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,, 12 November 2012

Back to Listings

WhichMedicalDevice is a FREE resource created by clinicians for clinicians.

Registration is free and gives you unlimited access to all of the content and features of this website.

Find out more...

Please sign in to view this content...

I have forgotten my password
Not a Member?

Registration is free and gives you unlimited access to all of the content and features of Which Medical Device. Find out more...

Why Register

Which Medical Device is a community of clinicians sharing knowledge and experience of the devices and procedures we use on a daily basis. We ask that our members register with us so that we can maintain the unbiased and independent nature of our content. Registration is quick and free.

We do not make your details available to any third parties nor do we send unsolicited emails to our members. You can read our Privacy Policy here.