SOUND Devices Act on U.S. FDA approval of new medical devices UNsound?

It’s come to the attention of our Houston medical device injury lawyers that some U.S. lawmakers have introduced a bill they claim will give the U.S. FDA more authority to keep potentially harmful medical devices from reaching the market (and vulnerable patients). The Safety of Untested and New Devices Act of 2012 (called the SOUND Devices Act) relates to the 510k expedited approval process for medical devices.

The 510k process arose shortly after the FDA was created in 1976. The reach of the 510k expedited approval process expanded in 2002. This expansion allowed manufacturers even more leeway in gaining FDA market approvals for new medical devices that had not undergone safety research, testing, or clinical trials.

Under the 510k expedited process, manufacturers could receive U.S. FDA approval for a new medical device without conducting any separate safety testing or research on that device so long as it could be shown to be “substantially equivalent” to an older medical device already approved and on the market. These older devices already on the market are called “predicates.”

Our Houston medical device injury lawyers mention that there are several important things to note here: many predicates were never subjected to safety research, testing, or clinical trials themselves. Quite a few were “grandfathered” into approval when the FDA came into existence in 1976. And some of the predicates through which new devices received their “substantially equivalent” testing exemption had been recalled. And 99% of new medical devices (that is to say, almost ALL medical devices) receive FDA approval to go to the market through the 510k process.

The SOUND Devices Act makes an attempt at taking positive steps to remedy the giant safety loophole that is the 510k approval process. The Houston medical device injury lawyers at Denena & Points feel that any steps forward on the medical devices safety front could be beneficial. The Act’s potentially positive steps forward are:

• The Act would give the FDA authority to review and reject a 510k application if any of the new device’s predicates have been recalled or removed from the market for safety reasons.

• The Act would require manufacturers to inform the FDA if any of a new device’s predicates have caused serious harm to patients, and to explain how the new device will avoid causing the same harm.

• The Act would strengthen recall reporting requirements.

• The Act would require the development of a publicly-accessible database for manufacturers to use in determining whether a previous device could be used as a predicate.

Our Houston medical device injury lawyers point out some weaknesses of the SOUND Devices Act:

• The Act still does not generally strengthen safety research and testing requirements for new medical devices; it seems to only relate to the 510k expedited approval process for medical devices.

• The Act seems only to apply where a predicate has been recalled or is being removed from the market for safety reasons. Since many new devices are marketed for uses unlike and often fairly unrelated to the original device, and new devices can include substantial changes from the old one, the Act fails to anticipate the types of harm likely to happen and leaves large gaps in safety considerations.

• Where a new device’s predicates caused serious harm, the Act seems to only require that manufacturers explain how their new device will avoid causing the SAME harm as the predicate. Since new devices often contain new features, designs, materials, and equipment, and often serve quite different purposes from the predicate devices, this requirement could be largely irrelevant in anticipating harm and preserving your safety.

• The Act would seem to require better recall reporting. That’s all well and good. But by the time a device is recalled, the harm is usually widely known. What are really needed are more stringent requirements for reporting all types of harm that might be related to medical devices as soon as they are alleged.

• Giving the U.S. FDA more authority to ensure your safety in regards to medical devices does not necessarily mean that the FDA will use that authority on your behalf.

Because of the limitations of the Act and the weaknesses in its potential effect, our Houston medical device injury lawyers remain somewhat dubious of the real efficacy of this Act. It appears to be more of a window dressing of the safety issues relating to medical devices than an actual, substantive attempt to really address these issues. It’s an election year after all, so chances are that we’ll see more highly-touted, but essentially ineffectual, legislative nods to current issues before the year is out.

As far our Houston medical device injury lawyers can see, your safety from untested medical devices remains at risk. So do your research if you can before accepting any medical device implants or enhancements.