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(FDA) final guidance on “Bone Anchors – Premarket Notification (510(k)) Submissions” is based on the agency’s draft guidance from January 2017.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.
Angela Mallery, EdD, is a Principal Product Development Strategist at NAMSA with over 25 years of experience working in device regulatory affairs in small, medium, and large sized companies. Angela has experience in project management, regulatory strategies, pre-submission meetings; and has hands-on experience developing, writing, and receiving clearance/approval for 510(k), IDE submissions and reports, PMAs, CEP/CERs, and Technical File/Design Dossier submissions. Angela’s therapeutic experience includes cardiology, neurology, peripheral vascular devices, general surgical devices and orthopedic implants.