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Health implications could come from new FDA proposal for devices

For residents of Ohio who need medical assistance with a medical device, the possibility that they will be caught up in an issue with defective medical devices should always be in the back of their minds. While these devices are used to help people, that does not mean they are foolproof. A strategy that manufacturers, regulatory agencies and medical professionals use is testing and research. However, a new tack being taken by the U.S. Food and Drug Administration could serve to put people at risk due to the lack of information for newer devices.

A proposal from the FDA will implement a fast track to put some medical devices on the market in a more rapid fashion. With that, there is a possibility that the safety data needed for approval will be reduced. The commissioner of the FDA wrote about the proposal on the agency's website. If it goes through, companies will save millions of dollars that would otherwise have been earmarked for testing and development will move faster.

There is a fast track that the FDA uses now - the 510(k) pathway - but some companies do not reach the criteria to use it. To use 510(k), the product is required to be considered a moderate risk and near a device that is already in existence. For higher-risk devices, the testing procedures and approval process is more difficult. When there is not a device that is considered close to the equivalent of the new device, the commissioner believes that it can hinder innovation. The new strategy would involve performance standards and guidance documents before approval. Safety data and issues with the devices would be assessed after they are on the market rather than before. The idea is to give patients the devices faster. Some medical professionals are concerned that patients would essentially be used to test these devices after they are on the market, leading to danger.

People who need these devices or devices that are already on the market might not take into consideration all the testing that must be done before it is available and deemed safe. Taking away layers of the safety protocol could place people at risk. Health implications, consumer injury, worsened medical condition and death are all consequences of defective medical devices. Those who believe they or a loved one have been damaged by these devices should be aware of their right to seek compensation in a lawsuit. A lawyer can help.

Source:, "FDA proposes new fast path to market for certain medical devices," Toni Clarke, Dec. 11, 2017

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