2/23/22 Steering Committee Meeting

 

Please find the slides from the meeting here.

 

This month’s meeting was well attended by a diverse group of stakeholders.

Please find the topics, all resources and content, along with a video recording of the meeting below.

We look forward to hearing from you.


Watch the recording of the meeting above.

0:00-3:32 Introduction

3:33-4:44 FDA QMS harmonization plan

4:45-7:15 DIDSR Opportunities

7:16-7:59 Transition Guidance for COVID-19 Devices

8:00-8:30 CDRH Annual Report

8:31-10:17 No Surprise Act

10:18-16:21 Privacy Project Updates

16:22-18:04 Closing Gaps in Cancer Screening

18:05-23:26 Patient Advocacy

23:27-32:58 Featured Papers

32:59-40:12 Upcoming Events

40:13-end Discussion


Meeting Summary

FDA QMS Harmonization Plan

DIDSR Opportunities

  • expanding fellowship opportunities (for PhD and masters candidates) to include professors with the aim to get higher level collaboration

FDA Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices

  • Plan to transition from emergency state to more permanent regulatory guidance regarding COVID-19 diagnostics

  • View recording of presentation and Q&A session (link)

CDRH 2021 Annual Report

  • shoutout and thanks to the agency

  • download here

 

No Surprise Act

Privacy Project Updates

  • ISPOR abstract not accepted

  • Health Data Use and Privacy Commission Act (link to legislation)

    • Privacy commission sign-on 2/9/2022 (link to letter)

    • Health-tech companies back new legislation introduced to modernize ‘outdated’ health privacy laws (link)

  • CommonWell Health Alliance (link)

Closing Gaps in Cancer Screening

  • Report to the President from the President’s Cancer Council (link)

  • independent of the Cancer Moonshot program

Patient advocacy updates

  • In contact with Sepsis Alliance to help them get started as a collaborative community

  • FOCR whitepaper: Expedited Development of Diagnostics for Therapies Targeting Rare Biomarkers or Indications (link)

  • APPIA board presentation

    • join pre-analytics planning meeting on Wednesday, March 2, 2022 at 1:00-2:00PM EST

 
 

Featured papers

  • Bulten et al. Artificial intelligence assistance significantly improves Gleason grading of prostate biopsies by pathologists (link)

 
  • Nguyen et al. Genomic characterization of metastatic patterns from prospective clinical sequencing of 25,000 patients (link)





 
  • Xie et al. Prostate Cancer Risk Stratification via Nondestructive 3D Pathology with Deep Learning–Assisted Gland Analysis (link)



 
  • Reid et al. Physician Compensation Arrangements and Financial Performance Incentives in US Health Systems (link)

 
  • von Stillfried et al. First report from the German COVID-19 autopsy registry (link)

 
  • Smit et al. Quality control of whole-slide images through multi-class semantic segmentation of artifacts (link)

  • Gallas et al. FDA fosters innovative approaches in research, resources and collaboration

 

Upcoming Events

  • March 1, 2022 at 1:00-2:30PM EST FDA Webinar - Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation - Final Guidance (link)

  • March 19, 2022 at 9:00PM PST Informal PIcc meeting at USCAP (link)

  • March 30, 2022 at 3:00-4:00 PM EST Next PIcc steering committee meeting (link)

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1/26/22 Steering Committee Meeting