FDA Presentation 07/17/07
- 1. VistA Imaging The Regulatory Environment Daniel Carozza, MD RAC 17 July 2007
- 2. Overview – Today’s FDA Regulation FDA’s role in Protecting the Public Health Classification of Imaging Products Quality System Requirements Safety – Process Control Complaint Handling, Tracking, & Reporting Inspection and Enforcement Test Agreements
- 3. General Concepts Congressional Mandate to Ensure Safe and Effective Devices Prior to their distribution
- 4. General Concepts Scope of the Health-Related Manufacturing Industry US Sales exceed 1 Trillion USD Over 80,000 brands and models of devices Over 24,000 registered manufacturers Greater than 25,000 device related submissions per year 400, 000 problem reports/year
- 5. The FDA Concepts guiding FDA device regulation Laws providing the FDA with regulatory authority Structure of the FDA How devices are approved for marketing
- 6. History of Medical Device Regulation Food and Drug Act (1906) Food Drug and Cosmetic Act (1938) New Drug Amendments (1962) Medical Device Amendments of 1976 Safe Medical Devices Act of 1990 Medical Device Amendments (1992) FDAMA – FDA Modernization Act (1997)
- 7. Organization of the FDA General Organization 8 FDA Centers CDRH – Center for Devices and Radiological Health
- 8. Device Classification Class I Class II Class III Humanitarian Devices Custom Devices Emergency Devices Investigational Devices
- 9. Definition – Medical Device … an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is: - intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animal,…. Misconception : “not for diagnostic use”
- 10. Class I Devices General Controls Establishment Registration Device Listing Premarket Notification Exempted Devices (Imaging) - Postmarketing Surveillance Quality System Requirements
- 11. Class I Devices General Controls Establishment Registration Device Listing Premarket Notification (PMN) Quality
- 12. Class I Devices General Controls ensure that product is pure and safe Labeling shall be informative and not misleading Include requirements for premarket notification, QSRs, registration and listing, restrictions on use, records, reporting.
- 13. Class II Device General Controls as for Class I Devices Special Controls Performance and Design Standards Postmarketing Surveillance Guidelines Recommendations Other Actions as deemed needed by FDA
- 14. Class III Devices General Controls Premarket Approval (PMA)
- 15. Humanitarian Devices Used in “any disease or condition that occurs so infrequently in the United States that there is no reasonable expectation that a medical device for such diseases or condition will be developed.” (Orphan Drug Act) Often lack commercial support because of the lack of market potential
- 16. FDA Clearance for Marketing PMA Application Premarket Notification or 510(k) Preamendment Devices
- 17. Medical Device Reporting Definition Requirements Imaging
- 18. Tracking Requirements Why How Imaging Products will meet this requirement
- 19. Removals and Corrections Device Safety Corrections, Recalls and Safety
- 20. Postmarket Surveillance Ongoing Quality Control Control throughout life cycle of product
- 21. FDA Recall Authority Enforcement Options Improvement in Care Patient Safety Product Liability Professional Liability
- 22. Quality System Requirement Formerly known as GMP Good Manufacturing Practices Harmonization with ISO Standards 9000 Special FDA provisions for devices Continuous Product Quality Control
- 23. Regulatory Practices Applied to Imaging Usage Agreement & Test Agreements Implementation of Imaging Systems Installation and Installation Resources Local Configuration and Modifications National Training and Education Tracking and Reporting
- 24. Usage Agreement Why is a Usage Agreement Needed in a non-commercial setting Issues that distinguish Imaging from other HIS Products Blood Banking in the DOD Test agreements to meet QSR
- 25. Implementation Process Systems Analysis Design Proposal General and Detailed System Design Procurement Installation Training Evaluation
- 26. Local Configuration & Modifications Configuration of the System must be done by Trained Personnel only ALL other modifications must be done by manufacturer, following the change control procedures required by the QSR
- 27. Local Modifications The Food and Drug Administration classifies this software as a medical device. As such, it may not be changed in any way. Modifications to this software may result in an adulterated medical device under 21 CFR 820, the use of which is considered to be a violation of US Federal Statutes.
- 28. Prescription Use of Imaging Caution: Federal law restricts this device to use by or on the order of either a license practitioner or persons lawfully engaged in the manufacture or distribution of the product.
- 29. Usage and Test Agreements “Property of the US Government. No permission to copy or redistribute this software is given. Use of this software, including unreleased versions, requires the user to execute a written agreement with the DOD Development Office. Contact: 800-555-1234”
- 30. Training & Education Provide the training needs recognized in the Project Implementation Team with Implementation Managers and Technical Services Provide face-to-face Video Conferences, CD ROM, WEB, CBT Essential role in meeting FDA QSR training requirements.
- 31. Tracking and Reporting A Quality Assurance step and QSR mandate Team effort Agreement should list tracking roles & responsibility
- 32. Tracking Requirement Why Device failure Software updates Mandatory Safety Changes Avoidance of Safety Incidents How Imaging Products can meet this requirement Agreement Built-in reporting tools
- 33. Potential Consequences of Misuse Compromised Safety Professional Liability Product Liability FDA recall or other enforcement
- 34. Questions?
- 35. Commercial Components Used by VistA Imaging as of July 2007 AccuSoft ImageGear OCX-32 Pro Gold Version 8.0.4. Copyright © 1996-97, AccuSoft Corporation. Refer to www.accusoft.com for further information about this product. Medical Extension/OCX-32 Version 1.1.40. Copyright © 1997-98, AccuSoft Corporation. Refer to www.accusoft.com for further information about this product. Borland Delphi Professional Version 5.0 build 6.18 Copyright © 1983-1999 Inprise Corporation. Refer to www.inprise.com for further information about this product. Borland Delphi Professional Version 7.0 build 8.1 Copyright © 1983-2002 Borland Software Corporation. Refer to www.borland.com for further information about this product. MUSE API Version 005A and Version 005B build 19990324 Copyright © GE Marquette Medical. Refer to www.gemedicalsystems.com for further information about this product.
- 36. Commercial Components Used by VistA Imaging Matrox ActiveMIL 7.5 – May 14, 2003 Copyright © 2003 by Matrox Electronic Systems Ltd. All rights reserved. Refer to www.matrox.com for further information about this product. Dome Version 4.0.2.3 Copyright © 1996-2000 by DOME. Refer to www.dome.com for further information about this product. SPIN32.OCX (Outrider Systems, Inc.) Originally distributed by Microsoft. Refer to http://msdn.microsoft.com/library/default.asp?url=/library/en-us/dnwsvbs/html/usingactivexcontrolsinvbscript.asp for further information about this product. Admin Control Version 5.0.2134.1 Copyright © 1995-1999 Kodak, Eastman Software, Inc., A Kodak Business. Refer to www.Kodak.com for further information about this product. Edit Control Version 5.0.2195.6601 Copyright © 1995-1999 Kodak, Eastman Software, Inc., A Kodak Business. Refer to www.Kodak.com for further information about this product.
- 37. Commercial Components Used by VistA Imaging RoboHelp HTML x5.0.2 Copyright © Macromedia, Inc. Refer to www.adobe.com for further information about this product. MSM Version 4.4.0 Copyright © InterSystems Corp. Refer to www.intersys.com for further information about this product. Cachè Version 5.0.20 Copyright © InterSystems Corp. Refer to www.intersys.com for further information about this product. Aware Toolkit for Compression and Decompression Version V3.8.0.0 Copyright © 2004 Aware Inc. (starting from patch 51) Refer to www.aware.com for further information about this product. DICOM Toolkit version is currently 2.8.7a Copyright (C) 1999-2006, Laurel Bridge Software, Inc. Refer to www.laurelbridge.com for further information about this product.
- 38. Commercial Components Used by VistA Imaging Vergence Locator version 3.3.1.8907 Copyright © Sentillion Corp. Refer to www.sentillion.com for further information about this product. Shareware software: For the directory watcher shareware refer to http://www.codeproject.com/file/directorychangewatcher.asp , Copyright 2001 by Wes Jones For the NT Service source code, refer to http://www.thecodeproject.com/system/cntservice.asp , Copyright (c) 1998 by PJ Naughter. Addendum for JPEG200 compression toolkit: http://www.aware.com/products/compression/compressionsw.html