U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. News & Events (Medical Devices)
  4. Workshops & Conferences (Medical Devices)
  5. Virtual Public Workshop - Orthopedic Device Postmarket Review - 06/10/2021 - 06/10/2021
  1. Workshops & Conferences (Medical Devices)

Workshop

Event Title
Virtual Public Workshop - Orthopedic Device Postmarket Review
June 10, 2021


Date:
June 10, 2021
Time:
8:30 AM - 4:00 PM ET

The Food and Drug Administration (FDA) is announcing a virtual public workshop entitled “Orthopedic Device Postmarket Review.” This workshop is intended to enhance public understanding of FDA’s postmarket activities related to the regulation of orthopedic devices under 21 CFR Part 888. The purpose of the workshop is to share information with stakeholders, including members of the orthopedic community, device manufacturers, regulatory affairs professionals, clinicians, patients, and the general public, on FDA regulations, guidances, and programs related to orthopedic device postmarket activities and challenges that are commonly faced in this area.

Background

This public workshop seeks to share knowledge pertaining to FDA’s postmarket programs and activities in the regulation of orthopedic devices. The goal is to provide an overview and description of the requirements related to Recalls, Medical Device Reporting (MDR), Post-Approval and Postmarket Surveillance (522) Studies, Inspections, and Postmarket Approval Reporting. The main objective of this public workshop is to improve public understanding of medical device postmarket programs and regulatory requirements related to orthopedic devices. This workshop considers the role of benefit and risk in FDA decision making and mitigation measures for minimizing these risks.  The public workshop is not intended to communicate any new policies or processes. The topics for discussion include Recalls, MDR, Post-Approval and Postmarket Surveillance (522) Studies, Inspections, and Postmarket Approval Reporting. Presenters will discuss potential strategies to address challenges in these areas and ongoing analysis and trends to help orthopedic device stakeholders strategize and implement various corrective actions and design changes.

DATE and TIME

This meeting will be held June 10, 2021, from 8:30 a.m. to 4:00 p.m. ET by webcast only.

WEBCAST WORKSHOP LINK

The virtual public workshop can be viewed at the following link: https://fda.yorkcast.com/webcast/Play/547e1f1b1c7140a38a264742774e88651d

The archived webcast can be viewed at this same link, 1 day, after the public workshop.

AGENDA

TIME TOPIC PRESENTER
8:30-8:45 a.m. Welcome and Opening Remarks CAPT Raquel Peat, PhD, MPH, FDA

Master of Ceremony: Jon Speer, BS, Greenlight Guru

Session 1:  Recall and Medical Device Reporting (MDR)
Moderators: John Gomes, MS, FDA and Linda Braddon, PhD, Secure BioMed Evaluations
8:45-9:00 a.m. Recalls Overview and Requirements Danielle Cristino, PhD, FDA
9:00-9:15 a.m. Recalls Best Practices Jay Kadakia, MS, FDA
Joseph Russell, MS, FDA
9:15-9:25 a.m. Recalls Analysis/Trends Teresa Palacios-Hernandez, PhD, FDA
9:25-9:40 a.m. Menti Survey  Sahlee Sabala, MPH, FDA
9:40-9:50 a.m. MDRs Overview and Requirements Carole Wolfe, MS, FDA
9:50-10:00 a.m. MDRs Best Practices Jennifer Houck, MS, FDA
10:00-10:10 a.m. MDRs Analysis/Trends Alexander Rodriguez, MS, FDA
10:10-10:20 a.m. Industry Perspective on MDRs and Recalls Stephanie Matthews, MBA, Johnson & Johnson
Kara Ditty-Bovard, BS, Johnson & Johnson
10:20-10:30 a.m. Patient Perspective on MDRs and Recalls Richard Seiden, JD
10:30-10:40 a.m. Menti Survey Ting Song, PhD, RAC, FDA
10:40-11:00 a.m.

Break

11:00-11:30 a.m. Group Discussion James N. Walker, BS, FDA
Michelle Rios, MS, FDA
Richard Seiden, JD
Stephanie Matthews, MBA, Johnson & Johnson
Kara Ditty-Bovard, BS, Johnson & Johnson
Jennifer Harris, BS, Acumed/Osteomed
Erika Guthrie, MS, Acumed/Osteomed
11:30-12:30 p.m.

Lunch Break

Session 2: Post Approval Study (PAS) and Postmarket Surveillance (522) Studies
Moderators: Nilsa Loyo-Berrios, PhD, MSc, FDA and Russell A. Schenck, PhD, Zimmer Biomet
12:30-12:45 p.m. PAS and 522 Studies Overview and Requirements Carolina Alvarez-Garriga, MD, DrPH, FDA
12:45-1:00 p.m. PAS and 522 Studies Best Practices Hongying Jiang, PhD, RAC, FDA
1:00-1:10 p.m. Real World Evidence Case Studies Victoria Lilling, MD, FDA
1:10-1:20 p.m. Industry Perspective on PAS
and 522 Studies
Paul Coplan, ScD, MBA, Johnson & Johnson
1:20-1:30 p.m. Menti Survey Michael Owens, MS, RAC, FDATBD
1:30-2:00 p.m. Group Discussion Hongying Jiang, PhD, RAC, FDA
Carolina Alvarez-Garriga, MD, DrPH, FDA
Hong Cheng, MD, PhD, MPH, FDA
Veronica Sansing-Foster, PhD, MS, FDA
Paul Coplan, ScD, MBA, Johnson & Johnson
2:00-2:10 p.m.

Break

Session 3: Inspections and Postmarket Approval Reporting
Moderators: Shumaya Ali, MPH, FDA and Jon Speer, BS, Greenlight Guru
2:10-2:25 p.m. Medical Device Single Audit Program LCDR Jacob Dyer, PE, PMP, FDA
2:25-2:35 p.m. Inspections and Establishment Inspection Report (EIR) John Gomes, MS, FDA
2:35-2:45 p.m. Pre-Market Approval 
Manufacturing Quality System
Review
Zhijiang He, PhD, FDA
2:45-3:00 p.m. 30 Day Notice vs Annual Report Ting Song, PhD, RAC, FDA
Sita Modali, PhD, FDA
3:00-3:15 p.m. Industry Perspective on
Inspections and Good
Manufacturing Practice Review
Jennifer Harris, BS, Acumed/Osteomed
Erika Guthrie, MS, Acumed/Osteomed
3:15-3:25 p.m. Menti Survey Ting Song, PhD, PhD, RAC, FDA
3:25-3:50 p.m. Group Discussion Dharmesh Patel, MBA, FDA
Jhumur D. Banik, MS, FDA
Eric Horowitz, MS, FDA
LCDR Jacob Dyer, PE, PMP, FDA
Stephanie Matthews, MBA, Johnson & Johnson
Jennifer Harris, BS, Acumed/Osteomed
Erika Guthrie, MS, Acumed/Osteomed
   
3:50-4:00 p.m. Closing Remarks William Jung, PhD, FDA

REGISTRATION

Registration is closed. The Webcast Workshop link is above.

COMMENTS

Please submit your comments regarding the workshop to https://www.regulations.gov, Docket No. FDA-2021-N-0414 by July 12, 2021.   

Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is received. 

The resulting discussions from the workshop and comments received in the docket will be taken into consideration.

Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible at http://www.regulations.gov

CONTACT

For questions regarding workshop content please contact:

Sahlee Sabala
Regulatory Health Project Manager
Office of Health Technology 6
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Food and Drug Administration
240-402-2573
OHT6-Feedback@fda.hhs.gov
CDRHpublicmeetings@fda.hhs.gov

REFERENCES

Back to Top