Consumer Union - Comment

The is a Comment on the Food and Drug Administration (FDA) Notice: Medical Device User Fee Act Public Meeting

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Comments on the reauthorization of the
Medical Device User Fee Act

Docket NO. FDA-2010-N-0389

April 15, 2012

Medical devices, like eyeglasses and contact lenses, are a part of our everyday lives and are a growing part of the health care we receive. Complex devices like artificial hip joints, surgical mesh, and cardiovascular stents, are permanently implanted and can be essential for sustaining life. These high-risk devices can cause serious harm if they break, leak, stop functioning or disintegrate. When an implanted device is recalled or removed from the market, patients cannot simply stop using them. Removal of the device requires surgery, sometimes multiple surgeries, and it may take months or years to repair the damage done by the device. Many patients are permanently disabled due to complications from a device. Even low-risk devices, like contact lens solution and alcohol swabs have recently caused patients harm that could have been prevented.

Consumers Union urges the FDA and Congress to take a balanced approach to reauthorizing the Medical Device User Fee program, focusing on the real need to keep deficient and dangerous devices off the market while providing timely access to safe and effective devices. Safety failures resulting from failures in the device regulatory system, particularly the problematic 510(k) process, have caused serious harm to real consumers. Further, the system for monitoring and tracking what happens with devices once they are on the market is weak and does not adequately protect people using them.

Any reauthorization of MUDFA should improve safety and the current pathways followed to bring devices onto the market and improve the system of monitoring devices after being implanted in patients or sold to consumers. For example two specific policies that Congress should consider are: (1) legislation ensuring that devices that have proven faulty can not be used as the basis for clearing other subsequent devices; and (2) legislat



Consumer Union - Commitment Letter Comments

View Attachment:
Authors: CDRH

Comment Period Closed
Apr 16 2012, at 11:59 PM ET
ID: FDA-2010-N-0389-0031
Tracking Number: 80ff1ef0

Document Information

Date Posted: Apr 17, 2012
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Submitter Information

Country: United States
State or Province: TX
Category: Consumer Group - B0003