Remember, at this date, only "new" products AFTER 8/8/16 are at issue.
There are a variety of ways manufacturers can prove a product was “commercially marketed” before the Aug. 8 2016 grandfather date. According to an FDA
guidance document, these are some examples:
- Dated copies of advertisements
- Dated catalog pages
- Dated promotional material
- Dated trade publications
- Dated bills of lading
- Dated freight bills
- Dated waybills
- Dated invoices
- Dated purchase orders
- Dated customer receipts
- Dated manufacturing documents
- Dated distributor or retailer inventory lists
Evolv is very conscious of this. Even the just released DNA250C is compliant. In order for the 250C to have features that werent available on 8/8/16, like Replay or 400w, an end user would have to load an "International" version of the firmware. As shipped, with "USA" firmware, it is compliant. If a USA
end user chooses to alter the product after they buy it, ie load different firmware to upgrade it to 400w, that is not currently illegal.
Also, in the last months leading to 8/8 Evolv was literally working around the clock, sleeping in their office, etc.. Many items were commercially "sold" by Evolv, to customers like HCIGAR, and a full documentation trail was created. Many of these items have not been produced on a mass scale yet, but small batches were produced and sold/invoiced/shipped (Bills of Lading)/etc in order to get fully documented as being legally "under the wire".
Evolv has also heavily invested in the PMTA route, and is probably one of the best prepared to succeed via that route. PMTAs will be all about having the appropriate data, and Evolv has been
collecting a lot of data ever since the DNA75.
"data automatically recorded by your Evolv Products such as the statistical data associated with each puff of an e-vapor device made with an Evolv Product such as date, time, duration, temperature, energy, ambient temperature, resistance, draw volume, orientation, and other sensor and device parameter information,"
And Evolv has literally millions of hard data points.
Evolv also built
the analytical Vaping Device for the Department of Health and Human Services so they know what data is being collected that will likely be used as benchmarks in the PMTA process. See
this post (and the one directly above it) for a little background, Evolv did win this contract. Keep in mind that part of the deal is this:
"All intellectual property including patents and FDA filings will follow the standard data rights clauses. Please see page(s) 20, 23-24 of the RFP. The small business awardee owns, and has full right and title to, the data it develops under an SBIR award. Additional details can be found in Section 5.5 of the solicitation and here:"
So Evolv has an inside track to the data the Department of Health and Human Services is collecting.
Anyway, Evolv has done their due diligence, but it is all subject to a changing political environment.
While I have no inside info to this effect, I anticipate a Pod Mod type system to be submitted via the PMTA route. One with multiple coil cartridges to choose from, and a chip in the cartridge that identifies the coil material, resistance, safe temp range, etc that will tell the Mod how to perform and meet the stated PMTA criteria.