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Requirements for Premarket Submissions: In vitro Diagnostic Instrumentation and Software Related to Donor Screening and HIV Diagnostic Assay Systems Diane Gubernot Scientific Reviewer DETTD/OBRR/CBER. Issue:.

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  1. Requirements for Premarket Submissions:In vitro Diagnostic Instrumentation and Software Related to Donor Screening and HIV Diagnostic Assay SystemsDiane GubernotScientific ReviewerDETTD/OBRR/CBER

  2. Issue: • Software/instruments are becoming increasingly complex due to the development of automated platforms for testing • Some manufacturers have expressed confusion regarding pre-market submission requirements for software related to blood typing, donor screening and HIV diagnostic assay systems

  3. Objectives of this presentation: • To summarize the regulations and guidance documents applicable to the submission of BLAs/PMAs/510(k)s for these software systems • To provide specific information to the manufacturers on the content of submission to expedite the review process

  4. Objectives of this presentation: • To inform manufacturers of the standards for level of concern determination which apply to CBER-regulated donor screening and HIV diagnostic assay systems

  5. Software Development: • Quality System Requirements (QSR), found in 21CFR 820s • General Principles of Software Validation; Final Guidance for Industry and FDA Staff (available at www.fda.gov/cdrh)

  6. When Submitting Software/Instrument Applications to CBER: • Manufacturers should follow the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 29, 1998. (available at www.fda.gov/cdrh) • In addition: Manufacturers of blood bank software should follow Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer Software - 1/13/1997(available at www.fda.gov/cber/).

  7. Applications: • Premarket Notifications (510(k)s) • Premarket Approval Applications (PMAs) • Biologic License Applications (BLAs)

  8. Blood Bank & HIV Diagnostic Instrument/Software Devices may be: • Stand-alone software • Software that is used in conjunction with automated instruments • Automated & semi-automated instruments containing firmware • Accessories (e.g. barcode scanners) that interface with any of the above devices

  9. The Guidance for Premarket Submissions includes: • Definitions for Major, Moderate, and Minor Level of Concern • A flowchart for determining the Level of Concern for your device • Required documents to be submitted based on the Level of Concern determination

  10. Level of Concern • Level of Concern is a term used by FDA and industry to determine which software design documents are required to be submitted in an application. • The required verification, validation and testing activities performed by a firm are not limited to the scope of the application submission.

  11. Major Level Operation of the software associated with device function directly affects the patient so that failures or latent flaws could result in death or serious injury, or indirectly affects the patient such that incorrect or delayed information could result in death or serious injury of the patient.

  12. Moderate Level • Operation of the software associated with device function directly affects the patient so that failures or latent flaws could result in non-serious injury, or indirectly affects the patient such that incorrect or delayed information could result in non-serious injury of the patient.

  13. Minor Level • Failures or latent design flaws would not be expected to result in any injury to the patient.

  14. Figure 2: Determining Level of Concern

  15. HIV Diagnostic Instruments and Software: • FDA has determined these to be a Major Level of Concern. • Devices that diagnose, monitor (viral load assays) or genotype HIV (resistance assays) meet the 21CFR809.3 definition of an in vitro diagnostic device. • Incorrect test results from use of the devices could mislead physicians regarding treatment decisions, resulting in serious injury.

  16. Summary: • All software/instrument systems, regardless of the determined Level of Concern, must follow the QSR for system development. General Principles of Validation Guidance document should also be referenced. • The Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices should be followed to expedite the review process. • Seek guidance from CBER prior to submitting an application.

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