Thank you, Chairman Pallone.

I appreciate your holding this hearing today and I want to commend Chairman Dingell for his continued leadership on this important issue.

As a public health nurse I believe there is no greater goal than protecting the public’s health and wellbeing.

As part of its mission, the FDA is responsible for regulating all medical devices that are marketed in the United States, including those that are manufactured on foreign soil.

Inspections are probably the most powerful tool that the FDA has to ensure that these devices are safe and effective.

Yet, growing demands on the FDA have limited the resources it has available to adequately fulfill its mission.

As a result, inspections are far too infrequent and unsafe devices have the potential of entering the market undetected.

But device manufacturers also need to be part of the process.

We need to form a working partnership in order to guarantee a safe supply.

I am pleased that we will have an opportunity to hear today from both FDA and the medical device industry about how to make such a partnership work.

It is abundantly clear that the FDA is in desperate need of additional resources.

This fact has been acknowledged by my colleagues on both sides of the aisle.

It was confirmed by FDA officials testifying before this committee just this month.

And medical devices are not the only products that may be compromised by these limitations.

The FDA’s authority to regulate the cosmetic industry has been historically limited.

Cosmetic products and ingredients are not currently subject to rigorous premarket FDA inspection and approval, and it is left to the cosmetic industry to verify the safety of their products.

This limited oversight, combined with a lack of product recall authority, greatly constrain the FDA’s ability to protect consumers from potential toxins hidden in cosmetic products.

Without sufficient resources, adequate staff, and robust regulatory authority, the FDA has been relegated to a reactionary role instead of taking preventive and proactive measures.

This is no way to protect the public’s health and safety.

Changes need to be made, and in order to do this we must make a strong commitment to invest in the FDA, something I’ve supported throughout my tenure in Congress.

I thank the witnesses for taking the time to join us today and I look forward to a productive discussion.

Thank you and I yield back.

Pictured above: (center) Congresswoman Capps meets with Central Coast firefighters to discuss emergency preparedness.