4 Device De Novo Guidances Revised

FDA has revised four guidance documents based on a final rule on the medical device de novo classification process. For example, the guidance Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff provides further detail about the types of information FDA believes are necessary to conduct a substantive review for a de novo request, as well as the recommendations regarding the acceptance review process. The other guidances with revisions are:

• De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff
• FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff
• User Fees and Refunds for De Novo Classification Requests : Guidance for Industry and Food and Drug Administration Staff