UNAPPROVED IVDs COMMERCIALIZED UNDER INVESTIGATIONAL/RESEARCH-USE LABELING WOULD GET 18-30 MONTHS TO OBTAIN APPROVAL UNDER DRAFT CPG

Manufacturers commercializing unapproved in vitro diagnostics under the guise of research-use or investigational-use only labeling would have an 18-30 month grace period to gain FDA marketing go-ahead before being cited for violating premarket requirements, according to FDA's Jan. 5 draft compliance policy guide, "Commercialization of In Vitro Diagnostic Devices (IVDs) Labeled for Research Use Only or Investigational Use Only." The grace period would begin upon publication in the Federal Register of a notice of availability of the final CPG.