Medical Device + Diagnostic Industry (MDDI) just released the results of a survey which asks the question: What regulations or processes garner the most concern during an investigational device’s product lifecycle? Top answers included:
• A total of 55% ranked FDA 510(k) submissions as a main concern
- 36% ranked it as their 1st concern
- 19% ranked it as their 2nd concern
• A total of 42% ranked FDA pre-submission process as a main concern
- 21% ranked it as their 1st concern
- 21% ranked it as their 2nd concern
Another question asked to the survey group of 283 people from the industry: What do you think about the medical device industry? The top three concerns included:
• Concerns of FDA or regulatory body interference
• Declining role of Western market leadership
• Perceived safety of medical devices
Interestingly enough, the top distresses do not include the widely publicized Medical Device User Fee Act (MDUFA) which widely affects industry stakeholders. To read about the current status of the MDUFA, check out our blog.
Do you share any of these concerns regarding the medical device industry? Feel free to comment below.
Photo Credit: Purpleslog