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Greenberg testimony to FDA on IOM report on medical devices and 510(k) clearance

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September 16, 2011

Contact: NCL Communications, (202) 835-3323, This email address is being protected from spambots. You need JavaScript enabled to view it.

Testimony by Sally Greenberg, NCL Executive Director:

I want to thank the Center for Devices and Radiological Health for scheduling this public meeting to discuss recommendations from the Institute of Medicine on the 510(k) clearance process for medical devices.

The National Consumers League has been around since 1899. The League and has always been involved in improving health care access and obtaining quality health products for American consumers.We are pleased to have the opportunity to discuss the issues surrounding medical device testing. NCL acknowledges that some devices do not need to be tested in clinical trials to make sure they are safe and effective. However, we do believe that the FDA should require scientific proof of safety and efficacy in clinical trials (in other words, a PMA application) for all high-risk devices. This change would be consistent with the concerns expressed in the IOM’s report that the 510(k) process is not providing proof of safety or efficacy.

The FDA’s current classification system of which devices are high risk and which are moderate risk is inconsistent, and sometimes illogical. If a device can kill or seriously harm patients if it fails in a relatively predictable way, that’s a high-risk device. For example, almost all implanted devices, including all cardiac devices and artificial hips and knees should require PMAs, for example, because of the risks of failure.

It is true that an artificial hip may not save a life, but if a person is confined to a wheel chair if the artificial hip fails and they can’t undergo another surgery (either because of the expense or because of their health), that is a high-risk outcome. The risks and costs of additional surgery to replace defective implants makes them high-risk. It does not make sense that the FDA currently classifies almost all joint replacement knees and hips as “moderate risk.” It is even more disturbing that some cardiac devices, such as the vena cava filter (which has killed patients upon those instances when it has broken) ( were not required to be tested in clinical trials but instead are approved as 510(k) devices.

For devices that are truly moderate or lower risk and can safely be reviewed through the 510(k) process, FDA needs clear and expanded authority to conduct pre-market and post-market inspections of 510(k) devices. Currently they don’t conduct pre-market inspections and only do post-market inspections when problems have clearly arisen.

FDA needs clear and expanded authority to require post-market studies of 510(k) devices at the time of the 510(k) review. Currently, they can only do that if problems arise afterwards. It doesn’t make sense that devices that are not required to provide clinical trial data prior to approval can’t be required to provide clinical trial data after they are on the market.

We also believe that the FDA needs to make better use of its rescission authority for 510(k) devices, and improve or expand that authority if necessary. Currently, the agency doesn’t rescind approval of 510(k) devices and has previously said they don’t have the authority to rescind approval.

Another way we would recommend that the FDA incorporate the advice of the IOM report is to use a more stringent definition of “substantially equivalent.” IOM says that substantial equivalence should not be the key issue. Instead, proof of safety and efficacy should be key. Even within the current framework of substantial equivalence, FDA is supposed to consider whether changes affect safety and efficacy. FDA should focus more on those safety and efficacy questions and concerns.

Some moderate risk devices could remain a 510(k) rather than a PMA, but only with additional standards, such as scientific safety data. This would also respond to IOM’s concerns.

That completes my testimony. Thank you for giving me and the NCL the chance to weigh in on these vitally important issues related to the safety of patients with implanted medical devices.