FDA Guidance for Vendor Submission in Medical Device Testing

The Word Guidance Is Precise Suggestions, Not Requirements The guidance is not meant to constrain, but to define. Issues & Concerns The FDA Has Encountered Or Believes Are Important Vendors Are Free To Submit Anything They So Desire To make suggestions for why a particular item in the guidance is not necessary To suggest additions to the guidance criteria To ask for clarification. FDA recognizes that as this moves forward, items may be deleted or added to the guidance. FDA is not certain as to what is needed, and is soliciting the opinions of Vendor and others to make suggestions as to what is sufficient in terms of validation, testing, etc. A Separate Guidance Is Anticipated On Clinical Validation Study Design (Overall) Will it be changing from suggestions to requirements after define the guidance? If so, what is the time frame for this process?

General Approach Description What Role A Component Plays In the System Test Methods Method Of Evaluation Of Performance Characteristics Stability/Reproducibility For Each entry, the vendor will have to submit the following information: What is being used to meet the guidance topic. Characterize the method/hardware/software that is being used. How is this characterization tested (How do you know that it does what you say it does) Can you reproduce the tested characterization? How do you reproduce/test it? How do you know that you have tested it sufficiently (robust result)? Statistical evaluation. (Overall, especially sensor, algorithm ) Confidential information in techniques is included in this guidance. Is information controlled with very high confidentiality and strictly within FDA? No disclose to others (in public), correct?

IV (A) Description & Test Methods For Each Component 1 Slide Feeder No dropped or damaged slides Robust error handling 2 Light Source Coverage Stability 3 Imaging Optics 4 Mechanical Scanner Movement Detection Of Errors IV(A)(4)(a) Stage means the plate to place slides? What is purpose of the stage material information? IV(A)(4)(a) Please explain more about Localization and reading of bar code labels in Method of movement of the stage because we don t understand well about the meaning of this.

IV (A) Description & Test Methods For Each Component 5 Digital Image Sensor IV(A)(5) Generally speaking, spectral transmittance of color filter mask is not disclosed. Wish to delete this part. Relative spectral response as a chip is able to provide. IV(A)(5) Regarding readout noise and dark current level, Hamamatsu suggest to remove this part. We suggest to require this for fluorescence imaging only. This guidance should be bright field. 6 Image Processing Software 7 Image Composition 8 Image File Formats

IV (A) Description & Test Methods For Each Component 9 Image Review Manipulation Software 10 Computer Environment 11 Display

IV (B) System-level Assessment 1 Color Reproducibility IV(B)(1)(b). Is there any recommendation slide, commercial available, for color patches? It is unclear that it says transparent test patterns consisting of colors similar to the Gretag Macbeth ColorChecker (24 colors) or X-rite Digital ColorChecker SG (140 colors) 2 Spatial Resolution 3 Focusing Test 4 Whole Slide Tissue Coverage 5 Stitching Error

IV (C) User Interface 1 Description 2 Test methods

Last Bits IV (D) Labeling IV (E) Quality Control