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MeDSuN Pilot Funding Included In Budget; Program To Begin In Six Months

This article was originally published in The Gray Sheet

Executive Summary

Funded at $1.7 mil. in FDA's FY 2001 budget, the Medical Device Surveillance Network (MeDSuN) reporting system pilot is expected to become operational within six months, according to Center for Devices and Radiological Health Office of Surveillance and Biometrics Deputy Director Susan Gardner.

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CDRH appropriations

$165.2 mil. is appropriated for FDA's Center for Devices and Radiological Health and for related field activities under the Agriculture Appropriations Conference Report for fiscal 2001, adopted by the House on Oct. 11. The Senate is expected to vote on the measure the week of Oct. 16. The amount represents a $22.9 mil. increase over the fiscal 2000 level for premarket review. CDRH's total budget carries a $10.5 mil. increase over funding levels for 2000. Of that increase, $7.7 mil. is earmarked for premarket review activities, according to the trade group AdvaMed. The legislation also prohibits FDA from using funds to develop device user-fee programs

SUD Reprocessing Guidance Retains Premarket Exemptions For Now

FDA has not yet decided whether it will retain premarket exemptions for reprocessed Class I/II single-use devices (SUDs), according to the Aug 2 final guidance "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals."

FDA Offers $4,000 To Cover Cost Of Third-Party Review Expenses

FDA would provide the first $4,000 to help companies defray the cost of third-party 510(k) review for eligible devices, the agency explains in its FY 2001 budget justification document.

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