FDA CFR21

by Jim Goldner, President, First Source Inc | September 06, 2005

Jim Goldner
President of First Source Inc. writes:

Subject: FDA CFR21

I am the chairman of the FDA subcommittee for IAMERS' (International Association Of Medical Equipment Remarketers and Servicers).

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We have hired a lobbyist in Washington, D.C. Our objective is to obtain Congressional advice about ways to achieve greater enforcement of existing FDA regulations, which support access to equipment manuals, passwords, and training. We will accomplish this by direct contact with key members of the legislature who we will ask to petition the FDA to enforce existing code regarding Assembly, Installation, Adjustment & Testing (AIAT).

The FDA has promulgated rules that require manufacturers to provide, among other things, adequate instructions and software with each X-Ray and laser product for assembly, installation, adjustment and testing. See 21 C.F.R. 1020.30 (g), 21 C.F.R. 1040, 21 C.F.R. 820.170 and also the National Fire Protection procedures. Specifically, 21 C.F.R. 820.170(a) provides that manufacturers of devices requiring installation shall distribute or otherwise make available to persons installing said devices installation and inspection instructions and test procedures.

I am putting together a list of anecdotal examples as to how the restriction of manuals and software affects the ability of independent service companys and in house service groups to service any equipment that all AIAT information is not provided.

Please send your information to me via E-mail. Contact me if you want more information or if you want to participate in this project.