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Feb 02

New FDA Guidances for January 2016

Special Interest Guidances/Information Date Posted
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices– Draft Guidance 26-Jan-2016
Postmarket Management of Cybersecurity in Medical Devices- Draft Guidance 22-Jan-2016
Guidance Agenda: Guidances CDER is Planning 22-Jan-2016
Implanted Blood Access Devices for Hemodialysis– Final Guidance 21-Jan-2016
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile– Final Guidance 21-Jan-2016
Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products– Final Guidance 14-Jan-2016
Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donor of Human Cells, Tissues, and Cellular and Tissue-Based Products– Draft Guidance 8-Jan-2016
Unique Device Identification: Convenience Kits– Draft Guidance 4-Jan-2016
Upcoming Meetings (* = New)
  Meeting of the Psychopharmacologic Drugs Advisory Committee, 03 February; Silver Spring, MD
* Arthritis Advisory Committee, 03 February; Silver Spring, MD
* Cellular, Tissue, and Gene Therapies Advisory Committee, 16 February; Silver Spring, MD
  Risk Communication Advisory Committee, 16 February; Silver Spring, MD
  Risk Communication Advisory Committee, 17 February; Silver Spring, MD
  Circulatory System Devices Panel of the Medical Devices Advisory Committee, 18 February; Gaithersburg, MD
  Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee, 19 February; Gaithersburg, MD
  Gastroenterology and UrologyDevices Panel of the Medical Devices Advisory Committee, 25-26 February; Gaithersburg, MD
  Vaccines and Related Biological Products Advisory Committee, 04 March; Silver Spring, MD
* Circulatory System Devices Panel of the Medical Devices Advisory Committee, 15-16 March; Gaithersburg, MD
* Meeting of the Psychopharmacologic Drugs Advisory Committee, 29 March; Silver Spring, MD

* new entry
Last updated: 01 Febuary 2016