Medical Device Link.

NEWS TRENDS

Seven of the 13 Office of Regulatory Affairs (ORA) field labs that FDA planned on consolidating will remain open for the time being. Much to the dismay of many lawmakers, FDA had planned to merge several facilities across the country into five multi­purpose labs to make better use of space and allow for modern research equipment.

Although most of the attention to the lab closings has been in light of the various problems related to food safety and import issues, ORA field labs also inspect and analyze medical devices.

In August, FDA’s Margaret Glavin, associate commissioner for regulatory affairs, told agency staff in a letter that the lab closings would need to be reconsidered, given the import challenges that FDA is facing.

The House of Representatives took its own measures to prevent the closing of the field labs. An amendment to the Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act of 2008 (H.R. 3161) prohibits funds in the act from being used to close or consolidate any of the 13 field labs or 20 district offices. The House adopted the amendment in August.

There have been conflicting reports over whether the announcement to keep the labs open is a permanent decision. According to FDA spokeswoman Julie Zawisza, the plan to keep the labs open is temporary. However, this doesn’t mean that all of the labs will definitely be closing at some point.

“The plans to restructure our field operations, including the lab closures and consolidation, are temporarily suspended so we [FDA] can rethink the best way to proceed,” says Zawisza. “The plan is to proceed with something but [we] don’t know how that looks yet. We know we need to modernize the field operations but need to incorporate and reflect whatever comes out of the president’s import working group as well as our own reevaluation.” In July, President Bush issued an executive order to establish an inter­agency working group on import safety.