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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 Staff”¹ and “Refuse to Accept Policy for 510(k)s; Guidance for Industry and Food and Drug Administration Staff”² 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)s”³, 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 Staff”⁴, 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 Sterile”⁶ and “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”⁷, 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
• Webcast Archive
• Agenda
• Transcript
• Comments
• Contact
• References

DATE and TIME

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

WEBCAST ARCHIVE

The archived webcast is available for viewing, for one year, at the following link:  http://fda.yorkcast.com/webcast/Play/210a29e5d41040378d0fbb9ac95abf431d  Slides are embedded in the Agenda under “Topic” for the presentations.

AGENDA

TRANSCRIPT

• Transcript for August 13

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
[email protected]

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.