Medical Electronic Devices: Dealing with FDA Approval

Medical electronic devices have advanced greatly in recent years and the United States Food and Drugs Administration (FDA) has increased its regulation in line with this.

There has also been talk of extending the type of electronic medical devices being covered by FDA regulations.

The Gray Sheet previously reported that there could be an argument made for electronic health records being classed under medical devices as the technology becomes ever more sophisticated.

Sharona Hoffman, a law and bioethics professor at Case Western Report University, told the news provider: "There has to be recognition that these need to be regulated. They are more than just a data entry product. If they fail, patient care fails."

Some software types are already considered to be medical devices and if such regulations were to be extended it would mean more pharma technology companies would be required to deal with the FDA.

At the same time as these developments are taking place, there are those who argue the process for approving medical devices is already too burdensome and could be affecting the growth of the industry.

Cost of documentation for FDA approval

A recent report by Stanford University found almost three-quarters of the cost for medical device manufacturers in the United States to bring a product to market was spent on regulatory submissions.

Entitled the FDA Impact on US  Medical Technology Innovation, and supported by Medical Device Manufacturers Association and the National Venture Capital, it issued an evaluation of the current system for regulatory submissions as "unpredictable, inefficient, and expensive".

The average cost of bringing a 510(k) – or premarket notification – product to market was placed at $31 million (£19.8 million), with 77 percent of this going on the FDA approval project. Medical devices considered to be high risk cost $94 million to take to market, with 80 per cent of this being spent on FDA approval linked activities.

The figures serve to demonstrate the importance of ensuring an efficient system for collating documentation for submission for FDA approval.

According to the report, this is having an impact on a number of areas of the pharmaceutical industry, specifically those developing medical devices for use within the fields of orthopaedics, cardiovascular health and spinal injuries.

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