Message from Leonard - FDA

[Guest guest]

I encourage them (women with health problems related

to their breast implants) to report this to MedWatch

at:

https://www.accessdata.fda.gov/scripts/medwatch/

or call them at 1-800-FDA-1088.

M. Leonard

Public Health Advisor

Consumer Staff, HFZ-210

Division of Small Manufacturers, International, and

Consumer Assistance Office of Communication, Education

and Radiation Programs Center for Devices and

Radiological Health

Phone: 1-800-638-2041 extension 141

Fax: 1-301-443-8818

This response represents to the best of my judgment

how the device should be regulated, solely based upon

a review of the information you have provided. This

response is not a classification decision for your

device and does not constitute FDA clearance or

approval for commercial distribution.

Unless exempt from premarket notification submission

(510(k))

requirements, the official classification for your

device will appear on the final decision letter from

any premarket review. All device types classified as

exempt from the 510(k) requirements are subject to the

limitations of exemptions. Limitations of device

exemptions are found in the device classification

chapters in 21 CFR xxx.9, where xxx refers to Parts

862-892 (e.g., 862.9, 864.9, etc.). Please be aware,

if I have indicated that I believe your device falls

within a device category classified as exempt from

premarket review requirements, that it is your

responsibility to ensure that you meet the exemption

criteria and your device does not exceed the

limitations of exemption. If your device exceeds the

limitations of exemption, you must sumit a 510(k) and

receive a letter from FDA stating that your device

may be commercially distributed in the U.S. prior to

marketing your device.

This communication is consistent with 21 CFR 10.85

(k) and constitutes an informal communication that

represents my best judgment at this time but does not

constitute an advisory opinion, does not necessarily

represent the formal position of FDA, and does not

bind or otherwise obligate or commit the agency to the

views expressed.