The Honorable Tammy Baldwin House of Representatives Washington, D.C. 20515-4902 Dear Ms. Baldwin: This is in response to your letter of March 23, 2006, co-signed by Representative Sherrod Brown, concerning original equipment manufacturerers (OEMs) that reportedly restrict access to information requested by third party technicians for use in the installation of devices subject to performance standards and device manufacturing regulations. Trade associations, including the International Association of Medical Equipment Remanufacturers and Servers (IAMERS) have expressed concern about the Food and Drug Administration's (FDA) follow-up when OEMs do not fulfill information disclosure requirements under applicable Federal regulations for the installation of devices. One regulation, a performance standard, is based on FDA's authority to reduce unnecessary exposure to ionizing radiation produced by diagnostic x-ray systems. The performance standard includes a specific information disclosure provision in Title 21, Code of Federal Regulations (CFR), section 1020:30(g). This regulation requires, upon the request by a third party, the disclosure of information concerning the assembly, installation, adjustment, and testing (AIAT) for each certified component in a diagnostic x-ray system. The disclosure provision extends to any AIAT information that is necessary to ensure adequate and safe installation of a diagnostic x-ray system. If special equipment or software is needed to comply with AIAT provisions, manufacturers should provide such equipment or software so the diagnostic x-ray system can meet Federal performance requirements. Another regulation, the Quality System regulation that applies to the manufacture of devices, requires that OEMs establish installation and inspection instructions for marketed devices, and where appropriate, test procedures. OEMs are required to make such information available to person(s) installing the device to ensure the installation is performed according to the manufacturer's instructions, regardless of whether the installer is employed by or otherwise affiliated with the manufacturer (21 CFR § 820.170[b]). Complaints or inquiries regarding the information disclosure requirements for diagnostic x-ray systems may be directed to Thomas M. Jakub at 240-276-3291. For devices that require installation information, Casper E. Uldriks may be contacted at 240-276-0106. We can assure you that we will follow up appropriately to ensure compliance with FDA's applicable information disclosure requirements. Thank you for contacting us regarding this matter. We hope this adequately addresses your concerns. A similar letter has been sent to Representative Brown. Sincerely, David W. Boyer Assistant comissioner     for Legislation