New approval system may shake up medical device industry

Despite the vital role medical devices play in the diagnostic process, issues related to their quality often get buried under the debates over drug safety. It seems the regulators have been too liberal with the medical devices sector, which is expected to grow into a $170-billion industry by next year. However, things will not be the same anymore for the companies making diagnostic devices.

The FDA this week woke up to the realization that the norms currently followed for approving medical devices were set more than 40 years ago. Considering the technological advancements the industry has witnessed since then, the FDA has decided to overhaul the 510(k) approval process so as to keep a tab on the risk factors.

Of late, there has been a spurt in cases of patients getting hurt by unsafe or poorly designed medical devices, which according to the FDA is the consequence of manufacturers not adopting the latest technology. All these years, the prevailing system allowed firms to seek speedy approval of their products if the design is not substantially different from their earlier variants which have already been approved.

Considering the technological advancements, the FDA has decided to overhaul the decades-old 510(k) approval process

Here, the regulators are invariably comparing a product with its predecessor that uses technology that is obsolete. The latest move is expected to pave the way for more advanced medical devices hitting the market while minimizing the risks involved in their usage. An alternative accelerated pathway, based on a new set of guidelines, is expected to come into effect by next year.

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Recently, the FDA drew criticism from a media group for fast-tracking the approval process for medical devices, which according to a study conducted by the team compromised on safety and left several patients injured. The planned revision includes publication of the details of devices that are more than ten years old and the names of their manufacturers. Under the new system, clinical tests will be mandatory for sanctioning new devices.

Meanwhile, there are concerns that the 10-year cut-off would make the data contained in the older predicates inaccessible to manufacturers and researchers, thereby reducing the scope for innovation.

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