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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
FDA Grand Rounds: 5G Connectivity in Medical Devices: Landscape, Knowledge Gaps, and Regulatory Science Research
November 9, 2023


Activity Coordinators:
Sharron Watson (Sharron.Watson@fda.hhs.gov),  Rokhsareh Shahidzadeh (Rokhsareh.Shahidzadeh@fda.hhs.gov)
Series Description

The FDA Grand Rounds is webcast every other month to highlight cutting-edge research underway across the agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities.

Lecture Description
The lecture will describe the basics of 5G connectivity and how it relates to other wireless technologies. Potential uses of 5G for enabling novel medical applications or augmenting the use of existing ones will be discussed along with stakeholders input on knowledge gaps in this space. The focus will then be on research efforts to develop the groundwork for evaluating innovative 5G-enabled medical devices through regulatory science tools.
References
  • Qureshi, H.N.; Manalastas, M.; Ijaz, A.; Imran, A.; Liu, Y.; Al Kalaa, M.O. Communication Requirements in 5G-Enabled Healthcare Applications: Review and Considerations. Healthcare 2022, 10, 293. https://doi.org/10.3390/healthcare10020293
  • H. N. Qureshi, M. Manalastas, M. U. B. Farooq, A. Imran, Y. Liu and M. O. A. Kalaa, "5G-Enabled Healthcare in Mobile Scenarios: Challenges and Implementation Considerations," in IEEE Network, doi: 10.1109/MNET.125.2200243, https://ieeexplore.ieee.org/abstract/document/10032073
  • Medical Device Innovation Consortium, “Landscape Analysis of 5G in Healthcare”, Dec 2022, https://mdic.org/resource/landscape-analysis-of-5g-in-healthcare/
Series Objectives
  • Discuss the research conducted at the FDA
  • Explain how FDA science impacts public health
Learning Objectives After completion of this activity, the participant will be able to:
  • Describe 5G communication networks and their key technical enablers.
  • Explain use cases for using 5G connectivity in healthcare.
  • Discuss relevant knowledge gaps and regulatory science efforts to address them.
Target Audience
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency and external scientific communities.
Agenda

Lecture 1 November 9, 2023
Time Topic Speaker
12:00 - 1:00 PM EST 5G Connectivity in Medical Devices: Landscape, Knowledge Gaps, and Regulatory Science Research Mohamad Omar Al Kalaa, PhD
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-23-002-L99-P for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure

Faculty
  • Al Kalaa, Mohamad Omar, PhD, Electrical Engineer, U.S. Food and Drug Administration - nothing to disclose

Planning Committee
  • Dinatale, Miriam, DO, Team Leader, Food and Drug Administration - nothing to disclose
  • Pfundt, Tiffany, PharmD, Program Coordinator, FDA/CDER/OTBB - nothing to disclose
  • Wheelock, Leslie, RN, MS, Director, OSPD, FDA, OC, OCS, OSPD - nothing to disclose

CE Consultation and Accreditation Team
  • Bueide, Rachel E., MPhil, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
  • Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
  • Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
Registration Information
Registration is complimentary; therefore refunds are not applicable.