Jun 26, 2013

Latex Free Labeling Revisited

On April 23, 2013 the FDA issued draft guidance on the Use of ISO 10993, "BiologicalEvaluation of Medical Devices Part 1: Evaluation and Testing"

This guidance document would finally supersede Blue Book Memorandum #G95-1 for medical devices.  I won't go into much now, but it does include a section on Labeling Devices as "-Free" (such as Latex Free, DEHP Free, etc.) which I've cut and pasted below:

 So there you have it.  It seems reasonable and easier to label with "Not made with natural rubber latex" than to go with the old "Latex Free" which had ambiguous requirements.  While this guidance is still in its draft form, this section seems fairly non-controversial and I'm sure you could go ahead and start following it now without issue.

If you do not like the proposed rule, you are still free to comment on it by following the instructions on the guidance document.


Anonymous said...

It's funny how much time regulators spend on semantics. It would be ideal if they could devote more time to streamlining and overhauling requirements so that they are not only less burdensome but also more effective and relevant. I'm actually not an anti-regulation proponent. On the contrary, I believe strongly in regulation, when it's non-redundant, narrow and specific in focus, and in step with the exigencies of modern healthcare. I think that regulation should be completely overhauled every 5-10 years, with bonuses allocated to the admins who can streamline it and shorten the overall compliance.

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Jason said...

I agree with the anonymous previous comment: regulators spend definitely too much time on studying semantics.
I do believe that, on the otehr hand, a complete overhaul every 5-10 years wouldn't be appropriate: I would say that a 3-5 revision of the regulation would be fair.

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