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  5. Virtual Public Workshop - Orthopedic Device Postmarket Review - 06/10/2021 - 06/10/2021
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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 will be a live webcast and the link will be provided in your confirmation email if you registered.  The link for archived webcast will be posted to this webpage for viewing after the public workshop. 

PRELIMINARY AGENDA

This agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.

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

Master of Ceremony: Jon Speer

Session 1:  Recall and Medical Device Reporting (MDR)
Moderator(s):
8:45-9:00 a.m. Recalls Overview and Requirements TBD
9:00-9:15 a.m. Recalls Best Practices TBD
9:15-9:25 a.m. Recalls Analysis/Trends TBD
9:25-9:40 a.m. Menti Survey on Recall TBD
9:40-9:50 a.m. MDRs Overview and Requirements TBD
9:50-10:00 a.m. MDRs Best Practices TBD
10:00-10:10 a.m. MDRs Analysis/Trends TBD
10:10-10:20 a.m. Industry Perspective on MDRs and Recalls TBD
10:20-10:30 a.m. Patient Perspective on MDRs and Recalls TBD
10:30-10:45 a.m.

Break

10:45-11:00 a.m. Menti Survey TBD
11:00-11:30 a.m. Group Discussion
11:30-12:30 p.m.

Lunch Break

Session 2: Post Approval Study (PAS) and Postmarket Surveillance (522) Studies
Moderator(s):
12:30-12:45 p.m. PAS and 522 Studies Overview and Requirements TBD
12:45-1:00 p.m. PAS and 522 Studies Best Practices TBD
1:00-1:10 p.m. Industry Perspective on PAS and 522 Studies TBD
1:10-1:20 p.m. Real World Evidence Case Studies TBD
1:20-1:30 p.m. Menti Survey TBD
1:30-2:00 p.m. Group Discussion
2:00-2:10 p.m.

Break

Session 3: Inspections and Postmarket Approval Reporting
Moderator(s):
2:10-2:25 p.m. Medical Device Single Audit Program TBD
2:25-2:35 p.m. Inspections and Establishment Inspection Report (EIR) TBD
2:35-2:45 p.m. PMA Good Manufacturing Practices (GMP) Review TBD
2:45-3:00 p.m. 30 Day Notice vs Annual Report TBD
3:00-3:15 p.m. Industry Perspective on Inspections and PMA GMP Review TBD
3:15-3:50 p.m. Group Discussion
3:50-4:00 p.m. Closing Remarks William Jung, PhD, FDA

REGISTRATION

If you wish to attend this workshop, you must register by 4:00 p.m. on June 8, 2021. 

There is no fee to register for the workshop.  Registration will be on a first-come, first-served basis. 

No dashes or spaces in phone numbers please.
 

Registrants will receive confirmation when requests for participation have been accepted, if applicable. 

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Peggy Roney, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, Peggy.Roney@fda.hhs.gov.

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

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