A Look at Medical Device Numbers in 2011

The medical device market is facing a number of hurdles, which are having a negative influence on job growth, the funding climate, and the industry’s overall prognosis.

November 22, 2011

2 Min Read
A Look at Medical Device Numbers in 2011

FDA reported510(k) Review time(Office of DeviceEvaluation, AnnualPerformanceReport, 2009)

US companies’Experience with510(k) Review

US Companies’Experience inEurope (CE)

FDA Reported PMAReview Time(Office of DeviceEvaluation, AnnualPerformanceReport, 2009)

US companies’experience withPMA review

US companies’experience inEurope (CE)

3 months“average totalelapsed timefrom receipt tofinal decision”

10 months fromfirst filing toclearance31 months fromfirst communicationto clearance

7 monthsfrom firstcommunicationto certificate

9 months“average totalelapsed timefrom filing toapproval for alloriginal PMAs”

54 monthsfrom firstcommunicationto approval (orto present)

11 monthsfrom firstcommunicationto certificate

Source: FDA Impact on U.S. Medical Technology Innovation

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