Given the fast pace of technology and corresponding range of novel therapies under development today, you need an expert guide to help navigate the road to market.  HPM frequently counsels clients on the regulatory and market landscape for new products and existing products with new features.

We help our clients determine the jurisdictional boundary between the centers at FDA (i.e., CDER, CBER, CDRH, or CFSAN).  HPM has assisted numerous companies with the development of combination products and strategies for approval and routes to market.  In some cases, the determination involves the jurisdictional boundary between FDA and another agency such as the Consumer Product Safety Commission or the Environmental Protection Agency.

HPM has assisted numerous companies with the development of combination products and strategies for obtaining approval. HPM attorneys assist with filing requests for designation and advise companies on the relevant considerations with respect to primary jurisdiction by the different FDA centers.

Product examples

  • antimicrobial agents
  • pre-filled syringes
  • software products
  • wound care products
  • Contrast agents and imaging equipment
  • dermal fillers
  • drug delivery systems
  • orthopedic pain products
  • oral care products
  • inhalation products

 Common issues

  • requests for designation (RFD) and pre-RFDs
  • jurisdictional boundaries
  • risk assessment (of possible pathways)
  • premarket approval/clearance requirements
  • postmarket safety requirements
  • quality system requirements
  • data requirements for consulting Divisions
  • regulatory framework for constituent parts
Professionals

Related FDA Regulatory Categories