Laboratory Use Only Software: What does this imply?

P

Paperman

#1
We are a Dutch IVD production company, and one of our products is an HLA-typing software package that is sold as CE-marked IVD-accessory in Europe.
Products that we sell outside Europe are marked RUO (Research Use Only).
We are currently in exploring possibilities for the sales/ distribution of this software package in the US. A possible distribution candidate told us that they are not allowed to sell software as RUO but only as LUO: Laboratory Use Only.
This raised the following questions within our company:

  1. What are the reasons for this explicit distinction?
  2. What are the differences between LUO and RUO?
  3. What are the implications for us as manufacturer?
  4. What must we do in order for us to comply with this requirement?
Thank you very much in advance for your help.

Kind regards.
 
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Mikishots

Trusted Information Resource
#3
We are a Dutch IVD production company, and one of our products is an HLA-typing software package that is sold as CE-marked IVD-accessory in Europe.
Products that we sell outside Europe are marked RUO (Research Use Only).
We are currently in exploring possibilities for the sales/ distribution of this software package in the US. A possible distribution candidate told us that they are not allowed to sell software as RUO but only as LUO: Laboratory Use Only.
This raised the following questions within our company:

  1. What are the reasons for this explicit distinction?
  2. What are the differences between LUO and RUO?
  3. What are the implications for us as manufacturer?
  4. What must we do in order for us to comply with this requirement?
Thank you very much in advance for your help.

Kind regards.
In the eyes of the FDA, RUO items are unregulated; they are not to be used to diagnose, and they can be sold without any FDA clearance or approval.

Many companies sell devices as RUO and then go on to advertise their use in clinical settings; if the FDA gets wind of this, they can intervene and have the RUO designation stripped from that device.
 

v9991

Trusted Information Resource
#4
while the experts join in with specific insights...
here's few points...
RUO as per US FDA... PART 809 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE is used in following circumstances.
"(i) For a product in the laboratory research phase of development, and not represented as an effective in vitro diagnostic product, all labeling bears the statement, prominently placed: "For Research Use Only. Not for use in diagnostic procedures.""
where as EMEA provides following interpretation...“RUO” Labelled Products and the IVD Directive 98/79/EC
Directive to “research use only” products as follows:
“whereas instruments, apparatus, appliances materials or other articles, including the software which are intended to be used for research purposes, without any medical objective are not regarded as devices for performance evaluation”.
however, following USFDA FAQ section does allow s/w to be marketed under RUO
Draft Guidance for Industry and FDA Staff - Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions
7. Is it appropriate for a manufacturer or distributor to market software labeled RUO or IUO?
Yes, software that is a stand-alone IVD product, or a component of or an accessory to another IVD product, which is labeled in accordance with 21 CFR 809.10(c)(2), may be marketed for research or investigational use to entities conducting research or investigations with the software. Such software is subject to the same limitations on promotion and marketing as other IVD products labeled RUO or IUO.
8. Should the manufacturer of an IVD product labeled RUO or IUO help with the validation and verification of performance specifications of an LDT or other test that the manufacturer knows is used in clinical diagnosis that utilizes its product?
No. If the manufacturer of an IVD product labeled RUO were to assist in the validation or verification of the performance of a test that the manufacturer knows is used in clinical diagnosis using its RUO-labeled IVD product, FDA would consider such assistance to be evidence of non-research intended use. As explained above, this may render the device misbranded under sections 502(a) and 502(o) of the Act, 21 U.S.C. 352(a), 352(o), and adulterated under section 501(f) of the Act, 21 U.S.C. 351(f).
If the manufacturer of an IVD product labeled IUO were to assist in the validation or verification of the performance of a test that the manufacturer knows is used in non-investigational clinical diagnosis using its IUO-labeled IVD, FDA would consider such assistance to be evidence of non-investigational intended use. As explained above, this may render the device misbranded under sections 502(a) and 502(o) of the Act, 21 U.S.C. 352(a), 352(o), and adulterated under section 501(f) of the Act, 21 U.S.C. 351(f).
as an mere guesswork...what i would assume is that, by labeling the product as RUO, the responsibility & liability of performance (/validation) would have to be shared by you; apart from comparative data to be generated.,
what i would guess is that, placing the product as LUO, you might get away by your own verification procedures. (delink with the end application or .,.. it would become end users responsibility to validate etc)
hope to hear it from experts...though...
 
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