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GUIDANCE DOCUMENT

Breast Implants - Certain Labeling Recommendations to Improve Patient Communication Draft Guidance for Industry and Food and Drug Administration Staff October 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Submit Comments by

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-4467


Docket Number:
FDA-2019-D-4467
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. FDA is issuing this draft guidance to help ensure that a patient receives and understands the benefits and risks of these devices. The recommendations are being made based on concerns that some patients are not receiving and/or understanding information regarding the benefits and risks of these devices.