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Zdrowie i gospodarka · 24.10.2019

Breast Implants-Certain Labeling Recommendations To Improve Patient Communication; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Breast Implants-- Certain Labeling Recommendations to Improve Patient Communication." This draft guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel- filled breast implants. FDA is seeking comments on all aspects of the draft guidance, including the respective benefits and risks of smooth and textured breast implants and applicability of the recommendations to both types. This draft guidance is not final nor is it in effect at this time.

Source: Federal Register — Food and Drug AdministrationOpen original release →