FDA includes Remanufacturers of Medical Single-Use Devices in cGMP Rules

In Vol. 75, No. 121 of the Federal Register, the FDA announced the inclusion of remanufacturers of hospital single-use devices in the cGMP/QS rules (21 CFR 820). The FDA intends to bind the remanufacturers fully to the cGMP/QS rules: "In addition, remanufacturers of
hospital single-use devices (SUDs) will now be considered to have the same requirements as manufacturers in regard to this regulation."

The FDA stresses that, by including the remanufacturers in cGMP/QS, it hopes for a better design control in the future resulting in a correspondingly lower number of design-related deficiencies. In the past, design-related deficiencies led in part to serious injuries, in some cases even to death. The document calculates the additional cost that is to be expected for the remanufacturers due to the inclusion in cGMP/QS. The basis for these calculations were the considerations that were already calculated during the revision of 21 CFR 820 in 1996.

On balance one can say that the inclusion of remanufacturers in cGMP/QS is a reasonable progress, and it is to be hoped that it will not only reduce failures due to design deficiencies strikingly.

Comments on the above announcement can be handed in until 23 August 2010. The complete document, which also reflects the complete contents of 21 CFR 820 once more, can be found here.

Sven Pommeranz
On behalf of the European Compliance Academy (ECA )

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