DISCLAIMER:  This Gemini SES+MDI study project is solely an initiative of the IHE-HL7 project team and is

not recognized or officially sanctioned by the U.S. FDA in any way. 

See FDA ASCA Pilot: Key Facts for more information.

When the ISO/IEEE 11073 SDC standards were advanced to IHE Devices (DEV) for profiling and testing, one of the core reasons was to leverage IHE's Conformity Assessment (CA) program, which is global in scope and had already been used for device-related CA both in IHE Connectathon testing events and product-focused CA leading to certification.  In 2020 this IHE CA testing was extended from the enterprise integration profiles like DEC and IPEC, to personal health devices (PHD) integrating work previously done by the PCHAlliance & "Continua".  This included not only IEEE 11073 support but also HL7 FHIR-based profiles.   The Gemini SES MDI using SDC / SDPi+FHIR program extends that use of IHE CA to address an ecosystem of plug-and-trust products around an acute point-of-care, recognizing that CA of this type of system integration - where individual products are developed in an independent "decoupled" manner - brings a new level of challenge for MedTech conformity assessment.

The fact that most of these "decoupled" interoperable MedTech products would each have to be independently cleared for market by the appropriate regulatory authorities has always been recognized as a significant regulatory science challenge, especially when considering dynamically integrated "ensembles" of devices that provide some degree of intelligence, autonomy, closed-loop control, Software as a Medical Device (SaMD) "apps", ... the REALITY of today's increasingly complex point-of-care "bed" environment.

In parallel, the U.S. FDA recently initiated a pilot project to determine if there was a path and process that would enable product developers to use CA test reports of frequently utilized medical device standards (e.g., ISO/IEC 60601 series) as part of their regulatory submission package.  A primary goal would be to streamline the FDA's review process based on confidence that recognized CA processes and certified labs could be done 

Given the above, the following question is proffered:  

Consider:  Can the SDC / SDPi+FHIR strategy for IHE Conformity Assessment (CA) process and tooling, that seeks to have "regulatory submission ready" test reports, be aligned with the FDA Accredited Standards Conformity Assessment (ASCA) pilot project such that a "FDA ASCA 'Ready'" approach can be achieved?  

In response to this question, a short term "pilot" project has been launched as part of the Gemini SES MDI program to look at a specific set of standards and specifications that are being profiled, compare the core constructs of the FDA and IHE CA programs, and determine if there is a clear path for achieving the goals for both programs using a single, harmonized process.

NOTE:  It is recognized that the U.S. FDA is only a single regulatory authority, the ASCAP is only a pilot project with a limited life (2022 September), the standards below are only a very strict subset of possible standards that could be considered, and IHE CA is only one program of many alternatives BUT by selecting these for a "pilot" feasibility project, we should be able to answer the above proposition using real-world elements that experts and enterprises are actively pursuing.  With success, broader and longer term application should be easily achieved.

The sections below provide background & overview on relevant topics - considering a "broad" audience - as well as the actual pilot project discussions, analyses and conclusions.  Enjoy!


What Lays Below ...

 


Overview:  FDA S-CAP / ASCA Programs & Pilots 

<overview & content from Resources below>

<include objective for this informal pilot to be informative ... but IHE CA would take the lead to actually DO it (smile)> 



"Accredited Standards" Considerations

<to do:  add discussion around accredited standards, accredited SDOs, national / international accreditation, relevance to FDA program (above), impact on key HIT SDOs, ISO Liaisons & PSDO relationships, etc. etc. etc.>


Overview:  IHE CA 

<link to home page ... graphic ...  Scheme Part 1 ... etc.>


The following illustration provides an overview of the IHE Conformity Assessment program:


Overview:  Gemini SES MDI / "Regulatory Ready" CA

<what is "Gemini" ... Hanging Gardens for Gemini ... SES MDI ... RI-TF-CA ... "regulatory submission ready" test reports" ...>

<RRCA (smile)_ >

<mention SOMEWHERE ISO/TC215/AHG4 CA>


Overview:  ISO/IEC 17000 & CASCO & NIST Basics

<very general overview that sets the stage for the following tables>


Inventory:  SES MDI Interoperability Standards for RI to CA

<using the HG model, identify the threaded standards that we want to use for this paper pilot project>

<include challenges with HL7/IHE/RFC etc. & non-consensus "standards" specifications & Profiles / IGs etc. - identify which of the items in the TABLE are what>


Crosswalk:  FDA ASCA & IHE CA

<TABLE linking the two ... ASCA Requirements / provisions & IHE CA profiles


Gemini FDA ASCA using IHE CA "Regulatory Ready" Pilot Project 

<project scope & timing ... i.e., very narrow (this page) and very short - couple months!>

<discussion notes, tasks, plans, nuts to crack ...>

<include unique components of Gemini SES MDI using SDC/SDPi+FHIR esp RI-TF-CA & MBSE/SysML/Cameo simulatable

<include MDIRA Profiles too...>


IHE "FDA ASCA at IHE CA for SDC/SDPi+FHIR" Pilot Project: 

Even though the 2021.04.13 ASCA presentation made it clear that additional consensus standards will not be possible for the current FDA pilot that concludes in September 2022, a near term feasibility / proof of concept Gemini project can be advanced that will 

a) establish a cross-walk between the IHE and FDA CA programs,

b) take the core recognized SDC & other 11073 standards and "pilot" their elements that would be needed for an FDA submission

c) create examples and templates that can be used for application of SDPi+FHIR for these submissions

d) draft a short summary report for submission to the FDA ASCA team 

e) (of course) Coordinate with FDA, NIST & IHE CA experts on (a) - (d) above!  (starting with Konstantinos Makrodimitris , John J. Garguilo / Amy Phelps, John Donnelly  and others ) 


Nuts to Crack:

  1. "IHE" is not a registered / recognized SDO (though other non-ANSI non-ISO/IEC/CEN standards development bodies are) - Can we change that in order to get recognition of SDPi profiles? 
    1. Some consider IHE an SDO, others do not.  What are the requirements?  What is the application process?  
    2. Note that in the FDA Recognized Standards database some organizations listed are not obvious or well known formal accredited (e.g., with ISO) SDOs (e.g., "Forum on Internet Response and Security Teams" or "Illuminating Engineering Society")  
    3. AND will the FDA (and similar) recognize IHE standards profiles?  Note that FDA DOES NOT recognize HL7 either.  Do they recognize standard profiles & implementation guides based on recognized standards?
      1. Other glaring omissions is the IETF or OMG that are foundational to much of what we do!
  2. Who is the "scheme owner" for the FDA ASCA program?  How "detailed" is that scheme for the pilot standards set?  (in other words, can it be thin and reference the IHE CA scheme for profiles?) 
  3. CA of foundational ISO/IEEE 11073 SDC "recognized" standards via Profiles of those Standards:  Can IHE CA for SDPi achieve both?
    1. FDA has recognized "foundational" standards such as IEEE 11073 or ISO/IEC 80001-1 
    2. FDA has not (yet) recognized IHE / HL7 standardized profiles and implementation guides 
    3. IHE CA directly tests "profiles" and indirectly the foundational standards that they are built upon
    4. CONSIDER:  Gemini SES MDI Requirements Interoperability - TF specification integration of RI artifacts + CA that includes both traceability and coverage for the component standards that drive the interface capabilities that are tested.
      1. IF the FDA does not recognize (any time soon) IHE and HL7 profiles and implementation guides that are implemented in MedTech products that are subect to regulatory review
      2. THEN the RI-TF-CA approach being pursued in the Gemini SDPi+FHIR program becomes even more important in that it can also provide conformity reporting (via tracability & coverage) back to the ISO/IEEE 11073 SDC standards that ARE formally recognized by the FDA
    5. As a related note ... What about the analogous situation with IHE DEV profiles based on HL7 V2  and also integrated (via gateway actors) into the IHE SDPi profiles specification?
      1. Though analogous, though, there are some critical differences :
        1. ISO & IEEE are recognized SDOs and ISO/IEEE 11073 SDC are recognized standards
        2. HL7 nor its standards (e.g., V2 or FHIR) are recognized by the FDA, so IHE profiles (like Alert Communication Management (ACM)) provide additional challenges to (d) above
      2. Note:  These IHE DEV PCD profiles ARE currently implemented into product that is cleared by the FDA for the market ... just sayin'! 
  4. Will product developers actually use this approach (per (3) above) if it is totaly "voluntary" as clearly stated by the FDA?
    1. Though voluntary, the FDA ASCA program does provide considerable value both to the developers and the FDA reviewers
    2. Making the Gemini SDPi+FHIR RI-TF-CA approach to "regulatory submission ready" CA test reports as something that is "free" (i.e., supported with out significant additional effort) makes alignment with the FDA ASCA program - at least to a "ASCA 'Ready'" stage, an obvious decision that does not require formal requirements / mandate from regulatory authorities
  5. ...


Pilot Team Participants

The following individuals have requested to be included in the CA & Tooling Team:

Todd Cooper

Konstantinos Makrodimitris

John J. Garguilo

Amy Phelps

John Donnelly

David Gregorczyk

Kenneth Fuchs

Michael Faughn









NOTE:  Team participants who are also registered HL7 Confluence users  be able to comment and add content.

Pilot Action Items / Tasks

Task report

Looking good, no incomplete tasks.




Pilot Discussion Notes

Note:  Some additional related discussions may be on the CA & Testing discussion notes page.


Note:  Include most recent first.


Agenda (proposed)

  1. General Review of Confluence Page (this page)
  2. Pilot Project planning discussion
  3. ...
  4. Next Steps / Next Call

Participants

<tbd>

Discussion Notes

Action Items / Tasks

<tbd>



<NOTE:  The ROUGH notes below should be cleaned up and screen shots deleted to the greatest extent possible>


FDA April 13 Workshop (convert below to content vs. rough notes...)

CDRH Industry Basics Workshop: Consensus Standards and the Accreditation Scheme for Conformity Assessment (ASCA) Pilot
4/13/2021 1:00 PM EDT Duration: 22:30

Note:  4/13 Industry Basics program video is available on the FDA website at the following - https://fda.yorkcast.com/webcast/Play/6c970c8d9bb74801b43c93420d10aae51d

Screen shots for integration below ...

     


Workshop screenshots (a) to be replaced when presentation published + (b) info integrated below ...


  • "How to Use Consensus Standards in Premarket Submissions" Notes
    The use of FDA-recognized consensus standards promotes predictability, advances regulatory science, and supports a least burdensome approach to medical device review. The first session of the Industry Basics Workshop will discuss how to use and reference standards in your device submissions.
  • Slide screen shots (to be replaced with ref. to actual presentation once available)
  • Notes from presentation (rough!!!) 
    • Scott Colburn
    • "standards" & "consensus standards" interchangeabily 
    • Value
      • Enhance Regulatory Science
      • Promote Quality
      • Improve Patient Access
    • Shout out to INTERNATIONAL standards 
    • DOC use (Declarations of Conformity)
      • "All normative requirements met" / All testing conducted / Finished device was tested
      • ISO/IEC 17050-1:2004 
      • See FDA 2018 Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
      • Supplemental Documentation:
        • Test Method / Acceptance Criteria / Complete Test Report needed? / Supplemental Documentation Needed?
        • See 17050-2 
        • Not needed IF Test Method & Acceptance Criteria are defined / provided 
    • Recognized Standards VOLUNTARY DoC value
    • FDA Form 3514 Cover Sheet Section J - CDRH Premarket Review
      • Entries for Utilization of Standards
      • NEED FDA standards Recognition Number 
    • Panel  - Ellias Millas sp?
      • Diane Nell,  Jianchao Zeng, Amir Razjouyan;  Scott Colburn
  • "The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions" Notes
    This session introduces the Accreditation Scheme for Conformity Assessment (ASCA) Pilot, which is intended to improve the efficiency of conformity assessment in device review. This session will share strategies for successful participation in the ASCA Pilot.
  • Slide screen shots (to be replaced with ref. to actual presentation once available)
  • Discussion Notes (rough!!!) 
    • Simon Choi
    • ASCA Goal:  Enhance the use of CA in Premarket Review
    • ASCA Pilot Overview
      • ASCA Recognition ... granted to accreditation bodies
      • ASCA accreditation ... granted to testing laboratories 
    • Premarket Submission
      • Steps
        1. ID ASCA Pilot Standards to be Cited (check ASCA Pilot web page)
        2. Develop & Agee on Test Plan w/ ASCA-accredited Test Lab
        3. Plan Submission Elements (cover letter w/ ASCA-specific info; DOC, summary test reports)
        4. Testing Laboratory performs test
        5. Prep FDA Submission
      • Cover Letter
        • ... 
      • DOC
      • ASCA Summary Test Report
    • Helpful Tips
      • Complete cover letter "ASCA Pilot Testing" called out
    • Panel Discussion
      • Members:  Elias Mallis (Moderator), Simon Choi, Scott Colburn, Angela deMarco, Diane Nell, Jianchao Zheng
      • NEW LIST POSTED YESTERDAY!!!  4/12 
      • Cover Letter:  Form 3514 provides a standardized way of providing info; BUT there is no ASCA section in the approved 3514 SO need a "hard copy of a cover letter" that provides the necessary information (see above)
      • Summary vs. Complete Test Reports needed?  IF DOC is submitted, the summary test report should be all that is needed BUT if there are mods / deviations ... a more complete TR may be required
      • Pilot will run through MDUFA 4 (September 2022) ... THEN permanent program in MDUFA 5 (if negotiations work)
    • QUESTION:  IS IT POSSIBLE to have additional standards (SDC/SDPi+FHIR) added to the pilot? OR should we target being informally ASCA "ready"
      • Diane Nell - Kosta ... ask!!!  
      • Scott:  Currently only 60601 + 80601(?) ... ;  "beginning to canvas standards that may benefit from ASCA in the future" ... but only investigating ...
      • ILAC is a key component for engaging "one test" internationally 
      • IHE CA in USA?  Germany?  17025 test houses 
      • Consider an IHE CA Briefing "Toward FDA ASCA Readiness"
      • Works very closely with NIST !!!!  (Scott...)
      • "as a scheme owner" ... ???!!!  is the FDA the scheme owner for these standards?!  








Resources & Links

  1. FDA Program Resources
    1. <briefing from FDA pages ... recorded>
    2. <FDA S-CAP home>
    3. FDA ASCA home>
    4. <include IMDRF document and a 2nd IMDRF document>
    5. ...
  2. IHE Conformity Assessment Resources
    1. <link to IHE CA home page>
    2. <link to IHE Scheme Part 1 document>
    3. <link to ... 
  3. NIST & ISO CA Resources

    1. Conformity assessment | NIST

    2. Conformity Assessment Resources for Federal Agencies | NIST 

    3. <ISO pages / CASCO pages>
  4. ISO/IEEE 11073 SDC Regulatory & CA Resources
    1. <link to ORNET.org papers>
    2. <SSch Unity presentation on the topic?>
    3. ...
  5. Standards & Specifications References & Links
    1. <link to ISO IHE TRs / TS'>
    2. <links to HG 
    3. <MDIRA links>
  6. Other Cool Stuff
    1. ...


THE INITIAL BRAINSTORMING CONTENT BELOW WILL GO AWAY ... 

To Do: 

  1. Integrate SDPi+FHIR Notes from confluence pages + emails to Amy/John G. 
  2. Get PDF links from Amy email?
  3. Migrate content below to pages above!
  4. Create email list for team members - include (a la SES RCC/MH table) list of team members) - THC, J.G., Kosta, JDonnelly, JR, ... 
  5. ...


FDA Resources 

See FDA Standards & CA home page for info & links


<Recognized Standards link> Recognized Consensus Standards (fda.gov)


NIST  Resources 


IHE CA Resources

  1. <include IHE CA background info>
  2. <include updated IHE CA artifacts>
  3. <linkages between ASCA and IHE CA ...>
  4. <templates ? for IHE DEV SDPi profile & FDA recognized standards>
    1. for example, Summary Test Report or DOC or Cover Letter (see above for all)

SDC Questions

  1. What is the 11073 SDC information that is called out in FDA Recognition?
  2. Are there any out-of-scope items in these standards?  
  3. How does the Recognition handle conditional and optional and extensions?
  4. FDA DOC Template form? see example in ISO/IEC 17050-1 ... recommend use of that form
  5. Test methods / acceptance criteria?