VA
United States
-------------------------------------------
Original Message:
Sent: 08-13-2012 10:13
From: Sarah Parsons
Subject: Questions regarding IVD FDA submission
Dear Dawn,
An IDE is required if there is significant risk to the patient (invasive sampling). There is guidance on the FDA web site: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf
Look to the 21CFR 812 for IDE requirements.
If there is no product code for the device, it will be classed as Class III. I highly recommend that you send in a pre-IDE to describe the IVD and have some specific questions answered.
To look for a predicate, you can enlist marketing to identify what the competators have. There is also great information on Device Advice: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134571.htm
I'm not sure if there is any specific PMA guidance that focuses on IVDs, but here is another link: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm050490.htm
If you wish to contact me for additional questions I am happy to help.
-------------------------------------------
Sarah Parsons RAC
Associate Director Regulatory Affairs
Janssen Diagnostics
Rochester NY
United States
-------------------------------------------
Original Message:
Sent: 08-12-2012 01:46
From: Dawn Chang
Subject: Questions regarding IVD FDA submission
I have a few questions regarding FDA IVD submission:
1. Does FDA require IDE study to support an IVD 510(k)? If FDA does, what is the requirement for the IDE study? Is there any guidance document to that regard?
2. Is it possible that there is no product code exist for a particular IVD product? In this circumstance, is there a process to apply for a new product code with FDA? Is there any guidance document to that regard?
3. How does one usually identify a predicate device for an IVD product?
4. Is there an FDA guidance document specific for IVD PMA?
Thank you.
-------------------------------------------
Dawn Chang RAC
Mountain View CA
United States
-------------------------------------------