FDA wants your comments!! Your chance to be heard – Unique Device Identification Convenience Kits

FDA announced an opportunity for public comment on the guidance document for Unique Device Identification Convenience Kits. Prior to the UDI rule, as per 21CFR 801.30 there was a general thinking that Medical procedure kits including orthopedic procedure kits are convenient kits. But the passage of UDI rule let to the interpretation that Implantable device, instruments provided as non sterile and repeatedly reconfigured or sterilized prior to use where not a part of Convenience kit.

The Objective of the UDI Rule of September, 24 2013 is to provide a system, to adequately identify a medical device through distribution and use. The draft guidance is being issued consistent with FDA’s good guidance practices regulation (31 CFR 10.115). As per the current draft guidance the term “Convenience Kit” applies solely to two or more different medical devices packaged together for the convenience of the user where they are intended to remain packaged together and not replaced, substituted, repackaged, sterilized or otherwise processed or modified before the device are used by an end user. When finalized the guidance document will constitute a change in the policy.

For your voice to be heard and your comments to be considered, submit either electronic or written comments on the draft guidance by April 4, 2016. Submit electronic comments to http://www.regulations.gov. Submit Written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 The Written Comments should include the Docket No. FDA-2015-D-4048 for “Unique device Identification: Convenience Kits; Draft Guidance for Industry and Food and Drug Administration Staff.” If you wish to submit any confidential information that you do not wish to be made publicly available submit written comments only, with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.”

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