FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule

After 23 years, de novo classification review finally has an implementing regulation!

The other major review processes have had their regulations in place for many decades. The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Part 807, Subpart E). In 1986, FDA followed up with the PMA regulations (21 C.F.R. Part 814).