Survey: FDA 510(k) Submissions Garner Most Concern Among Device Professionals

Posted 16 March 2012 | By Alexander Gaffney, RAC 

A new survey of medical device professionals conducted by the publication Medical Device and Diagnostic Industry found that 510(k) submissions garner the most concern among all regulatory issues, followed closely by the pre-submission process to the US Food and Drug Administration (FDA).

The survey of 283 medical device professionals asked what two regulations and regulatory processes were of the most concern.

Thirty-six percent of respondents indicated 510(k) submissions gave them the most concern, while 19% of respondents indicated 510(k) submissions as their second choice (55% total).

Coming in a close second was FDA's pre-submission process. Twenty-one percent of respondents indicated it was their first-ranked concern, and an addition 21% said it was their second-ranked concern (42% total).

Runners up included:

  • The Patient Protection and Affordable Care Act - 31% total
  • Regulatory export hurdles - 31% total
  • European regulations - 26% total

The rest of the survey results can be found at the link below.

Read more:

Medical Device and Diagnostic Industry - Medtech Exclusive Survey: Top Regulatory Concerns

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