Recently Posted Guidance Documents on Labeling, Medical Devices, User Fees

Recently Posted Guidance Documents

Labeling

9/1/2017 Procedures for Meetings of the Medical Devices Advisory Committee - Guidance for Industry and Food and Drug Administration Staff

9/1/2017 Providing Regulatory Submissions in Electronic Format --Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling

Medical Devices

8/31/2017 Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff

8/31/2017 Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices - Draft Guidance for Industry and Food and Drug Administration Staff

User Fees

8/29/2017 FY 2018 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments

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