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FDAcdrhIndustry

  1. Exemption From Premarket Notification: Wheelchair Elevator (inclined/vertical platform lifts) 1.usa.gov/N3mlYB #fda #medicaldevice
  2. Exemption From Premarket Notification: Powered Patient Transport (stairlifts) 1.usa.gov/KDD3MJ #fda #medicaldevice
  3. 6/27-28/12: Orthopaedic & Rehabilitation Devices Committee; Amendment of Notice 1.usa.gov/L36dkU #fda #medicaldevice
  4. Update to the 2012 Small Business Qualification Guidance 1.usa.gov/qzblBH #fda #medicaldevice
  5. MQSA Alt Standard #21: Correct Period When Comps of Agfa CR Full Field Digital Mammography Sys Fail Q C 1.usa.gov/Kh0FYC #fda
  6. Waiver & Acknowledgement letter for 6/13/12 Circulatory System Devices Committee Mtg 1.usa.gov/JpOIz0 #fda #medicaldevice
  7. 24 Hour Summary & Presentations 5/24/12 Circulatory System Devices Committee Mtg 1.usa.gov/JpOIz0 #fda #medicaldevice
  8. Proposed collection of info on IDE Reports & Records - comments due by 7/23 1.usa.gov/KdCE2W #fda #medicaldevice
  9. Circulatory System Devices Panel- May 24 meeting materials 1.usa.gov/JpOIz0 #fda #medicaldevice
  10. New CDRH Learn Module - Medical Device Recalls: Guidance for Industry 1.usa.gov/aYqTJd #fda #medicaldevice
  11. Public Meeting - Clinical Study Design & Performance of Hospital Glucose Sensors, 6/25/12 1.usa.gov/JCForR #fda #medicaldevice
  12. Steps 4 requesting speakers from device center 2 participate in your org's mtgs, conferences 1.usa.gov/Mb2lQP #fda #medicaldevice
  13. RT @fdawomen: #FDA wants your input on drug, device, & biologic approvals. Join webinar 5/18 9am EST: ow.ly/aV5uG #medicaldevice
  14. Public Workshop - Device Improvements 4 Pediatric X-ray Imaging, 7/16/12 1.usa.gov/J9ciy1 #fda #medicaldevice
  15. Draft Guidance - Pediatric Info for X-ray Imaging Device Premarket Notifications 1.usa.gov/KQPiRg #fda #medicaldevice
  16. The Triage Pilot: Increasing Efficiencies for Device Review 1.usa.gov/IF1Bie #fda #medicaldevice
  17. De Novo summary/approval ltr for InBios DENV Detect IgM Capture ELISA - K100534 1.usa.gov/wK3wEB #fda #medicaldevice
  18. Proposed Info Collection; Administrative Detention & Banned Medical Devices 1.usa.gov/HvU6Qa #fda #medicaldevice
  19. Factors 2 Consider When Making Benefit-Risk Determinations in Med Dev PMA & De Novo Classifications 1.usa.gov/HyVjDF #fda #medicaldevice
  20. Guidance for Industry & #FDA Staff - User Fees for 513(g) Requests for Information 1.usa.gov/d1Y0QM #medicaldevice