Will a new FDA user fee discourage innovation in medical devices ?

More medical device companies have been using an alternative pathway to get innovative products on the market faster, but a new user fee on industry could affect the use of this pathway.

The “de novo” classification pathway has been used to get devices on the U.S. market such as Accelerate Diagnostics Inc.'s PhenoTest BC Kit, the first test to identify organisms that cause bloodstream infections and provide information on the correct antibiotics for treatment. De novo is a way to get products on the market without going through the Food and Drug Administration’s most stringent review process, known as premarket approval.

However, if companies have to pay a new fee that is seen as relatively burdensome, it could dissuade applicants from seeking de novo classification...

Latest news

How to Keep Up with FDA’s Expanding UDI Requirements

September 2018 brings a new deadline. Here’s what medical device manufacturers need to do. Patient safety doesn’t just lie in the hands of doctors and nurses. Medical devices and surgical instruments also have a huge impact on the accuracy of diagnostics and the proper execution of treatment plans. The reliability of devices used to treat or diagnose patients can be a matter of life or death, and flaws might not become apparent until it’s too late. Traceability systems using unique product identifiers have proven to be a highly effective means of helping protect the public from faulty devices...

International -
Amazon Is Building an All-Star Health Tech Team

Amazon has reportedly hooked a former FDA officer for its new healthcare business, but we still don't know much about this secretive new venture. Details about Amazon's ambitions in healthcare are still sparse at this point, but the online retail giant appears to be building an all-star team to lead the new venture. Earlier this year Amazon announced a partnership with Berkshire Hathaway and JPMorgan Chase to create a new venture aimed at lowering healthcare costs and improving quality for employees. The company is also reportedly looking to give traditional medical suppliers a run for their...

International -
Johnson & Johnson Could Pull Plug on LifeScan

Johnson & Johnson continues its exodus from the diabetes market and has received a $2.1B offer from Platinum Equity to acquire LifeScan. Johnson & Johnson is getting closer to exiting the diabetes market, as Platinum Equity has made an offer to acquire the New Brunswick, NJ-based firm’s LifeScan unit for $2.1 billion. LifeScan develops blood glucose monitoring products and earned $1.5 billion in revenue in 2017. During J&J's most recent earnings call, company executives pointed to both diabetes and orthopedics as two units that had lagging sales. “Orthopedics performance was below...



Make sure you don't miss latest news, stay tuned!