The U.S. Food and Drug Administration (FDA) addressed the forthcoming donor eligibility and suitability guidance in a notice published in the Federal Register on August 24th titled “Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice for Blood and Blood Components and Reducing the Risk of Transfusion-Transmitted Infections.”
In the notice, the agency states, “[w]e are revising the information collection to support implementation of annual reporting to FDA of the release of unsuitable blood donations from establishments that intend for their activities to fall under the compliance policy set forth in the draft donor eligibility and suitability guidance for industry entitled ‘Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements’ (May 2022)…Specifically, under [the donor eligibility and suitability guidance], when finalized, when the donation is otherwise suitable under § 630.30(a), FDA does not intend to take regulatory action if blood establishments release donations for transfusion or further manufacture when the review of records, required after donation under § 630.30(a)(2), identifies the donation as unsuitable because of inadvertent failure to follow procedures to ensure that the donation would not adversely affect the health of the donor.”
The FDA explained that it received six comment letters during the comment period for the donor eligibility and suitability guidance. The agency clarified whether “post-donation information (PDI) related to blood pressure, pulse, weight, and red blood cell loss would need to be investigated and reported to us in the report on an annual basis.” In its response the FDA said, “PDI is information received by the blood establishment after donation from the donor or another source that is out of the control of the establishments. We do not consider the receipt of PDI to be an error that must be reported to FDA on an annual basis as described in the guidance. However, the blood establishment’s measurement of a donor’s blood pressure, pulse or red blood cell loss are in the control of the establishment, and errors in such measurement would not be identified through PDI. We have considered the comment and have determined that the comment does not present information that would warrant changes to the guidance document at this time.”
An additional comment in response to the donor eligibility and suitability guidance asked that “the annual report not include corrective actions taken for each error because this would represent duplication of information already available to FDA via its inspection compliance program…The comment further noted that FDA should not request this report because the information can be reviewed during FDA’s inspection compliance program.”
The FDA responded that, “[w]e disagree that including a summary of corrective actions on the annual report would represent duplication of information. Establishments may submit the information already developed as part of their deviation management and corrective action program. A new investigation does not need to be completed and new documentation does not need to be created. Receiving annual information about the corrective actions taken will allow us to better assess the robustness of the establishment’s GMP system in a timely manner. We also note that blood establishments may elect not to use the enforcement discretion provided in the guidance to release certain unsuitable blood components, and therefore, would not submit a report to FDA. Comments are being considered as the guidance is being finalized. We are clarifying in the final guidance that the annual report about the corrective actions taken may be submitted in summary format. This change in wording did not affect our estimate of the burden.” The updated version of donor eligibility and suitability guidance is expected to be published later this year.