Categories Analysis, U.S. Markets News

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Here, the regulators are invariably comparing a product with its predecessor that uses technology that is obsolete.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.

FDA adds restrictions on sale of e-cigarettes

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.

 

Get access to timely and accurate verbatim transcripts that are published within hours of the event

Most Popular

What to look for when CVS Health (CVS) reports Q3 earnings

Healthcare company CVS Health Corporation (NYSE: CVS) is all set to report earnings next week, with Wall Street expecting a mixed outcome. The company has been facing challenges in certain

eBay (EBAY): A few factors that helped drive growth in Q3 2024

Shares of eBay Inc. (NASDAQ: EBAY) stayed green on Friday. The stock has gained 32% year-to-date. The ecommerce leader delivered revenue and earnings growth for the third quarter of 2024,

CVX Earnings: Chevron reports lower revenue and profit for Q3 2024

Energy exploration company Chevron Corporation (NYSE: CVX) on Friday announced third-quarter 2024 financial results, reporting a decline in net profit and revenues. Net income attributable to Chevron Corporation dropped to

Add Comment
Loading...
Cancel
Viewing Highlight
Loading...
Highlight
Close
Top