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  5. Public Workshop - Spinal Device Premarket Review - 08/13/2020 - 08/13/2020
  1. Workshops & Conferences (Medical Devices)

Workshop

Event Title
Public Workshop - Spinal Device Premarket Review
August 13, 2020


Date:
August 13, 2020
Time:
8:00 AM - 5:00 PM ET

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Spinal Device Premarket Review." The workshop is intended to enhance public understanding of FDA’s review of data and information submitted to support premarket authorization for spinal devices falling under 21 CFR 888.3070 and 21 CFR 888.3080 by highlighting key sections of a 510(k) submission. The purpose of this workshop is to share information with stakeholders including members of the orthopedic community, device manufacturers and industry consultants, on FDA issued product specific, and general guidances to improve submission quality and promote efficient review of orthopedic premarket applications. 

BACKGROUND

This public workshop seeks to share knowledge pertaining to FDA’s review of 510(k) submissions for spinal devices with those who are interested in preparing 510(k) submissions for such devices. The main objectives of this public workshop are: 1) to outline the 510(k) eCopy and RTA (refuse to accept) review as described in the “eCopy Program for Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff1 and “Refuse to Accept Policy for 510(k)s; Guidance for Industry and Food and Drug Administration Staff2 FDA guidances, and discuss common challenges, 2) to describe necessary elements of a 510(k) submission including device description and indications for use as outlined in the “Guidance for Industry and FDA Staff: Spinal System 510(k)s3, 3) to review mechanical testing described in the “Guidance for Industry and FDA Staff: Spinal System 510(k)s” and “Intervertebral Body Fusion Device - Class II Special Controls Guidance for Industry and FDA Staff4, 4) to discuss information outlined in FDA’s recently updated guidances including ”Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"5, ”Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile6 and “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling7, and 5) to discuss areas that need more clarity with device manufacturers and industry consultants.

The public workshop is not intended to communicate any new policies or interpretations regarding medical devices marketing applications and their review.

DATE and TIME

This public workshop will be held August 13, 2020, from 8 a.m. to 5 p.m. (ET) by webcast only.

WEBCAST

The public workshop will be webcast live and the link will be provided in your confirmation email if you registered to view the webcast. The link for archived webcast will be posted to the webpage for viewing after the public workshop.

AGENDA

The following public workshop Agenda is preliminary and subject to change. An updated Agenda will be posted in the registration website at least two-weeks before the public workshop.

Time

Presenter

Topic

Activity

8:00 – 8:15 a.m.

CAPT Raquel Peat, PhD, MPH Welcome and Introductions Presentation

8:15 – 8:30 a.m.

Zane Wyatt, PhD, MSc How to Avoid an eCopy Hold & eSTAR Presentation

8:30 – 8:45 a.m.

Brittany Ferrell, BS 510(k) Refuse-to-Accept Considerations Presentation

8:45 – 9:15 a.m.

Sharon Starowicz, MS (Industry Moderator)
  • Alexia Haralambous, MS, RAC
  • Allison Komiyama, PhD, RAC
  • Caroline Rhim, PhD
Industry Perspectives on eCopy and RTA Discussion

9:15 – 9:30 a.m.

Colin O’Neill, MBE Audience Survey (Menti) on eCopy and RTA Real-Time Survey

9:30 – 10:15 a.m.

Charles Warner, MS
Colin O’Neill, MBE
Device Descriptions and Indications for Use Statements Presentation

10:15 – 10:30 a.m.

Break

10:30 – 10:45 a.m.

Aakash Jain, MS Changes to an Existing Device Presentation

10:45 – 11:15 a.m.

Vikansha Dwivedi, BS Elements of a Quality 510(k) Submission Presentation

11:15 – 11:45 a.m.

Sharon Starowicz, MS (Industry Moderator)
  • Kelly Baker, PhD
  • Janice Hogan, JD
  • Glenn Stiegman, MS
Industry Perspectives on Device Descriptions and Indications for Use in a 510(k) Submission Discussion

11:45 – 12:15 p.m.

General Q&A

12:15 – 1:00 p.m.

Lunch

1:00 – 1:15 p.m.

Brent Showalter, PhD Audience Survey (Menti) on Performance Testing Real-Time Survey

1:15 – 2:15 p.m.

Jonathan Peck, ME
Katherine Kavlock, PhD
Spinal Device Mechanical Testing Presentation

2:15 – 2:45 p.m.

Steven Turtil, MS Sterility/Reprocessing/Packaging Considerations Presentation

2:45 – 3:00 p.m.

Break

3:00 – 3:30 p.m.

Aprajita Garg, PhD
Anne Talley, PhD, RAC, CQA
Biocompatibility Considerations Presentation

3:30 – 3:45 p.m.

Brent Showalter, PhD Audience Survey (Menti) on Performance Testing Real-Time Survey

3:45 – 4:15 p.m.

Sharon Starowicz, MS (Industry Moderator)
  • Lisa Ferrara, PhD
  • Danese Joiner-Fox, PhD
  • Dawn Lissy, MS
Industry Perspectives on Performance Testing Discussion

4:15 – 4:45 p.m.

General Q&A

4:45 – 5:00 p.m.

Ronald Jean, PhD Wrap Up and Adjournment Presentation

REGISTRATION

If you wish to attend this workshop, you must register by 11:59 p.m. on August 11, 2020. 

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.   There will be a one hour Q & A session.

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, 301-796-5671, peggy.roney@fda.hhs.gov, no later than July 24, 2020.

No dashes or spaces in phone numbers please.
 

COMMENTS

Please submit your comments regarding the workshop to https://www.regulations.gov/, Docket No. FDA-2020-N-1524 by September 14, 2020. 

Please refer to the Instructions for Submitting Comments to the docket to ensure that your feedback is taken into consideration.

CONTACT

For questions regarding workshop content please contact:

LCDR Ogochukwu Ogoegbunam, PharmD, BCGP, RAC
OHT6: Office of Orthopedic Devices
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66, Rm 4503
Silver Spring, MD 20993
240-402-8807
Ogochukwu.Ogoegbunam@fda.hhs.gov

REFERENCES:

1 The guidance eCopy Program for Medical Device Submissions; Guidance for Industry and Food and Drug Adminstration Staff” available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-submissions.

2 The guidance Refuse to Accept Policy for 510(k)s; Guidance for Industry and Food and Drug Adminstration Staff” available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks.

3 The guidance “Guidance for Industry and FDA Staff: Spinal System 510(k)s” available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-and-fda-staff-spinal-system-510ks.

4 The guidance “Intervertebral Body Fusion Device - Class II Special Controls Guidance for Industry and FDA Staff” available at: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/intervertebral-body-fusion-device-class-ii-special-controls-guidance-industry-and-fda-staff.

5 The guidance “Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and.

6 The guidance “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-information-premarket-notification-510k-submissions-devices-labeled.

7 The guidance “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-health-care-settings-validation-methods-and-labeling.

 

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