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

Australia -
Medical devices notices & standards orders

Medical devices notices Therapeutic Goods (Articles that are not Medical Devices) Order No. 2 of 2017 (link is external) Declares that a material or other article that through chemical means is intended to change, or that acts by causing change to, the pH level of body fluids including in a body orifice, is not a medical device for the purposes of the Act Therapeutic Goods (Articles that are not Medical Devices) Order No.1 2017 (link is external) Declares that riboflavin products instilled into the eye(s) that are used in the treatment of disorders of the eye which cause structural changes...

International -
Designing a Device for Drug Delivery? What You Need to Know about Extractables, Leachables, and Particles

Growing demand for drug-delivery devices is bringing the pharmaceutical and medical device industries closer together. The risks posed by particulates and extractables and leachables, for instance, present challenges for both industries, so drug-delivery device designers and their pharma partners are encouraged to take a risk-based approach to testing. Standards bodies and industry groups are already working on guidances to help, but much of the critical thinking is up to the manufacturers themselves...

India -
Introduces price controls for knee implants

India has capped prices of orthopaedic knee implants, in the country's latest move to bring down prices of medical devices. The introduction of price controls marks the latest step by Prime Minister Narendra Modi's government to make drugs and medical devices more affordable. In February, it imposed a 75 percent price cut for certain heart stents - wire mesh tubes used to treat blocked arteries, which caused protests among manufacturers...



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