Count of first-time medtech approvals granted by FDA 2006-2017

This statistic displays the number of medtech first-time approvals (including PMAs/HDEs/PDPs - PMA: pre-market approval; HDE: humanitarian device excemption; PDP: product development protocol) granted by the FDA (Food and Drug Administration) per year from 2006 to 2017. In 2008 there were 30 first new PMAs/HDEs/PDPs. A PMA is a process undertaken by the FDA in the United States, to review and evaluate the safety and effectiveness of Class III medical devices. A traditional PMA application requires large volumes of information to be submitted such as device description and intended use, clinical studies, and labeling.

Number of medtech first-time approvals (PMA/HDE/PDP) granted by the FDA per year from 2006 to 2017*

Number of approvals
--
--
--
--
--
--
--
--
--
--
--
--
Exclusive Premium statistic

You need a Premium Account for unlimited access.

  • Full access to 1m statistics

  • Incl. source references

  • Available to download in PNG, PDF, XLS format

Premium Account

only $59 / month *
*Duration: 12 months, billed annually, single license

Access to this and all other statistics on 80,000 topics from

$708 / Year

Show detailed source information?
Register for free
Already a member?
Log in
Sources

Release date

September 2018

Region

Worldwide

Survey time period

2006 to 2017

Supplementary notes

* PMA: pre-market approval; HDE: humanitarian device excemption; PDP: product development protocol.
** Added from previous editions of this report.

Statista Accounts: Access All Statistics. Starting from $708 / Year
Basic Account
Get to know the platform

You only have access to basic statistics.
This statistic is not included in your account!

Premium Account
Your perfect start with Statista
  • Instant access to 1m statistics
  • Download in XLS, PDF & PNG format
  • Detailed references

$59 / Month *

Corporate Account
Full access

Corporate solution including all features.

* All products require an annual contract.
   Prices do not include sales tax.

Statistics on "Pharmaceutical trends in Europe"

Statista Accounts: Access All Statistics. Starting from $708 / Year
Learn more about how Statista can support your business.