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FDA issues a new 510(k) guidance document - resorbable calcium salt bone void filler device.

The FDA continues to supply the industry with guidance documents for 510(k) applications. The newest one is for resorbable calcium salt bone void filler device.

This guidance document was developed as a special control guidance to support the classification of the resorbable calcium salt bone void filler device into class II (special controls). The device, as proposed, is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. This guidance is issued in conjunction with a Federal Register notice announcing the classification of the resorbable calcium salt bone void filler device.

Following the effective date of this final classification rule, any firm submitting a 510(k) premarket notification for a resorbable calcium salt bone void filler device, will need to address the issues covered in the special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should, in Agency guidances, means that something is suggested or recommended, but not required.

For more information on this guidance document please go to the following URL –

http://www.fda.gov/cdrh/ode/guidance/855.html or contact mdi at info@mdiconsultants.com.

.S. AGENT SECTION

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