FDA would report on how it is meeting these performance goals on a quarterly basis.
Small Business Relief

Small businesses-a significant portion of device manufacturers-would see additional benefits under the proposal. The fees currently paid by businesses with $100 million or less in annual sales or receipts would be reduced from 80 percent of the full fee in the first device user fee program to 50 percent for 510(k) applications, and from 38 percent to 25 percent for pre-market approvals and related supplement fees. FDA would continue to waive the fee for all first-time pre-market approval applications for businesses with $30 million or less in annual sales or receipts. In addition, the proposal would allow a mechanism for foreign businesses to qualify as small businesses.

Greater Transparency

To achieve greater transparency, FDA would continue to foster interactive review by encouraging informal communication with companies; facilitate the timely scheduling of informal and formal meetings; expand the kinds of performance information FDA makes available to the public; enhance opportunities for stakeholders to provide input into guidance document development; facilitate the development of guidance to streamline the processes and to clarify the data requirements for the approval or clearance of imaging devices that use contrast agents or radiopharmaceuticals.
Accredited Third Party Inspection Program

The proposal would streamline the third party inspection program, which allows for the use of accredited private sector auditors for routine inspections, by making it easier for manufacturers to participate in the program. Such inspections augment rather than substitute for FDA oversight and facilitate FDA's ability to allocate its inspectional resources based on risk.
In Vitro Diagnostic Devices

MDUFMA II would foster the development of innovative in vitro diagnostic tests by issuing new industry guidance on important emerging issues and reviewing some low-risk devices to determine whether any of them could be exempted from the need for product review. In addition, FDA would conduct a pilot program under which the agency would review simultaneously a company's 510(k) and waiver applications under the Clinical Laboratory Improvement Amendments, the law that governs quality standards for all laboratory testing.

A notice is on display in today's Federal Register. The public meeting where FDA will present its MDUFMA II proposal will be held at 5630 Fishers Lane, Room 1066, Rockville, Md. After all public comments are evaluated and any appropriate changes made, a final proposal will be submitted to Congress. MDUFMA reauthorization would go into effect only after enacted by Congress and signed by the President.

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