Recently Posted Guidance Documents

Recently Posted Guidance Documents

9/13/2019 - Format for Traditional and Abbreviated 510(k)s: Guidance for Industry and FDA Staff 9/13/2019 - Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff 9/13/2019 - The Abbreviated 510(k) Program: Guidance for Industry and Food and Drug Administration Staff 9/13/2019 - The Special 510(k) Program: Guidance for Industry and Food and Drug Administration Staff 9/9/2019 - Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff 9/9/2019 - 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 9/9/2019 - User Fees and Refunds for De Novo Classification Requests : Guidance for Industry and Food and Drug Administration Staff Guidance Document Search Search all FDA official guidance documents and other regulatory guidance