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March Regulatory E-Letter

2019 DTA/FDA PROGRAM & REGULATORY WORKSHOP
EVENT DATES: April 17th - April 18th

FDA IN BRIEF
FDA takes steps to improve communications with medical device companies concerning corrective actions in response to inspectional observations. | LINK

NONBINDING FEEDBACK DRAFT
Nonbinding feedback after certain FDA inspections of device establishments. | LINK

IMPLANTABLE, LIFE-SAVING, & LIFE-SUSTAINING
List of medical devices, by Product Code, that FDA classifies as implantable,
life-saving, and life-sustaining devices.| LINK

DIGITAL HEALTH UPDATE
New FDA pre-cert working model now available. | LINK

IAF CERTSEARCH MARK
Rules for the use of the IAF CERTSEARCH Mark. | LINK

FDA MEDICAL DEVICE SYSTEM OVERHAUL 
FDA plans an overhaul of decades-old medical device system. | LINK

DSCSA: INTEROPERABLE DATA EXCHANGE IN 2023 
A look into the interoperable data exchange in the US pharma supply chain after the Enhance Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA) takes effect in November 2023. | LINK

RECENT NYT ARTICLE ON STANDARDS
A New York Times article focuses on the benefits of the voluntary standards and conformity assessment system managed by ANSI. It cites "the silent and often forgotten foundations of technological societies." The American Dental Association Standards Committees for Dental Informatics (SCDI) and Dental Products (SCDP). The ADA is the U.S., ANSI accredited, standards developing organization for dental informatics and products. | LINK

    DA SCDI REFLECTIONS
    Napoleon  Monroe attended the American Dental Association Standards Committee for Dental Informatics (SCDI)  on behalf of his firm, New Directions Technology Consulting. Here are his takeaways on new directions for the dental standards community:

    • Interoperability with the medical community  provides opportunities for research and services to improve individual and population health
    • While industry, manufacturers, and distributors have invested heavily in automated industry data capture, adoption has been quite slow.
    • Services  built on AIDC can result in cost reductions and profit opportunities for healthcare stakeholders, including those in  the dental industry
    • The size of the combined DoD and VA populations and DoD’s need to ensure health readiness for all missions has resulted in their  leadership toward interoperability
    • The growth of civilian institutional dentistry provides economies of scale to justify investments in interoperable systems  
    • Dental stakeholders can either lead or try to catch up later. 

    The recent closing SCDI Plenary summary detailed more on the "coming together", or the integration of dental and medical information through interoperability) SNOMED/SNODENT, ICD, CPT, DICOM, ISO CAD/CAM, ISO 13485 were cited from the podium and in breakout discussions. Also cited were numerous SCDI standards, white papers, technical reports, and working groups. Topics include managing dental knowledge, electronic prescribing, managing information on tissues of human origin, UDI, DSCSA, hardware and software configurations for the dental office, data security and other areas related to the oral healthcare marketplace. The work involved in "coming together" is informative and impressive. Participation in SCDI can stimulate in the industry and additional involvement, engagement, and support. 

    HEALTH CANADA'S ACTION PLAN ON MEDICAL DEVICES
    Health Canada's action plan on medical devices: continuously improve safety, effectiveness, and quality. | LINK

    DTA CO-SPONSORING UDI CONFERENCE
    DTA members enjoy a discount if they register for the UDI Conference, happening June 11th-12th in Baltimore, MD. | LINK