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US medical device registration and approval

US Regulators Offer Draft Pre-RFD Recommendations for Combination Products

EMERGO SUMMARY OF KEY POINTS:

  • New FDA guidance explains pre-request for designation (Pre-RFD) submission options specifically for combination product manufacturers.
  • All Pre-RFD submissions for combination products and potential combination products go through the FDA’s Office of Combination Products (OCP).
  • The Pre-RFD process is intended to address manufacturers’ questions regarding FDA classification and regulation.

USA: Entwurf für Pre-RFD für Kombinationsprodukte

ZUSAMMENFASSUNG DER WESENTLICHEN PUNKTE DURCH EMERGO:

  • In einem neuen Entwurf erläutert die FDA die Optionen für einen Vorabantrag auf Kennzeichnung (Pre-request for designation, Pre-RFD) für Kombinationsprodukte.
  • Alle Pre-RFD-Anträge für Kombinationsprodukte und mögliche Kombinationsprodukte werden vom Büro für Kombinationsprodukte (Office of Combination Products, OCP) der FDA bearbeitet.
  • Der Pre-RFD-Prozess soll Fragen der Hersteller in Bezug auf Klassifizierung und Regulierung klären.

US FDA Wants More Formalized Processes for De Novo Medical Device Classification Requests

EMERGO BY UL SUMMARY OF KEY POINTS:

  • US FDA has proposed formal policies and criteria for De Novo novel medical device classification requests.
  • The De Novo classification route allows some low- and moderate-risk devices for which substantial equivalence cannot be established to obtain US market access.
  • The proposed rules would set a 120-day review period for De Novo classification requests.