Global Regulatory Pulse

FDA Releases Final Guidance on Bone Anchor Premarket Notification (510(k)) Submissions

In FDA, Regulatory by Angela Mallery0 Comments

This week’s release of the U.S. Food and Drug Administration’s (FDA) final guidance on “Bone Anchors – Premarket Notification (510(k)) Submissions” is based on the agency’s draft guidance from January 2017. While there are no significant differences between the draft document and the final guidance, the FDA did update this document to reflect other released guidance documents and minimal revisions.

Required information for premarket notification submissions (product descriptions) includes:

  • General dimensions
  • Assembly of multiple components and the mechanism on attachment
  • Information on sutures, if provided, or sizing information for sutures not provided
  • Bone preparation
  • Material or device-specific details, when appropriate

Within the guidance, additional helpful data points and information are provided:

  • Lists of specific bench tests
  • Examples of when human data may be required
  • Examples of when a new 510(k) may be required
  • Information to be included within the Indications for Use and the Directions for Use
  • Example of the Substantial Equivalence Table
  • List of biocompatibility tests to consider
  • Basic information on sterilization, reusability, packaging, and magnetic resonance (MR) compatibility
  • List of bench tests to be considered, including sample sizes for the bench testing
  • Brief summary of when clinical data may be required

The FDA’s full guidance may be found here.

How Can NAMSA Help?
Navigating the U.S. FDA regulatory landscape can be overwhelming for any medical device manufacturer – not to mention very cost-intensive. That’s why having the right partner, at the right time, can be invaluable in achieving reimbursement requirements, market success and accelerated timelines.

NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the FDA. In fact, our internal teams of medical device development experts communicate with the FDA nearly every day. From Pre-Submission meetings – to Pre-IDE preparation – and FDA inspection preparation, our teams are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers. This expertise has been proven to save medical device organizations up to $17M in costs and 23 months in development timelines.

If you are interested in speaking with us about FDA-related activities or other global regulatory strategies, please contact us at: https://www.namsa.com/contact-us.

Authors:

Angela Mallery EdD, has over 25 years of experience working in device regulatory affairs in small, medium and large sized companies. Angela is a project manager and regulatory consultant for NAMSA on worldwide device regulatory registrations; including cardiac and peripheral devices, tissue products and urology devices. She also holds an adjunct faculty position at St. Cloud State University, teaching in the regulatory program.

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