President of Dynatronics Corp. and Medical Device Manufacturers Association Board Member Kelvyn Cullimore has testified on the FDA Globalization Act. The hearing, held by the House Energy and Commerce, Subcommittee on Health, highlights the Committee's efforts to push legislation which would create additional user fees for manufactures and increase the number of pre-approval inspections in foreign and domestic facilities. On behalf of MDMA, Cullimore expressed several concerns. For instance, he cited that the current legislation would require manufacturers pay additional and overly-burdensome user fees, despite the fact that the industry just recently agreed to double the amount of fees paid under the Food and Drug Administration Amendments Act of 2007.

He also suggested the legislation would delay access to innovative and life-saving medical technologies by requiring preapproval inspections for products regardless of risk level.

In separate announcements, small companies say the paperwork and requirements of the Globalization Act would put them out of business.