Medical device registrants nearly doubled from 11,828 in 2009 to 22,436 in 2010. Part of this change is due to increased awareness of CDRH’s online registration, but that can’t be the only reason. In the wake of the economic recession, relatable technology companies (e.g., automotive) have been adding their expertise to the mix. Despite uncertainty in funding and regulation, the industry is still manufacturing medical devices at an intense rate and the possible return is still alluring to those in harder-hit manufacturing sectors.
 

Registration fees for fiscal year 2011 are $2179. FDA requires that all registration and listing information be submitted electronically, unless a waiver has been granted, per amendments to the Medical Device User Fee Modernization Act. Policy questions can be sent to reglist@cdrh.fda.gov.

FDA-registered medical establishments, with the number of firms and percentages of U.S. total for each state. Includes contract manufacturers, manufacturers, and specification developers. Percentages for each state are rounded to the nearest whole number. Source: CDRH establishment registration database.

Medical export sales by product area, 2003–2008 ($ millions). Source: 2007 Economic Census, based on the North American Industry Classification System.

Revenue growth in the United States by product group, 2008–2009. Source: Ernst & Young's Pulse of the Industry 2010.

SWOT analysis of the U.S. medical device market. Source: Espicom Medical Device Market Intelligence Report, Q3 2010.

Medical device user fees for FY 2011. Source: CDRH.

The schedule of registration fees. Source: CDRH.