Congressional Testimony:

• Excerpts from statement of Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, Food and Drug Administration (FDA), before the Committee on Government Reform, House of Representatives on September 26, 2006.  Dr. Schultz' full testimony. 

Testimony submitted to the Senate Health, Education, Labor and Pensions Committee (HELP) for its hearing on reuse, June 27, 2000:

• FDA's Written Testimony, presented by David W. Feigal, M.D., Director of the Center for Devices and Radiological Health, Food and Drug Administration (FDA).

• American Hospital Association's (AHA) Written Testimony (presented by Dr. John Clough of The Cleveland Clinic)

• U.S. General Accounting Office's (GAO) Written Testimony and Report Titled "Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted" (PDF file), presented by Dr. Janet Heinrich, Associate Director, Health Financing and Public Health Issues, GAO

Testimony submitted to the House Energy and Commerce Subcommittee on Oversight and Investigations for their hearing on reuse held February 10, 2000:

• FDA's Written Testimony, presented by David W. Feigal, M.D., Director of the CDRH, FDA
• AHA's Written Testimony, presented by Dr. Walter G. Maurer of The Cleveland Clinic

MDUFMA / MDUFSA Summary:

Summary of the Medical Device User Fee and Modernization Act (MDUFMA) of 2002 and Medical Device User Fee Stabilization Act (MDUFSA) of 2005 Reprocessing Provisions

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), and Medical Device User Fee Stabilization Act of 2005 were signed into law on October 26, 2002, and August 1, 2005, respectively.[1] Although reprocessors of “single use” devices (SUDs) were already subject to the same regulatory requirements as original equipment manufacturers (OEMs), intense pressure from OEMs led to the inclusion of provisions in MDUFMA and MDUFSA that add additional regulatory requirements for reprocessors.  Although there was no public health rationale for the increased regulation, AMDR ultimately worked with Congress, the Food and Drug Administration (FDA), hospitals, and OEMs to develop the provisions described below.  The highest priority of AMDR’s members is patient safety, and we will take every step necessary ensure the safety and effectiveness of reprocessed devices.  
 
The text below very briefly describes the provisions of MDUFMA and MDUFSA that pertain to reprocessing:
 
Identification of Manufacturer of Medical Devices
Section 301 of MDUFMA originally required all devices (both new and reprocessed) to prominently and conspicuously bear one of the following:  the name of the manufacturer, a generally recognized abbreviation of the name, or a unique and generally recognized symbol identifying the manufacturer.  This requirement was to become effective on April 26, 2004.  However, on August 1, 2005, Congress passed MDUFSA and, bowing to OEM pressure, altered the device marking provisions to apply only to reprocessors and no longer to OEMs.[2]
 
Required Statements on Labeling
MDUFMA required the labeling of reprocessed devices to prominently and conspicuously bear the statement, "Reprocessed device for single use. Reprocessed by [name of the reprocessor]." This provision took effect January 26, 2004.
 
Premarket Notification - Validation Data
As part of MDUFMA, FDA was required to evaluate devices for which premarket submissions (known as “510(k) submissions” or, simply, “510(k)s”) are required, to determine which of those devices, when reprocessed, would henceforth be subject to the additional requirement that the 510(k) include data validating that the devices, after reprocessing, would be clean, sterile and functional.  On April 30, 2003, the agency published a list in the Federal Register of devices that would require validation data.[3]  Reprocessors have complied with this requirement.
 
Premarket Notification - Exempt Devices
There are many devices that, when manufactured by an original equipment manufacturer, are exempt from the 510(k) requirement.  Under MDUFMA, FDA was required to review the list of exempt devices that met a new statutory definition of “critical” or “semi-critical” and to determine which ones, when reprocessed, would henceforth require a 510(k).  Specifically, FDA was to terminate the 510(k) exemptions for reprocessed devices in cases where the agency determined a 510(k) is necessary “in order to provide a reasonable assurance of the safety and effectiveness of the devices.”[6]  On April 30, 2003, FDA published a list in the Federal Register of the “critical” devices for which exemptions were terminated,[see 3] and on April 13, 2004, published a list of the “semi-critical” devices for which exemptions were terminated.[7]
 
For those devices whose exemptions were terminated, reprocessors had 15 months from the publication of the list (by July 26, 2004 for critical devices and July 13, 2005 for semi-critical devices) to submit a 510(k).  Reprocessors have complied with this requirement.
 
MedWatch
Finally, MDUFMA required FDA to modify the mandatory and voluntary MedWatch forms to include boxes indicating whether a device was a reprocessed “single-use” device and the name of the reprocessor. FDA revised the forms in February of 2004.[8] 
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[1] Medical Device User Fee and Modernization Act of 2002, Pub. L. No. 107-250, 116 Stat. 1588 (codified as amended in scattered sections of 21 U.S.C) [hereinafter MDUFMA]; Medical Device User Fee Stabilization Act of 2005, Pub. L. No. 109-43, 119. Stat. 439 (codified as amended in 21 U.S.C. 352(u) [hereinafter MDUFSA].  

[2] See MDUFSA.
[3] 68 Fed. Reg. 23139 (April 30, 2003).  See also, 68 Fed. Reg. 38071 (June 26, 2003).
[4] MDUFMA Sec. 302(b).

[5] Guidance for Industry and FDA Staff; Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions [510(k)s] for Reprocessed Single-Use Medical Devices, 68 Fed. Reg. 40679 (July 8, 2003).

[6] MDUFMA Sec. 302(b).

[7] 69 Fed. Reg. 19433 (April 13, 2004).

[8] 69 Fed. Reg. 7490 (February 17, 2004).

For FDA's MDUFMA web-site, please click here.