CBER Medical Device Regulation Presentation

On May 11, 2006 Diane Gubernot of FDA’s Center for Biologics Evaluation and Research gave a presentation entitled: Medical Devices involved in Blood DonorCollection, Processing and Screening and HIV Diagnosis. The slides are at the link provided.

This presentation discusses how systems interfaced to donor screening and transfusion systems are regulated directly, or as accessories to Blood Establishment Computer Systems. It states that transfusion management systems are medical devices. It also presents several options for instrument submissions either as part of a BLA or separately as a PMA.
“Compliance Program Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7341.002”

This guide mentions software and computer systems in one paragraph which is provided below:
“Computers: The performance of computer software must be validated (if customized) or verified (if used “off-the-shelf”) for the intended use if the firm relies upon it to comply with core CGTP requirements. Requirements are outlined in 21 CFR 1271.160(d). If the firm is using a computerized record-keeping/ tracking system, ensure the integrity of records is maintained and traceability of all HCT/Ps from donor to the consignee or final disposition; and from the consignee or final disposition to the donor. ”

Keywords: BECS, Blood Establishment, CBER

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SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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