The Digital Pathology Association has established a regulatory committee; the committee goal is to create a sense of urgency within regulatory agencies and to bring clarity to the digital pathology clearance and approval process. 

At Pathology Visions 2011 a Regulatory Panel of experts convened with representatives from the U.S. Food and Drug Administration (FDA), the Centers for Medicaid and Medicare Services (CMS), and the College of American Pathologists (CAP).  The DPA regulatory committee presented a series of questions for the panel to address.  DPA members can view the panel experts presentations and the panel recording “Navigating Digital Pathology’s Path to Patients” within the Member Community

Choose one of categories below:

FDA

CMS/CLIA

CAP

FDA

In the United States, technology manufactured for digital pathology (i.e. scanners, software) are considered medical devices and are regulated by the U.S. Food and Drug Administration (FDA). Manufacturers may market their digital pathology technology for Research Use Only (RUO) unless the FDA has issued a clearance or approval to a specific manufacturer and for an intended use of the digital pathology hardware and software.  Several manufacturers have received one or more FDA 510(k) clearances, however no manufacturer has yet received an FDA approval of their technology for primary diagnosis.
 
The FDA remains focused on the safety and the effectiveness of digital pathology.  Safety is defined in 21 CFR 860.7(d)(1) as the “Reasonable assurance, based on valid scientific evidence, that the probable benefits to health from use of the device for its intended uses and conditions of use, when accompanied by adequate directions and warnings against unsafe use, outweigh any probable risks.”   Effectiveness is defined in 21 CFR 860.7(e)(1) as “Reasonable assurance, based on valid scientific evidence, that in a significant portion of the target population, the use of the device for its intended use and conditions of use, when accompanied by adequate directions for use and warning against unsafe use, will provide clinically significant results.”

In October 2009 the FDA Hematology and Pathology Devices Panel held a meeting to gain expert opinion and industry feedback on the replacement of H&E glass slides and conventional microscopy by whole slide images (WSI), specifically for rendering a routine surgical pathology diagnosis of a disease or condition.  No formal guidance document has been issued by the FDA for digital pathology, however one is expected soon.  In the meantime the FDA has provided two guidance documents, IVD
Diagnostic products Labeled for Research Use Only and Mobile Medical Applications, that are relevant to digital pathology.

EVALUATION OF AUTOMATIC CLASS III DESIGNATION FOR Philips IntelliSite Pathology Solution (PIPS)
Pathology Visions 2011 Presentations (Members Only)
- Regulatory Panel | Navigating Digital Pathology’s Path to Patients (Members Only)
- Digital Pathology 510(k) Clearances
- FDA October 2009 meeting materials and transcriptions
- FDA issued guidance documents relevant to digital pathology
    1. IVD Diagnostic Products Labeled for RUO/IUO
    2. Mobile Medical Applications

CMS/CLIA

Centers for Medicare and Medicaid Services (CMS) oversees the Clinical Laboratory Improvement Amendments (CLIA) which regulate all non research, laboratory tests preformed on humans in the U.S. The goal of CLIA is to insure quality laboratory testing, and therefore quality control (QC) portions of CLIA will apply to digital pathology;  including the analytic phase of testing which requires monitoring the testing personnel, the test system, and the laboratory environment. Other requirements that apply to all testing include calibrations, establishing or verifying performance specifications, test system or equipment maintenance, test results comparisons, corrective actions, having a back-up plan for instrument failure, and a procedure manual.  Validation of a digital pathology system is also necessary, and labs should follow CLIA requirements for test reports.

In February 2012 Clinical Laboratory Improvement Advisory Committee (CLIAC) held a meeting which discussed emerging issues in digital pathology. CLIAC provides scientific and technical advice and guidance to the Secretary of Department of Health and Human Services (HHS); the Assistant Secretary for Health; the Director of Centers for Disease Control and Prevention (CDC); the Commissioner of the Food and Drug Administration (FDA); and the Administrator of the Centers for Medicare and Medicaid Services (CMS). The advice and guidance pertain to general issues related to improvement in clinical laboratory quality and laboratory medicine.  CLIAC may also provide advice and guidance on specific questions related to a possible revision of CLIA standards.

- Validation of Digital Pathology in a Healthcare Environment
- Pathology Visions 2011 Presentations (Members Only)
- Regulatory Panel | Navigating Digital Pathology’s Path to Patients (Members Only)
- Current CLIA Regulations
- Summary of CLIAC February 2012 Meeting

CAP

The College of American Pathologists (CAP) is a CLIA accredited organization composed of board-certified pathologists with a mission to serve patients, pathologists, and the public through the advocation of excellence in pathology and laboratory medicine worldwide.

CAP issues laboratory accreditation checklists which support the accreditation process.  The checklists align with the CLIA mandate of high quality laboratory testing by providing a solid foundation for excellence in patient safety, and compliance with policies, procedures, and laboratory processes.  The Anatomic Pathology, Laboratory General, and Cytopathology checklists have items that can apply to digital pathology systems.  

In 2011 a CAP Center working group was formed to create guidelines for digital pathology.  Thirteen guidelines were developed to assist the pathology community with validating WSI for clinical diagnostic use.  The thirteen guidelines, which are still under development, were presented at Pathology Visions 2011.  The final version of the guidelines has not been issued but is expected soon.  

Download the DPA white paper, Validation of Digital Pathology in a Healthcare Environment, for more specific information about the CAP checklist items and the draft guidelines.

- Ensuring the Future of Digital Pathology (College of American Pathologists Offers First Evidence-Based Guideline for Validating Whole Slide Imaging)
- Validation of Digital Pathology in a Healthcare Environment
- Pathology Visions 2011 Presentations (Members Only)
- Regulatory Panel | Navigating Digital Pathology’s Path to Patients (Members Only)
- The College of American Pathologists' Laboratory Accreditation Program (CAP-LAP) Practical World View on Digital Pathology from a CLIA Accreditation Provider (Members Only)
- Recommendations for Validating Whole Slide Imaging in Pathology: College of American Pathologists (CAP) Pathology and Laboratory Quality Center (Members Only)
- CAP Checklists