Regulatory Open Forum

Any advice from you will be very helpful for us.
We sell class I medical devices, and we have been requesting customers to fill out a form of a sort of "a letter of intent to purchase the device (as an RUO or as a Medical Device)".  Is this a part of FDA regulatory requirements, or this is for our internal use only?  If this a part of requirement for the medical device manufactures, where can I find the requirement?

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Izumi Clifford PHD
Regulatory and Quality
Columbia MD
United States
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Izmui,

Mainly it is part of a firm's CYA approach.  

CYA: Cover Your Analysis not A***

Basically we can't crawl into a firm's mind/business practice.  To cover your analysis/practice when you are selling your products, for example, if you label a reagent for RUO, you are supposed to sell yours for RUO purposes not for clinical purposes.

But when a firm knows its potential client intends to use the reagent as a medical device (e.g., IVD), a firm must decide not to sell it although in real practice, firms still sell. 

The letter of intent is to understand the intended use by your prospective clients. 


Original Message:
Sent: 01-29-2015 14:36
From: Izumi Ishii-Clifford
Subject: Is a letter of intent required from a class I medical device purchaser (customers)?

Any advice from you will be very helpful for us.
We sell class I medical devices, and we have been requesting customers to fill out a form of a sort of "a letter of intent to purchase the device (as an RUO or as a Medical Device)".  Is this a part of FDA regulatory requirements, or this is for our internal use only?  If this a part of requirement for the medical device manufactures, where can I find the requirement?

-------------------------------------------
Izumi Clifford PHD
Regulatory and Quality
Columbia MD
United States
-------------------------------------------

You need to be very clear about your intention and make a sharp distinction between a product that is a Class I medical device and a product that is an RUO.

 

A product that is a medical device is manufactured in a QSR complaint facility and may be used for diagnostic purposes. It should be labeled "For in vitro diagnostic use". An RUO does not have to be manufactured in a QSR compliant facility and may not be used for diagnostic purposes. It should be labeled "For Research Use Only".

 

An RUO is, 809.10(c)(2)(i), a "product in the laboratory research phase of development, and not represented as an effective in vitro diagnostic product".

 

You should read the guidance document "Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only", UCM376118. It has a section on certification programs and says, "User certification programs, where users certify that they will not use RUO/IUO products in a manner inconsistent with the labeling, would be viewed as one factor to consider ... "

 

You don't need a certification program for a Class I medical device, since it may be used for diagnostic purposes. A certification program for RUOs is one element in assuring that your distribution activities are consistent with the RUO status.

 

I recommend that you carefully review all of your RUO labeling and distribution practices against the regulations in Part 809 and the recommendations in the Guidance Document.

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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 01-29-2015 14:36
From: Izumi Ishii-Clifford
Subject: Is a letter of intent required from a class I medical device purchaser (customers)?

Any advice from you will be very helpful for us.
We sell class I medical devices, and we have been requesting customers to fill out a form of a sort of "a letter of intent to purchase the device (as an RUO or as a Medical Device)".  Is this a part of FDA regulatory requirements, or this is for our internal use only?  If this a part of requirement for the medical device manufactures, where can I find the requirement?

-------------------------------------------
Izumi Clifford PHD
Regulatory and Quality
Columbia MD
United States
-------------------------------------------

Thank you all for your advice and the reference.

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Izumi