- 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
Several revised or updates USFDA guidance
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- UU – Final guidance – Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery
- US Final Guidance – Bone Anchors – Premarket Notification (510(k)) Submissions
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