MDUFMA small-business guidance now available

FDA's “FY 2008 Medical-Device User Fee Small-Business Qualification and Certification” guidance explains how businesses may qualify as a “small business” and pay most FY 2008 medical-device user fees at substantially discounted rates. If you qualify as a small business, you may also qualify to obtain a one-time waiver of the fee for your first (ever) premarket application (premarket approval application, biologics license application, product development protocol, or premarket report). Read the guidance at www.fda.gov/cdrh/mdufma/guidance/2008.pdf

User fees reduced but new fees added

In September the President signed an act reauthorizing medical-device user fees for fiscal years 2008 to 2012. The FDA will provide updated information at www.fda.gov/cdrh/mdufma/092807-reauthorized.html as updates become available. One change in is the reduction in existing application fees for FY 2008 and the addition of new types of user fees, such as:

1. Submission of a 30-day notice.

2. Submission of a 513(g) request for classification information.

3. An annual fee for periodic reporting on a class III device.

4. An annual fee for the registration of a medical device establishment that is a manufacturer, a single-use device reprocessor, or a specification developer.

5. All medical device establishments must now register and list by electronic means (through the Internet). Annual registration and listing will now take place from October 1 through December 31 of each year.

LXI-equipped products hit $200 million in annual sales

The LXI Consortium says a survey of member manufacturers shows that annual sales of LXI-equipped test and measurement equipment now exceeds $200 million. LXI is a LAN-based standard with capabilities for reducing the time it takes to set up, configure, and debug test systems. LXI also helps integrators use the time and effort already invested in system software and architecture. The standard is managed by the LXI Consortium, a not-for-profit corporation comprised of leading test and measurement companies.

According to the association, this is the fastest ramp-up in sales of any communications standard in the history of the test industry. In addition, the Consortium says more than 419 LXI-equipped products are commercially available, such as switching subsystems, spectrum analyzers, multifunction mainframes, digital multimeters, signal generators, signal analyzers, power supplies, power analyzers, waveform generators, oscilloscopes, and digitizers from such notable manufacturers as Agilent, Xantrex/Elgar, Keithley Instruments, and Pickering Interfaces.