2009 MedTech Snapshot: Manufacturing: FDA Outreach Boosts the Number of U.S. Device Firms

In 2007, MD&DI reported that FDA had a little more than 16,000 medical device manufacturing firms in its registration database. Then, over the course of two years, the agency instituted a registration fee and a new electronic registration system. It also got the authority to ensure that companies in the registration database were actually in the medical device field and that they were still operational. Before that, legacy companies did not have to reregister each year.

December 1, 2009

2 Min Read
2009 MedTech Snapshot: Manufacturing: FDA Outreach Boosts the Number of U.S. Device Firms

However, once reregistration was required, the database changed dramatically.

The number of device facilities registered dropped in 2008 by more than 4000. According to Theresa McDonald, chief, regulatory policy and systems branch, such a dramatic change was the result of device firms and FDA getting used to the new system and the new fee structure.

This year, the numbers are closer to what FDA expects, McDonald says. “Many companies didn’t realize right away that they needed to renew the forms. It was part of the learning process for companies—and for us.”

By MD&DI’s count, there are more than 17,200 medical device establishments in the United States and its territories. This is the first year the magazine has included numbers from Puerto Rico, which hosts 131 device firms. McDonald says that in addition to firms getting up to speed with the electronic system, there are also many new device companies that registered in 2009, including initial importers and foreign exporters.

FDA also took steps to remind device establishments of the system via e-mail. “We began to send e-mails to firms over the spring and summer so that they didn’t lose track of the process. We’ve tried to do some outreach.” Those efforts seem to have paid off, and McDonald says she thinks the data are a strong representation of the industry in 2009.

To submit registration and listing submissions, contact FDA via e-mail at [email protected]. For policy questions, contact CDRH at [email protected].

Click images and tables to enlarge:

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

Medical device exports by North American industry classification system categories. Numbers for 2008 were estimated using year-to-date data available. Source: International Trade Administration, U.S. Department of Commerce.

Number of U.S. public and VC-backed private companies by segment with a breakdown of the therapeutic sector. Source: Ernst & Young’s Pulse of the Industry: U.S. Medical Technology Report 2009.

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