Back to Top
Categories
Tags
Authors
Teams
Archives
Categories:   All Categories
Suggested keywords
x
  Print

Developing a Spinal Plate Now or In the Near Future?

725 Hits
Spinal-Plate-Assy.jpg
Developing a Spinal Plate Now or In the Near Future? If so, you may want to download the latest draft guidance from the FDA titled "Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway". See link below. They've released this as a DRAFT only at this time in order to gain industry comments. But it shows that the FDA is definitely heading towards a performance pathway that does not require obtaining and testing predicate devices. This will be a major improvement and will likely speed up development and 510(k) submissions, since performance and safety targets will be known and easily available. I think these changes will be particularly helpful to small and startup companies.
 
If you need professional and experienced engineering for your spinal project, contact Engineering & Quality Solutions, Inc. today!
0
×
Stay Informed

When you subscribe to the blog, we will send you an e-mail when there are new updates on the site so you wouldn't miss them.

EQS Presented at ASTM Workshop on Medical Device S...
New FDA Guidance for Medical Device 510(k) Submiss...

About the author

Victoria Trafka

Victoria Trafka

Subscribe to updates from author Unsubscribe to updates from author Victoria Trafka
Author's recent posts
More posts from author
 

Comments

No comments made yet. Be the first to submit a comment
Already Registered? Login Here
Thursday, 25 April 2024

SWE Logox150
Copyright Engineering & Quality Solutions, Inc
 ASTM member logox100

 

Consulting in: Medical Device, Orthopedic & Spinal Devices, Product Development, Design, 3D CAD,

Engineering, Finite Element Analysis, FEA, Quality Management System, QMS, ISO 13485,

ISO 9001, FDA Compliance, FDA 21 CFR 820, Design History Files & Remediation