[DIYbio] Re: [CCL] lab-on-a-chip

Looking forward to hearing more details about your idea!

At the moment, the IndieGogo video looks more like one of those frustrating Hollywood movie trailers: maximized for hype while trying to give away as little of the plot as possible. All it needs is a gravely voice-over going "In a world, where 90% of the population lacks access to diagnostics tests, one man..."

More content please!

Especially in an area like rapid diagnostics using microfluidics, where there are dozens of well-funded efforts that have years of head start trying to achieve the same thing, it's important to point out how what you're doing is so significantly different.

Also, since your Indiegogo page states that 'The mantra is "open-source diagnostics."' - I would expect to see more than just a few hints about what your innovation in microfluidics technology is based on. Do you have an openly accessible repository where you keep all your design files, for example?

Thanks!

Patrik

PS: The best way to resolve the "send a chip to developing countries" reward would be to say that you will donate chips to a specific named research organization working in a developing country on the diseases you're targeting. Building that kind of collaboration "on the ground" will likely be essential if you hope to make an actual difference in a place where even a $5 assay may be more than people can afford...

On Fri, Nov 22, 2013 at 9:56 AM, Thomas Warinner <gren...@gmail.com> wrote:

Hey guys,

I'm bulking up the indiegogo for you guys to make this more clear. That should be done by the end of the day. I only tried to keep it simple for Indiegogo users. As for the "education purposes only" on my electrophoresis products, I understood that "for educational use only" worked also for the FDA (biorad does as well). I talked to them before I put up that disclaimer- but I can also change that to make it more of the standard disclaimer. We have a really small team here. We work to the best of our abilities to do marketing and provide the appropriate information- but it's obviously lacking. I appreciate the critical feedback, truly. We've never engaged in marketing or business before this, we just wanted to take on projects that pushed our design capabilities.

The Indiegogo will be updated for all the questions here, and also handed out my personal cell phone to many people on the board.

Cheers,

Thomas

 

On Friday, November 22, 2013 8:13:20 AM UTC-8, hbergeronx wrote:

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm253307.htm

Listing the device as "for educational purposes only" is not the same as a part 812 exception. There are very clear guidelines from the FDA on how medical devices must be labeled and marketed. Learning said regulations is an important part of developing medical devices, at least here in the US. 

Offering to send a chip to developing countries for (apparent) diagnostic purposes is incompatible with a declaration of investigational or educational use. 

-matt

Device Investigations Exempt from IDE Regulation
Investigations of diagnostic devices that meet the criteria at section 812.2(c)(3) are exempt from the regulations at 21 CFR 812, with the exception of section 812.119. The criteria at section 812.2(c)(3) include specifying that testing:

• be non-invasive,
• not require an invasive sampling procedure that presents a significant risk,
• not by design or intention introduce energy into a subject, and
• not be used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.

The criteria in section 812.2(c)(3) also include compliance with labeling requirements section CFR 809.10(c), which exempts shipments and other deliveries of IVDs from certain labeling requirements if either (1) the device complies with part 812, or (2) the investigation is not subject to part 812 and one of the following conditions is met:

(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.''

(ii) For a product being shipped or delivered for product testing prior to full commercial marketing (for example, for use on specimens derived from humans to compare the usefulness of the product with other products or procedures which are in current use or recognized as useful), all labeling bears the statement, prominently placed: "For Investigational Use Only. The performance characteristics of this product have not been established.''

For purposes of this guidance document, "labeled RUO" refers to IVD products labeled in accordance with section 809.10(c)(2)(i); "labeled IUO" refers to IVD products labeled in accordance with section 809.10(c)(2)(ii) unless otherwise specified. Examples of products that meet the criteria for these designations are provided in Section III.

Because these products are exempt from most regulatory controls, it is important that they are not distributed for clinical diagnostic uses.

Mere placement of an RUO or IUO label on an IVD product does not render the device exempt from otherwise applicable clearance, approval, or other requirements. FDA may determine that the device is intended for use in clinical diagnosis based on other evidence, including how the device is marketed.

In general, if evidence shows that an IVD product is inappropriately labeled RUO or IUO, and that the product does not qualify for an investigational device exemption under 520(g) of the Act, and is not cleared, approved, or 510(k)-exempt, the device would be 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).

On Friday, November 22, 2013, Raymond McCauley wrote:

Final personal thought - listing the device as educational is not a dodge, but standard guidance and legal practice to help keep it from being used for diagnostics or medical use. Marketing a crowd-funded project as having potential in this area, without over-promising , is just trying to do some good world - saving

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