As stated previously, we understand that,
for some products, there may not be predicate products that were on the market as of February
15, 2007, to which to claim substantial equivalence. This may be particularly true for e-cigarettes
and similar novel products. For this reason, we are proposing that these manufacturers who
cannot use the SE pathway submit PMTAs to FDA no later than 24 months following the
effective date of the final rule. We are also proposing a 24-month compliance period for the
submission of SE reports. Therefore, FDA does not intend to initiate enforcement action against
products on the market for failing to have made an appropriate submission until 24 months
following the effective date of the final rule. If a manufacturer submits a PMTA or SE
application for its affected products within the 24-month time frame, FDA does not intend to
initiate action against those products for failing to have a marketing authorization unless and
until such a time as we have responded to the application.
manufactureres have 2 years form ruling to register products form 2007 on, that wont happen for another year or 2 then they have 2 years to do so, so we are looking at 3 to 4 years before any impact will happen with
devices. They need to register the product and they will not stop sales of those products until after the 24 month period if they havent registered it.