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.

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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

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Meeting Summary

FDA QMS Harmonization Plan

• Harmonizing and Modernizing Regulation of Medical Device Quality Systems 

• FDA Transition to ISO 13485:2016 (download)

• Medical Device Companies Take Note: FDA’s Proposed Rule to Align ISO 13485 With its Quality System Regulation Moves Forward

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

• related to a few PIcc projects underway

• signed into law as part of the Consolidated Appropriations Act of 2021

• AMA toolkit (link to download)

• CMS Ending Surprise Medical Bills

• Federal Register

• AMA Implementation

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  • Health-tech companies back new legislation introduced to modernize ‘outdated’ health privacy laws (link)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