- June 10, 2021
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.
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.
This meeting will be held June 10, 2021, from 8:30 a.m. to 4:00 p.m. ET by webcast only.
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.
This agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.
|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)
|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|
|10:45-11:00 a.m.||Menti Survey||TBD|
|11:00-11:30 a.m.||Group Discussion|
|Session 2: Post Approval Study (PAS) and Postmarket Surveillance (522) Studies
|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|
|Session 3: Inspections and Postmarket Approval Reporting
|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|
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.
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.
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.
For questions regarding workshop content please contact:
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
- 30-day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Methods and Process Change (issued December 16, 2019)
- Center for Devices and Radiological Health Compliance Programs (as of September 15, 2020)
- Design Controls Guidance For Medical Device Manufacturers (issued March 11, 1997)
- Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions, Guidance for Industry and Food and Administration Staff (Issued December 27, 2016)
- Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C, draft guidance (issued April 2019)
- Medical Device Single Audit Program
- Post-Approval Studies (PAS) - Frequently Asked Questions (FAQ) (As of 02/20/2019)
- Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act, Guidance for Industry and Food and Drug Administration Staff (Issued on May 16, 2016)
- Procedures for Handling Post-Approval Studies Imposed by PMA Order, Guidance for Industry and Food and Drug Administration Staff (Issued on June 15, 2009)
- Product Recalls, Including Removals and Corrections (issued March 2020)
- Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C (issued February 2019)
- Quality System Information for Certain Premarket Application Reviews (issued February 2003)
- Questions and Answers about eMDR- Electronic Medical Device Reporting (issued February 14, 2014)
- Recalls, Corrections and Removals (Devices)
- Regulatory Procedures Manual
- Technical Considerations for Additive Manufactured Medical Devices (issued December 5, 2017)
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Guidance for Industry and Food and Drug Administration Staff (issued on August 31, 2017)
- Variance from Manufacturer Report Number Format [MDR Letter] (issued on July 1996)