Posted by: LinksEtc
« on: March 09, 2013, 08:57:43 AM »Food and Drug Administration
[Docket No. FDA–2013–D–0168]
Draft Guidance for Industry and Food and Drug Administration Staff:
Recommendations for Labeling Medical Products To Inform Users That
the Product or Product Container Is Not Made With Natural Rubber Latex;
Availability
http://www.gpo.gov/fdsys/pkg/FR-2013-03-11/pdf/2013-05554.pdf
[Docket No. FDA–2013–D–0168]
Draft Guidance for Industry and Food and Drug Administration Staff:
Recommendations for Labeling Medical Products To Inform Users That
the Product or Product Container Is Not Made With Natural Rubber Latex;
Availability
http://www.gpo.gov/fdsys/pkg/FR-2013-03-11/pdf/2013-05554.pdf
Quote
FDA is concerned that statements submitted for inclusion in medical product labeling
such as ‘‘latex-free,’’ ‘‘does not contain natural rubber latex,’’ or ‘‘does not contain latex’’
are not accurate because it is not possible to reliably assure that there is an absence of the allergens
associated with hypersensitivity reactions to natural rubber latex in the medical product.
Quote
submit written or electronic comments on the draft guidance by June 10, 2013