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Volume one How to Use this service newsletters tab 100: overview of fDa Device Regulation

Executive Summary ............................................... ¶100 Importance of Premarket Notification -- 510(k) .....................................................................¶101 FDA's Postmarket Information Requirements .......¶102 CDRH Current "State of the Union" ........................¶103 CDRH Executive Organizational Chart ..................¶104 CDRH Offices' Organizational Charts ....................¶105 Scope of FDA Regulation of Devices .......................¶110 Products Subject to Regulation ............................... ¶111 Persons Subject to Regulation ................................ ¶112 The Path to the Marketplace ................................. ¶120 Regulatory Classification .........................................¶121 Product Development ...............................................¶122 Registration, Listing and Product Labeling...........¶123 Manufacturing Controls ..........................................¶124 Export and Import Clearances ................................¶125 Role of CDRH's Ombudsman...................................¶126 Obligations After Marketing .................................. ¶130 Reporting of Voluntary Remedial Actions.............. ¶131 Reporting Certification ............................................¶132 Postmarket Surveillance ..........................................¶133 Device Tracking ........................................................¶134 Compliance and Enforcement Remedies .............. ¶140 Administrative Remedies ........................................ ¶141 Judicial Remedies .....................................................¶142 FDA and Other Federal Agencies and Laws........... ¶150 Electronic Product Radiation Control Provision ................................................................ ¶151 Environmental Protection Agency Authorities .....¶152 Centers for Medicare and Medicaid Services........¶153 Federal Trade Commission Authorities .................¶154 Consumer Product Safety Commission Authorities .............................................................¶155 FDA and State Regulation and Preemption........... ¶160 Human Tissue Products.......................................... ¶234 Combination Products........................................... ¶240 Historical Context .....................................................¶241 Statutory Procedures To Regulate Combination Products .........................................¶242 Regulations and Inter-Center Agreements ........... ¶243 Request for Designation of a Combination Product.................................................................. ¶244 Review Times for Combination Products ...............¶245 Disputing the Timeliness of Premarket Reviews of Combination Products..................... ¶246 Postmarket Regulation of Combination Products.................................................................¶247

tab 300: Registration, listing, and labeling Requirements

Executive Summary ............................................... ¶300 Statutory Framework for Registration and Listing ................................................................ ¶310 Establishment Registration and Device Listing Regulations ............................................ ¶320 Who Must Register ...................................................¶321 Devices That Must Be Listed ....................................¶322 Information Required by Listing Regulations............................................................¶323 Obligations of Foreign Establishments and Distributors ........................................................ ¶330 Distributor Reporting and Foreign Establishment Requirements ..............................¶331 Exemptions for Device Establishments ................. ¶340 General Labeling Provisions ................................. ¶350 Representations About Intended Use .....................¶351 Advertising and Promotion .....................................¶352 Labeling of Over-the-Counter Devices ................... ¶360 Content of OTC Device Labels .................................¶361 Adequate Directions For Use...................................¶362 Exemptions From Adequate Directions For Use................................................................ ¶370 Prescription Devices ................................................¶371 Loss of Exemption from Labeling Requirements ........................................................¶372 Other Exemptions .....................................................¶373 Labeling Exemption for Shipping Sterile Devices ...................................................................¶374 Labeling of In Vitro Diagnostic Products.............. ¶380 Content of Label ........................................................¶381 Content of Package Insert ........................................¶382 Use of Symbols for Professional-use In Vitro Diagnostic Products ............................................ ¶383 Labeling Exemptions for In Vitro Diagnostic Devices .............................................. ¶384 Analyte Specific Reagents (ASRs) ......................... ¶385

tab 200: fDa Jurisdiction over Devices

Executive Summary ............................................... ¶200 Definition and Jurisdiction of Combination Products.................................................................¶201 Definition of a Device ............................................ ¶210 FDA Criteria for Device Definition .......................... ¶211 "Intended Use" ..........................................................¶212 Court Interpretations of the FDA's Jurisdiction......................................................... ¶220 FDA's Application of the Device Definition ........... ¶230 Components, Parts, and Accessories......................¶231 Diagnostic and Therapeutic Devices ......................¶232 Computer Products ...................................................¶233

Executive Summary ............................................... ¶400

Tab 400: Classification and Reclassification

Guide to Medical Device Regulation

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Tab 400 (cont'd) The Three Classes of Device ....................................¶401 The Three Methods of Classification ..................... ¶402 Reclassification ........................................................ ¶403 Purpose of Classification ...................................... ¶410 Description of the Device Classes ......................... ¶420 Class I Device Definition .........................................¶421 Class II Device Definition ........................................¶422 Class III Device Definition ......................................¶423 Methods of Classification...................................... ¶430 Classification of Pre-Amendments Devices ..........¶431 Classification of Post-Amendments Devices .........¶432 Classification of Transitional Devices ................... ¶433 Significance of Classification Status .................... ¶440 Purpose of Reclassification ................................... ¶450 Reclassification Procedures .................................. ¶460 Reclassification Petition Contents ..........................¶461 Reclassification of Pre-Amendments Devices.......¶462 Reclassification of Post-Amendments Devices ..... ¶463 Reclassification of Transitional Devices ............... ¶464 Revision of Class III Pre-Amendments and Transitional Device Classifications ................... ¶470 Revision of Pre-Amendments Device Classifications ....................................................... ¶471 Revision of Transitional Device Classifications .......................................................¶472 Classification Revision for Certain Contact Lenses ........................................¶473 Standards for Reclassification .............................. ¶480 The Statute and Regulations ...................................¶481 Case Law for Reclassification ..................................¶482 FDA Approach to Reclassification .......................... ¶483

Responsibilities of Sponsors, Investigators, and IRBs ............................................................. ¶560 IDE Sponsor Responsibilities ..................................¶561 IDE Investigator Responsibilities ............................¶562 Investigator Financial Disclosure .......................... ¶563 IDE Record Keeping, Reporting, and Confidentiality ................................................... ¶570 IDE Record-keeping Requirements ........................¶571 IDE Reporting Requirements ..................................¶572 IDE Confidentiality Regulations .............................¶573 Prohibition on IDE Promotion and Commercializing ................................................ ¶580 IDE Withdrawal ...................................................... ¶590 Investigator Disqualification ...................................¶591

tab 600: Quality systems

Executive Summary ............................................... ¶600 Significance of Design Control Requirements......¶601 Significance of Personnel Requirements ............. ¶602 ISO 13485 Compatibility with the QS Regulation ....................................... ¶603 Quality System Regulation Scope...........................¶610 Who Must Comply with the QS Regulation ........... ¶611 Exclusions or Exemptions from the QS Regulation ............................................................. ¶612 How to Obtain an Exemption or Variance .............¶613 Quality Systems Requirements ............................. ¶620 Management Responsibility....................................¶621 Quality Audits ...........................................................¶622 Personnel Requirements .........................................¶623 Design Controls ..................................................... ¶630 Overview of Design Control Requirements ...........¶631 Design and Development Planning ........................¶632 Design Input and Output ........................................ ¶633 Design Review.......................................................... ¶634 Design Verification and Validation ........................ ¶635 Design Transfer........................................................ ¶636 Design Changes ........................................................¶637 Design History File .................................................. ¶638 Design Controls and Investigational Device Exemptions............................................................¶639 Document Controls ................................................ ¶640 Document Approval and Distribution ....................¶641 Document Changes...................................................¶642 Purchasing, Acceptance and Servicing Activities ............................................................ ¶650 Purchasing Controls.................................................¶651 Acceptance Activities ...............................................¶652 Servicing ................................................................... ¶653 Production and Process Controls ......................... ¶660 Production and Processes .......................................¶661 Inspection, Measuring and Test Equipment..........¶662 Process Validation ................................................... ¶663 Quality System Manufacturing Controls .............. ¶670 Identification and Traceability ................................¶671 Nonconforming Product ..........................................¶672 Labeling and Packaging Controls...........................¶673 Handling and Storage Controls ..............................¶674 Distribution Controls ...............................................¶675

tab 500: Investigational Device exemption -- IDe

Executive Summary ............................................... ¶500 Purpose of Investigational Device Exemptions (IDEs).............................................. ¶510 Statutory Exemption .............................................. ¶520 IDE Regulations ..................................................... ¶530 What Is Covered by IDE Regulations? ....................¶531 Institutional Review Boards (IRBs) ........................¶532 How to Apply for IDEs .............................................. ¶533 Pre-IDE Meetings..................................................... ¶534 Investigations Exempt From IDE Regulation ....... ¶535 Waivers ..................................................................... ¶536 IDE Refuse-to-Accept Policy ....................................¶537 Treatment Use .......................................................... ¶538 Individual Patient Access.........................................¶539 Significant Risk Devices ........................................ ¶540 Significant Risk IDEs................................................¶541 Content of Significant Risk IDE Applications ........¶542 FDA Action on IDE Applications ............................ ¶543 Supplemental IDE Applications ............................. ¶544 Non-significant Risk Devices ................................. ¶550 Non-significant Risk IDEs........................................¶551 Content of IDE Study Proposal ................................¶552 IRB Action on a Study Proposal ............................. ¶553

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Tab 600 (cont'd) Installation Controls.................................................¶676 Statistical Techniques ..............................................¶677 Corrective and Preventive Action ...........................¶678 Record Keeping ..................................................... ¶680 Device Master Record...............................................¶681 Device History Record ..............................................¶682 Quality System Record ............................................ ¶683 Complaint Files ........................................................ ¶684 Compliance Implications ...................................... ¶690 Inspection Authority and Process ..........................¶691 Administrative Actions the FDA Can Take.............¶692 Judicial Enforcement ............................................... ¶693 FDA's Use of Injunctions ......................................... ¶694 Inspections by Accredited Persons........................ ¶695

tab 700: Premarket approval -- PMa

Executive Summary ............................................... ¶700 Confidentiality ..........................................................¶701 Product Development Protocols ..............................¶702 Interactive Reviews ................................................. ¶703 Premarket Approval Applications ......................... ¶710 Medical Device User Fee and Modernization Act of 2002 (MDUFMA)........................................ ¶711 Medical Device User Fee Amendments of 2007 (MDUFMA II) ...............................................¶712 Content Requirements .............................................¶713 Primary Data .............................................................¶714 Other Data Requirements ........................................¶715 Expedited Review .....................................................¶716 Shell/Modular Review .............................................. ¶717 Summary Technical Document (STED) Format .....¶718 Collaboration Meetings............................................ ¶719 PMA Application Process ...................................... ¶720 Filing ..........................................................................¶721 Amendments .............................................................¶722 PMA Supplements ....................................................¶723 Panel Review of Applications and Supplements..........................................................¶724 PMA Checklist for Filing Decision ..........................¶725 FDA's Action on a PMA Application ....................... ¶730 Substantive Review...................................................¶731 Day-100 Meetings .....................................................¶732 Scientific Basis for Approval....................................¶733 Use of PMA Data .......................................................¶734 Inspections ................................................................¶735 Post-approval Requirements ................................. ¶740 Appeal of a PMA Decision ..................................... ¶750 Formal Evidentiary Hearing .................................... ¶751 Expert Advisory Committee Hearing .....................¶752 Dispute Resolution Panel Review ...........................¶753 Confidentiality....................................................... ¶760 PMA Suspension and Withdrawal......................... ¶770 Premarket Reports for Reprocessed Singleuse Devices............................................................¶771 Humanitarian Devices ........................................... ¶780 Criteria for Humanitarian Device Exemption .......¶781

Executive Summary ............................................... ¶800 Predictability of FDA's 510(k) Determinations......¶801 510(k) Paradigm ...................................................... ¶802 Third-party Review and Declarations of Conformity............................................................ ¶803 Purpose of Premarket Notification ....................... ¶810 510(k) as a Classification Procedure...................... ¶811 510(k) as a Safety and Effectiveness Screen .........¶812 Definition of Substantial Equivalence .................. ¶820 Congress's Original Intent.......................................¶821 FDA's Definition in Practice ....................................¶822 "Different Questions" of Safety and Effectiveness .........................................................¶823 Who Must File a Premarket Notification .............. ¶830 Marketers of "New" Devices ....................................¶831 First-time Marketers of Devices..............................¶832 Persons Changing or Modifying Marketed Devices .................................................................. ¶833 What Constitutes a Significant Change or Modification ......................................................... ¶834 Labeling Changes That Necessitate 510(k)s ......... ¶835 Exemptions From Filing 510(k)s ........................... ¶840 Custom Device Exemption.......................................¶841 Distributors and Repackagers Exemption.............¶842 Class I and Class II Exemptions ............................ ¶843 Content of Premarket Notification Submission .... ¶850 Information Required by FDA Regulations ............¶851 Summaries or Statements of Safety and Effectiveness .........................................................¶852 Special Content Requirements for Certain Class III Devices .................................................. ¶853 510(k) Refuse-to-Accept Policy............................... ¶854 The 510(k) Decision-making Process .................... ¶860 Intended Use and Predicate Devices ......................¶861 Technology and Use of Data ....................................¶862 Different Safety and Effectiveness Questions ...... ¶863 Expedited Review of 510(k)s .................................. ¶864 510(k)-Rescission Authority ................................... ¶865 When Marketing May Begin.................................. ¶870 Confidentiality....................................................... ¶880 Significance of Substantial Equivalence Determinations .................................................. ¶890

Tab 800: Premarket Notification -- 510(k)

tab 900: Reporting and tracking Requirements

Executive Summary ............................................... ¶900 MDR Requirements ..................................................¶901 MDR Rule Change.................................................... ¶902 Overview of MDR Requirements ........................... ¶910 The Reporting Process ............................................. ¶911 Written Procedures and Record Keeping ..............¶912 Exemptions from MDR.............................................¶913 Manufacturer and Importer Reporting Requirements ..................................................... ¶920 FDA Criteria for Reportable Information................¶921 Death, Serious Injury and Malfunction Reports ...¶922 30-day Reports ..........................................................¶923

Guide to Medical Device Regulation

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Tab 900 (cont'd) Five-day Reports ........................................................¶924 Supplemental Reports ..............................................¶925 Annual Certification................................................ ¶926 User Facility Reporting Requirements.................. ¶930 Individual Adverse Event Reports ..........................¶931 Annual User Reports ................................................¶932 Distributor Reporting ............................................ ¶940 Postmarket Surveillance ....................................... ¶950 Postmarket Transformation Initiative.....................¶951 Devices Subject to PMS ............................................¶952 Confidentiality of Plans and Data .......................... ¶953 Tracking Requirements ......................................... ¶960 Scope of Tracking......................................................¶961 Devices Subject to Tracking ....................................¶962 Manufacturer Information Requirements ............ ¶963 Distributor Information Requirements ................. ¶964 Record-keeping Requirements .............................. ¶965 Exemption from Requirements ............................. ¶966 Confidentiality ..........................................................¶967 Patients' Rights ........................................................ ¶968 Removals and Corrections..................................... ¶970

Mandatory Notifications ........................................ ¶1121 Safety Alerts ............................................................ ¶1122 Mandatory Recalls ..................................................¶1123 Voluntary Recalls ....................................................¶1124 Voluntary Recall Procedures.................................¶1125 Administrative Civil Penalties .............................¶1130 Administrative Detention .....................................¶1140 Seizures ................................................................¶1150 Injunctions............................................................¶1160 Criminal Prosecution ...........................................¶1170 Misdemeanors ........................................................ ¶1171 Felonies .................................................................... ¶1172 Prosecutions From Criminal Prosecution ........... ¶1173

tab 1200: fDa Device Regulation's Relationship with other federal authorities

Executive Summary ............................................. ¶1200 Electronic Product Radiation Control ..................¶1210 Summary ................................................................. ¶1211 Radiation Control Provision of the FD&C Act and Its Purposes .................................................¶1212 Performance Standards .........................................¶1213 Certification and Initial Reporting Requirements ......................................................¶1214 Inspection, Record-keeping, and Reporting Requirements ......................................................¶1215 Detection and Notification for Non-complying or Defective Products .........................................¶1216 Corrective Action for Defective Products ............. ¶1217 Imported Electronic Products ...............................¶1218 Prohibited Acts and Enforcement ......................... ¶1219 Environmental Protection Agency Authorities ... ¶1220 The Centers for Medicare and Medicaid Services ............................................................ ¶1230 Coverage and Reimbursement ..............................¶1231 CMS and FDA Regulation of Devices....................¶1232 Clinical Laboratory Improvement Amendments of 1988 ......................................................¶1233 CLIA and FDA Regulation of Devices .................. ¶1234 Federal Trade Commission Act............................ ¶1240 Organization of FTC................................................¶1241 FTC and FDA Regulation of Devices .....................¶1242 Consumer Product Safety Act .............................. ¶1250

tab 1000: exports and Imports

Executive Summary ............................................. ¶1000 Exports ..................................................................¶1010 Export of Legal Devices.......................................... ¶1011 Export of Devices Not in Compliance With the Act.........................................................................¶1012 Export Certificates ..................................................¶1013 Export Under Radiation Control for Health and Safety Act of 1968 ........................................¶1014 Export of Condemned Articles ..............................¶1015 Import for Export.....................................................¶1016 Unfinished Devices ................................................ ¶1017 Devices for Exotic Diseases ...................................¶1018 Imports................................................................. ¶1020 Obligations of Foreign Manufacturers and Importers .............................................................¶1021 Import Procedures ..................................................¶1022 FDA Inspection and Sampling ..............................¶1023 Import Detention.....................................................¶1024 Reconditioning........................................................¶1025 Bond Actions .......................................................... ¶1026 Import Alerts and Automatic Detentions .............¶1027 Are FDA Automatic Detentions Actually Rulemakings? ............................................................ ¶1028

tab 1300: state Regulation and Preemption

Executive Summary ............................................. ¶1300 Preemption for Product Liability ..........................¶1301 Scope and Implementation of Preemption ..........¶1310 State or Local Regulations Not Subject to Preemption .......................................................... ¶1311 Exemption from Preemption ............................... ¶1320 Responsibility for Preemption Exemption...........¶1321 Procedures for Exemption -- Content and Form of Application ............................................¶1322 Application Process for Exemption ......................¶1323

tab 1100: enforcement

Executive Summary ..............................................¶1100 Administrative Actions .......................................... ¶1101 Judicial Actions ....................................................... ¶1102 The Presumption of Interstate Commerce ..........¶1103 Device Violations ..................................................¶1110 Adulteration ............................................................ ¶1111 Misbranding ............................................................ ¶1112 Specific Prohibitions .............................................. ¶1113 Administrative Recall and Notification ...............¶1120

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Tab 1300 (cont'd) Revocation of an Exemption ..................................¶1324 Advisory Opinions ..................................................¶1325 Personal Injury Claims ....................................... ¶1330 Strict Liability -- Failure to Warn ..........................¶1331 Strict Liability -- Design Defects ...........................¶1332 Negligence ...............................................................¶1333 Status of Personal Injury Claim -- Relationship to Preemption.............................. ¶1334

Volume two

(See Volume 2 Table of Contents for more information)

appendix II: federal Regulations appendix III: fDa Preamble, Guidance and other advisory Documents appendix IV: fDa forms appendix V: Proposed Regulations Glossary Index

appendix I: federal laws

Federal Food, Drug, and Cosmetic Act, as Amended (21 USC §321 et seq.) Selected Sections Chapter II -- Definitions Chapter III -- Prohibited Acts Chapter V -- Drugs and Devices Chapter VII -- General Authority Chapter VIII -- Imports and Exports Chapter IX -- Miscellaneous

Guide to Medical Device Regulation

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