ABSTRACT
Since legal jargon and statutes are often difficult for even the most skilled regulator or attorney to understand, it may be helpful to consider a prophetic example of the analysis utilized to determine if a medical device that utilizes nanotechnology is eligible for PTE. For the analysis, assume that fictitious Nanocompany 1 from Nanoville, USA, develops a new endosseous implant for treating bone loss that they call Nanoendoplant (NEP). NEP comprises novel nanoparticles, which have been patented by Nanocompany 1. In addition, assume that no other products currently used or marketed in the United States are equivalent to NEP (1) Is NEP a medical device subject to regulation under the FD&C
Act? Yes Since NEP is an apparatus for treating bone loss, NEP is considered a medical device within the meaning of the FD&C Act. Accordingly, NEP is subject to regulation under the FD&C Act. (2) Will NEP require PMA prior to commercial marketing? Yes As discussed, in order to determine whether PMA will be required, one must first determine whether NEP will be classified as a class III device. Since treating bone loss by implanting a device may pose a risk of illness or injury to a subject, NEP will be classified as class III device. Accordingly, Nanocompany 1 will have to apply for PMA in order to obtain regulatory approval of NEP. (3) If NEP is granted PMA, do sales and/or use of NEP in the U.S. constitute the first permitted commercial marketing or use of the product pursuant to § 515 of the FD&C Act? Yes As discussed above, there are no equivalent Act equivalent products currently used or marketed in the US, the use and/or sales of NEP will constitute the first permitted commercial marketing or use of the product pursuant to § 515 of the FD&C Act.Applying the three-part analysis discussed above, a single patent, which claims either NEP itself, methods of using NEP or methods of manufacturing NEP, would be eligible for PTE based on the regulatory review period.
