Interesting Survey Results on the FDA's Process
Published date : 14 November 2012
Article date : 14 November 2012
Medcitynews reports on a survey commissioned by the MedTech Resource Alliance that invited 2707 medical device manufacturers to share their experiences of the FDA’s 510(k) pathway. Of the 129 companies that responded, 64% indicated that they are either “extremely dissatisfied” or “somewhat dissatisfied.” The groups that report the highest dissatisfaction are ophthalmic, neurological and ENT device companies. Those with the highest satisfaction manufacture cardiovascular devices, infection-control and dental devices and devices for anesthesiology and hospitals.
Apparently, the main reason for dissatisfaction is a delay in communication, especially if the FDA ultimately ruled that a product could not be cleared because it wasn’t substantially equivalent to a product currently available in the market.
The article goes on to say that another area of concern is what device makers perceive as 'a lack of scientific expertise' at the FDA.
Read the full article here.
Read the survey report here.
Source: Arundhati Parmar, Medcitynews.com, 12 November 2012
