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FDAcdrhIndustry

  1. Proposed collection of info on IDE Reports & Records - comments due by 7/23 1.usa.gov/KdCE2W #fda #medicaldevice 8:52 AM May 24th via HootSuite
  2. Circulatory System Devices Panel- May 24 meeting materials 1.usa.gov/JpOIz0 #fda #medicaldevice 5:41 AM May 24th via HootSuite
  3. New CDRH Learn Module - Medical Device Recalls: Guidance for Industry 1.usa.gov/aYqTJd #fda #medicaldevice 6:13 AM May 23rd via web
  4. Public Meeting - Clinical Study Design & Performance of Hospital Glucose Sensors, 6/25/12 1.usa.gov/JCForR #fda #medicaldevice 5:52 AM May 22nd via HootSuite
  5. Steps 4 requesting speakers from device center 2 participate in your org's mtgs, conferences 1.usa.gov/Mb2lQP #fda #medicaldevice 7:50 AM May 21st via HootSuite
  6. RT @fdawomen: #FDA wants your input on drug, device, & biologic approvals. Join webinar 5/18 9am EST: ow.ly/aV5uG #medicaldevice 2:35 PM May 17th via HootSuite
  7. Public Workshop - Device Improvements 4 Pediatric X-ray Imaging, 7/16/12 1.usa.gov/J9ciy1 #fda #medicaldevice 10:17 AM May 9th via HootSuite
  8. Draft Guidance - Pediatric Info for X-ray Imaging Device Premarket Notifications 1.usa.gov/KQPiRg #fda #medicaldevice 10:14 AM May 9th via HootSuite
  9. The Triage Pilot: Increasing Efficiencies for Device Review 1.usa.gov/IF1Bie #fda #medicaldevice 9:52 AM Apr 17th via web
  10. De Novo summary/approval ltr for InBios DENV Detect IgM Capture ELISA - K100534 1.usa.gov/wK3wEB #fda #medicaldevice 5:52 AM Apr 13th via HootSuite
  11. Proposed Info Collection; Administrative Detention & Banned Medical Devices 1.usa.gov/HvU6Qa #fda #medicaldevice 12:07 PM Apr 10th via web
  12. Factors 2 Consider When Making Benefit-Risk Determinations in Med Dev PMA & De Novo Classifications 1.usa.gov/HyVjDF #fda #medicaldevice 12:05 PM Apr 10th via web
  13. Guidance for Industry & #FDA Staff - User Fees for 513(g) Requests for Information 1.usa.gov/d1Y0QM #medicaldevice 11:59 AM Apr 9th via HootSuite
  14. Guidance - #FDA & Industry Procedures for Section 513(g) Requests for Info under the FD&C Act 1.usa.gov/dgn3rl #medicaldevice 11:56 AM Apr 9th via HootSuite
  15. Innovation Pathway aims to reduce time & cost of bringing safe, effective, breakthrough tech to patients 1.usa.gov/AhUx6H #fda 9:53 AM Apr 9th via HootSuite
  16. Gastroenterology & Urology Devices Advisory Committee Meeting May 10-11, 2012 1.usa.gov/H0sFfb #fda #medicaldevice 6:54 AM Mar 28th via HootSuite
  17. Circulatory System Devices Advisory Committee Meeting May 24, 2012 1.usa.gov/HfVrGr #fda #medicaldevice 6:51 AM Mar 28th via HootSuite
  18. Factors 2 Consider When Making Benefit-Risk Determinations in PMA & De Novo Classifications 1.usa.gov/H9DV58 #fda #medicaldevice 6:47 AM Mar 27th via web
  19. Online video - ISO 13485:2003 Voluntary Audit Report Submission Pilot Program 1.usa.gov/GSwiA0 #fda #medicaldevice 10:50 AM Mar 23rd via web
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