Monday, September 6, 2010

Do you understand this logic?

Unfortunately I don't subscribe to Devices & Diagnostics Letter, but the excerpt below doesn't make sense! I agree that the current 510(k) process is arbitrary and opaque, but surely that will hurt foreign firms more than US firms, I'd think. What is your opinion?

Lawmakers: Better 510(k) Process Key to Keeping Device Jobs in US
Trying to keep devicemakers, and the jobs they provide, in the U.S., lawmakers are urging the FDA to be more transparent and predictable in its review of 510(k)s. Delays in review times and the agency’s unpredictability in reviewing 510(k)s are hurting U.S. devicemakers trying to compete in the global market, as more countries, including China, require devices to be approved in their home country before granting them marketing authorization. As a result, some devicemakers have moved their headquarters to the EU where they can get more timely marketing approval, Sen. Amy Klobuchar (D-Minn.) said.
Devices & Diagnostics Letter

No comments:

Post a Comment