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Index [Page numbers followed by b, f, or t refer to American College of Cardiology, 139–140 boxed text, figures, or tables, respectively.] Appian program, 79 Australia, 173, 182 A B Abbreviated 510(k) submission, 101, 102–103 Banning of devices, 56–57 ACTION–Get With the Guidelines, 140 Biliary stents, 99b Administrative Procedure Act, 60, 226 Binding letter of determination, 109 Adverse event reporting Biologic medical products, 153–155 data sources, 129–130 definition of adverse event, 123 C devices with multiple predicates as source of, 92 Canada, 173, 182 frequency and distribution, 125t, 126 Cardiovascular Assessment, Reporting, and General Accounting Office review of, Tracking system, 138 265 CDRH. See Center for Devices and Health and Human Services inspector Radiological Health general review of, 274–275 CDRH Preliminary Internal Evaluations, real-time, 130 22–23 requirements for, 38, 46, 53, 125–127, Center for Biologics Evaluation and 272 Research, 74–75, 154 voluntary, 126 Center for Devices and Radiological Health See also Medical device report (CDRH) Advertising, regulation of, 48, 98 consideration of off-label use as intended Agency for Healthcare Research and use, 98–99 Quality, 18, 141 databases, 20, 90 American Academy of Orthopaedic enforcement authority, 55 Surgeons, 141 financial resources, 73–74 287

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288 INDEX goals for 510(k) program, 190 recommendations for new regulatory information management system, 78–79, framework, 8–9, 196–197 128, 201 recommendations for research on medical staff, 261 alternatives to 510(k) process, 11, policies and programs on device 201 innovation, 165, 167–168 review and clearance requirements, 1, postmarket monitoring capacity, 42, 62 3, 4, 32, 71, 86–87, 208, 218–219, purpose, 15 220, 221, 249–251, 266–267 quality assurance programs, 80–81, 82, special controls, 1–3, 2b, 50–52, 71, 201–202, 260–261 104, 250–251 recommendations for clearance process, third-party review program, 75–77 23–26, 24–25b, 210, 211 Class III medical devices requirements for 510(k) submission, 252 definition, 2b, 31, 50, 68, 219 resource and capability limitations, 42, devices excepted, 86–87, 222–223 73, 74, 80, 82, 224–225 device tracking regulations, 48–49, 271 review of premarket notification evolution of legislative regulation, clearance process, 22–23, 96, 190, 30–33, 34, 100, 255–256 195 number of 510(k) submissions and review times, 111–112 clearance rate, 274 staffing, 74–75, 224–225 pathways to market entry, 85–86, 116, See also Food and Drug Administration 228, 241 (FDA) postmarket surveillance requirements, Center for Drug Evaluation and Research, 49, 271 74–75, 154 premarket review and approval Centers for Medicare and Medicaid requirements, 1, 3, 32, 69–70, 208, Services, 139, 171 219, 221–223 China, 173 prevalence of new technology in, Class I medical devices 107–108, 191 clearance rate, 273–274 recommendations for review of definition, 2b, 31, 218 preamendment device types, 13, 204 evolution of legislative regulation, 30–33 status of FDA review of preamendment pathways to market entry, 85–86, 116 devices, 13, 100–101, 204 review and approval requirements, Classes of medical device types, 1, 2b, 1, 3, 32, 86–87, 218, 220, 221, 30–31, 68, 86–87 266–267 distribution, 3 third-party review program, 75–77 pathways to clearance or approval, Class II medical devices 85–86, 116, 208 clearance rate, 273–274 See also specific class definition, 2b, 31, 50, 218, 250 Clinical registries, 139–141 device tracking regulations, 48–49, 271 Clinical trials for devices, 73, 107–109 evolution of legislative regulation, Combination products, 153–156 30–33, 34, 71, 237–239, 249 Computed axial tomography, 155 General Accounting Office review of Conditional clearance, 11, 201 FDA oversight, 235–236 Conformity assessment, 177, 180, 181t pathways to market entry, 4, 5, 85–86, Congress, U.S. 116 appropriations for review and clearance performance standards, 4, 237–238, process, 3, 10, 38, 39, 40, 276 240–242, 245, 249–250, 270 FDA oversight and legislative control, postmarket surveillance requirements, 209–210 49, 271 House Subcommittee on Health and prevalence of new technology in, Environment, 228, 236–239, 107–108, 191 243–244, 247

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289 INDEX House Subcommittee on Oversight and Different technological characteristics Investigations, 239–240, 248 definition, 88 oversight of Medical Device frequency of, in 510(k) applications, 91 Amendments implementation, safety and effectiveness evaluations, 6, 233–235 191 recommendations for, 8, 9, 10, 11, 196, substantial equivalence review, 3b, 91 198, 200 Directorate General for Health and in regulation of medical practice, 97–98 Consumers, 174 reviews of Medical Device Amendments Drug review and approval process, 17–18, implementation, 236–249 94, 208, 212 See also Legislative requirements for medical device review and approval E process Containers for devices, 43 eConsults, 79 Contamination prohibitions, 43 Effectiveness of device Criminal prosecutions, 56, 133 definition, 18 Customs and Border Protection, 59 efficacy versus, 18 See also Safety and effectiveness of medical devices D Efficacy versus effectiveness, 18 Dalkon Shield, 213–214 Electromagnetic interference, 161–162 Data collection and management. See Electronic health records, 141 Information collection and Emergency Care Research Institute, 142 management European Committee for Electrotechnical Data Extraction and Longitudinal Trend Standardization, 178 Analysis system, 138 European Committee for Standardization, 178 Defective products European Medicines Agency, 174 removal or correction of, 45, 53, 57 European Union, 173, 174–180 repair or replacement of, 58 Evidentiary requirements in 510(k) review, Defibrillators, 161–162 3, 5, 36, 102, 104–109, 110–111, De novo process 268–269 approval rate, 117 Executive orders, 60–61 CDRH recommendations for, 24b External expertise in clearance process, 11, legislative authorization, 267 201 number of requests for, 117, 117f origins, 115–116 F recommendations for considering modification of, 11, 201 False claims of compliance, 43 requirements, 116–117, 169 FDA. See Food and Drug Administration review times, 117, 118f Federal Food, Drug, and Cosmetic Act special controls in, 104 (1938), 30, 45, 97, 225 success of, as alternative regulatory civil penalty provisions, 58, 258 pathway, 117 definition of medical device under, 16–17 Department of Health and Human enforcement provisions, 59 Services, 61, 73, 248–249, 260–261, origins, 211–212 274–275 postmarket surveillance provisions, 132 Department of Justice, 54–55 review and approval requirements for Department of Veterans Affairs, 138 new medical devices, 1, 208 Design and development controls, 103, Section 510(k), 1. See also Premarket 112–114, 259 notification (510(k)) clearance process Detention of suspect devices, 59

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290 INDEX recommendations for quality Federal Regulation of Medical Devices– Problems Still to Be Overcome, 235 improvement program, 11–12, Federal Trade Commission, 48 201–202 510(k) clearance process. See Premarket recommendations for research for notification (510(k)) clearance process development of new regulatory 515 Program Initiative, 100 framework for medical devices, 8–9, Food and Drug Administration (FDA) 196–198 administrative enforcement powers, recommendations for resource 56–60 utilization, 7–8, 198 authority to regulate advertising, 48, 98 recommendations for review of challenges in regulating medical devices, regulatory authorities, 10–11, 200 17–19 recommendations for software compliance and enforcement activities, evaluations and guidance, 13, 133–137, 212, 258 203–204 controls applicable to higher-risk regulation of imported medical devices devices, 46–48 by, 173–174 device tracking requirements, 48–49, in regulation of medical practice, 97–98 129 resource and capability limitations, 7, drug regulatory framework versus device 29, 33, 38, 75, 112, 194, 198–199, regulatory framework, 62–68 209–210, 224–225, 229, 276 exercise of authorities and powers over role in facilitating innovation, 7, 12, medical devices, 62, 82 165–166, 167–168, 195–196, 197, funding for review and approval 202 programs, 73–74, 209 special controls for Class II devices, general controls affecting marketed 50–52 devices, 42–46 staffing, 74–75, 224–225 guidance documents, 104–105, 107, 108 Summary Technical Document pilot information systems, 12, 77–79, 119, program, 183 128–129, 172, 198–199, 202, See also Center for Devices and 274–275 Radiological Health; Premarket judicial enforcement powers, 54–56 approval; Premarket notification legal constraints on authority of, 209, (510(k)) clearance process 225–227 Food and Drug Administration legislative requirements for medical Amendments Act (2007), 62–63, 65, device review and approval process, 67–68, 98, 130–131, 132, 273 1–4, 30–40 Food and Drug Administration management of emerging safety issues, Modernization Act (1997), 3, 37–38, 64, 66–67t 76, 116, 150, 169, 265–272 monitoring powers, 52–54 Future of Drug Safety, The, 62 opportunities for improved surveillance, 133 G organizational structure for medical device regulation, 15 General Accounting Office, 209, 235–236, political environment, 209, 261–262 242, 244–247, 265 postmarket surveillance requirements, General tools, clinical application of, 49 95–96, 118–119 procedural requirements for exercise of Global Harmonization Task Force, 174, regulatory authority, 60–62 182–183, 184 recommendations for modified de novo Good manufacturing practices, 259 process pilot program, 11, 201 Government Accountability Office, recommendations for postmarketing 273–274 surveillance, 10, 200

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291 INDEX Guidance documents, 101, 102, 104–105, shortcomings of current system, 12, 20, 107, 108 77–79, 81, 90–91, 99–100, 118, 119, 128, 142, 143, 144, 172, 184, 192, 198–199, 202 H software-associated recalls, 156–157 timely communication of risk-benefit Health Insurance Portability and information, 67–68 Accountability Act, 131 unique device identifiers, 132–133, 143 Hip replacement devices, 16 See also Adverse event reporting; Humanitarian-device exemption to Medical device report; Postmarket premarket approval, 4 surveillance; Research needs Innovation, 5 attributes of ideal regulatory system, 21 I complexity of devices submitted for 510(k) clearance, 151–152, 184 Importation of devices, 53, 59, 86, 173 in context of medical devices, 165, 167 India, 173 definition, 7, 19, 164–165, 166, 167, Indications for use, 92–96, 98–99, 268` 193 Industry. See Manufacturers of medical economics of, 170, 171 devices effects of premarket notification process, Information collection and management 6–7, 19, 35–36, 39, 167–169, 172, administrative databases, 139 184, 193–194 clinical registries, 139–141, 172 emergence of entirely new technologies, database of predicate devices, 89–91, 155 118 evolution of medical device regulation, design and development control 168–169 documents, 113–114 FDA role in fostering, 7, 12, 165–166, device master record, 114 167–168 device tracking requirements, 48–49, IDEAL model, 166 129 measures of, 12, 202 electronic health records, 141 perception of positivity in, 165, 167 FDA management information, 75 priority status of, in FDA review, 86, future of medical-device interaction, 168, 270–271 162, 162f process of, 166–167 inspections of manufacturing plants, recommendations for facilitating, 12, 133–134 202–203 Internet use, 67–68 review times for innovative devices, 112 online posting of 510(k) application, role of regulatory process in facilitating, 90–91 7, 195–196, 197 non-FDA sources of postmarket substantial equivalence requirements performance data, 137–142, 144, and, 168–169 199 Inspections of manufacturing plants, 48, on off-label use, 99–100 53–54, 74, 133–134 recall data, 135–137, 192 Instructions for use, 44–45 recommendations for research to design Insurance coverage, 170 new regulatory framework, 8–9, Intended use, 92–96, 98–99, 115 196–198 International comparison in reimbursement system, 171 globalization of medical device industry, request for additional information in 173–174, 184 510(k) review, 110–111 harmonization of regulatory approaches, 174, 182–183

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292 INDEX M postmarketing vigilance, 181 production and consumption of medical Magnetic resonance imaging, 155 devices, 173 Maintenance of Certification, 172 product recalls, 173 Malfunction report regulation of medical devices, 173–180, data sources, 125–127 184 definition, 123 of regulatory frameworks, Manufacturer and User Device Experience, recommendations for, 9, 197 128 of risk classification, 178–179, 179t Manufacturers of medical devices International Organization for design controls, 259 Standardization, 178 globalization of industry, 173–174, Intravascular filters, 136b 184 In vitro diagnostic devices, 108, 117 innovation among, 170 iReview, 79 market characteristics, 169–170, 173 perceptions of 510(k) process, 171, 172, 184, 210 J plant inspections, 48, 53–54, 74, Japan, 173, 182 133–134 quality improvement requirements for, 80–81, 112–114 K registration, 43–44, 53 required surveillance of postmarket Knee repair devices, 16 performance, 49, 53, 70 startup companies, 170 Master record, 114 L MD EpiNet program, 130, 139, 198 Medical Device Amendments (1976), 41, Labeling 209 for combination products, 154 classification of medical devices under, contents, 44 1, 30–32, 68, 86–87, 217–219 FDA authority to change, 65, 98, 115 congressional reviews of FDA FDA monitoring powers, 53 implementation, 228, 229–230, indications for use, 94–95, 98–99 233–249 instructions for use, 44–45 definitions of products in, 214–215 intended use, 98 effects of resource and process for prescription devices, 114 constraints, 227–231 recommendations for, 9, 197 general controls, 201, 215–217 regulatory controls, 43, 44 intent of Congress in, 15, 276 requirements for premarket approval, major provisions, 30, 97–98, 100, 168, 115 191–192, 219–221 requirements of 510(k) notification, origins, 213–214 114–115 promulgation of regulations under, 226 Legislative requirements for medical device resource demands for implementation review and approval process of, 224–225 constraints on FDA authorities, 209 restricted device provisions, 226–227 definition of medical device in, 16–17, Safe Medical Devices Act and, 249 212–213 scope of coverage, 214, 225–226 de novo process, 267 substantial equivalence provisions, historical development, 1–4, 29, 30–39, 32–33 47, 70–71, 209–210, 212–214 Medical Device Amendments (1992), See also specific legislation 259–260 Listings of products, 44

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293 INDEX O Medical device report data sources, 125–127 Office of Combination Products, 154, 155 electronic reporting, 128 Office of Device Evaluation, 90, 133, 261 investigative response, 126, 127–128 Office of In Vitro Diagnostics, 90, 133 recalled devices as subject of, 137 Office of Management and Budget, 61 shortcomings of current system, 127, Office of Technology Assessment, 229–230, 128 240–242 timeliness of review, 127 Off-label uses of devices, 37, 97–100, 115 types of, 123. See also specific type recall actions related to, 135 Medical device review process Orthopedic registries, 140–141 combination products, 153–156 medical devices defined, 16–17 pathways to, 4, 5, 32–33, 85–86, 116, P 208 See also De novo process; Premarket Pacemakers, 161–162 approval; Premarket notification Patent protection, 35 (510(k)) clearance process; online posting of application data and, Regulatory framework for medical 90–91 devices Performance standards Medical Devices: FDA’s 510(k) Operations for Class II devices, 4, 226, 237–238, Could Be Improved, 244–246 240–242, 245, 249–250, 270 Medical Devices Technical Corrections Act concerns about use of, 107 (2004), 273 conformity with, as evidence of Medical Device User Fee and Modernization substantial equivalence, 107 Act (2002), 154, 272–273 FDA authority to regulate devices Medical Device User Fee Stabilization Act through, 47, 51 (2005), 273 FDA review and recognition, 105 Medical Product Surveillance Network, potential scope of, 51, 105 129–130 promulgation of, 226 Medical-tubing connectors, 16 requirements for new medical devices, 1, Medicare Coverage with Evidence 2b Development, 171 resource demands for development of, MedSun program, 129–130, 143, 198 245–246 Medtronics Software Application Card, sources of, 105 158, 158b Piggybacking (chain of equivalent devices), Medtronic v. Lohr, 36–37, 262–265 33, 35, 81, 88, 118, 252–253 MedWatch program, 126 Postmarket surveillance Modification to cleared products, 89, 104, attributes of ideal regulatory system, 150 21–22 Multiple predicate devices, 92, 152–153 of combination products, 154 confidentiality issues in, 131 current inadequacies in, 6, 9–10, N 99–100, 119, 129, 143, 144, 172, 184, 192, 198–199 National Cardiovascular Data Registry, 140 data collection and management, 143 National Formulary, 16 data management, 127–129 National Hospital Discharge Survey, 139 data sources, 49, 52–54, 124–127, 143, Nationwide Inpatient Sample, 139 275–276 Notice-and-comment rule-making, 47, device tracking requirements, 48–49, 51, 60–61 129, 257, 271

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294 INDEX enhanced strategies, 129–133 number of submissions and clearance European system, 181 rate, 274 FDA data collection, 43–46, 49, 52–54, premarket notification clearance process 63–64, 64t, 124 versus process for, 72–73, 72t, 82, future prospects, 133, 143–144, 172 91, 192, 194, 263 legislative provisions for, 34, 38, priority review for innovative 256–257, 271 technologies, 86, 270–271 non-FDA data sources, 137–142, 144, recommendations for processing 199 preamendment device types, 13, 204 off-label use of devices, 99 required reporting of postmarketing rationale, 123, 171–172, 199, 207–208, performance, 70 210–211 requirements for preamendment devices, recommendations for, 10–11, 199–200 100 regulatory framework, 208–209 resource demands, 75, 229, 243–244, reliability of data, 275–276 274 requirements for manufacturers, 49, 53, restricted devices, 47 70, 132 review times, 75, 267 Section 522 requirements, 132 scope of review, 269–270 timely communication of risk-benefit status of FDA review of preamendment- information, 67–68 eligible Class III devices, 13, 100– See also Adverse event reporting; 101, 204 Medical device report suspension of, 60 Predicate devices user fee program, 3, 29, 38–39, 69, 70, applications citing new intended use or 74, 272–273 different indication for use from, 3b, utilization, 4, 85 96 Premarket notification (510(k)) clearance clearance in absence of, 6, 11, 115–117 process clinical data availability for, 108 abbreviated submission, 101, 102–103 complexity of 510(k) submissions, approach to evaluation of, 19–20, 152–153 189–190 definition, 15, 35, 88 CDRH review of, 22–26, 96, 190, 195 discontinued or unmarketed devices as, combination products, 153–156 89 complexity of devices submitted for, FDA databases, 89–91, 118 151–152 multiple, 92, 136–137, 152–153 complexity of submissions for, 152 safety and effectiveness review of, 5–6, concerns about, 4, 15–16, 275–276 89, 191 consistency and predictability of, 109, shortcomings of current review and 171, 172, 184, 195, 210 approval system, 6, 12, 24b, 91 cost of, 274 split, 92, 153 data sources, 12, 20 See also Substantial equivalence decisions of, as legally binding Premarket approval precedents, 12, 34–35, 39, 202 application process, 69–70 design control information in, 114 conditional, 70 devices required to undergo, 86 cost of, 274 discontinued or unmarketed devices denial, 69–70 cleared by, 89 excepted devices, 86–87, 100 distribution of submission types, 101 “indications for use” provisions, 94 effects on innovation, 6–7, 12, 19, labeling requirements, 115 35–36, 39, 167–169, 172, 184, legislative provisions, 32–33, 34, 38, 193–194, 202 100, 219–220, 269–270 establishment of, 15, 33

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295 INDEX evolution of legislative requirements, 30, third-party review program, 75–77, 77f, 32–33, 34–40 78t, 267 FDA use of outside expertise for, 110, traditional submission, 101–102 150 transition to implementation, 221–223 industry evaluations of, 171, 172, 184 types of medical devices submitted for, international comparison, 173 151, 151f labeling data required by, 114–115 types of submissions for, 101 within larger medical-device regulatory use of clinical data in, 107–109, 119, 195 framework, 4–5, 9, 19, 41, 198 user fee program, 38–39, 40, 74, 272 online posting of application data, utilization, 3, 4, 85, 170–171, 228 90–91 See also Substantial equivalence number of submissions, 149–150, 150f, Prescription devices, 47, 48 273–274 Product Code (Procode) Classification page count of submissions for, 152f Database, 89–90, 151, 151f premarket approval versus, 72–73, 72t, Pure Food and Drug Act (1906), 30, 211 82, 91, 192, 194, 263 quality assurance system, 80–81 Q quality of clinical data in, 261 rate of clearance, 81, 86, 191–192, Quality improvement program 230–231, 231t, 232t, 273–274 attributes of ideal regulatory system, 21 recommendations for, 7–8, 198 CDRH recommendations for, 24b recommendations for preamendment- goals, 11–12 eligible Class III device types, 13, 204 recommendations for, 11–12, 201–202 request for additional information in, requirements for manufacturers, 80–81, 110–111 112–114 requirements for classes of medical shortcomings of regulatory system, 80, device types, 1, 3 81, 82, 260–261 requirements for modification to cleared devices, 89, 104, 150 resource demands, 75, 229, 243–244, R 274 review cycles, 112, 112f Reasonable assurance of safety, 18, 189, review times, 75, 106t, 107, 109–112, 190, 193, 196, 202 111f, 153, 171, 224, 255, 265–266, Recalled products. See Removal or 271 correction of products safety and effectiveness evaluations in, Recast of the Medical Devices Directive, 5–6, 15–16, 33, 39, 193, 210 175–176 source of growth in utilization of, Recommendations 228–231 from CDRH, 23–26, 24–25b, 210, 211 special controls and, 51–52 for development of new regulatory special submission, 101, 103–104 framework, 8–9, 196–197 statement, 90 for device labeling, 9, 197 submission guidelines, 101, 102, for facilitating innovation in medical- 104–105 device industry, 12, 202–203 substantial equivalence requirements for postmarket surveillance, 9–11, and, 5, 86, 190–191, 268–269 198–200 summary, 90 for premarket notification clearance Summary Technical Document pilot process, generally, 7–8, 198 program and, 183 for quality improvement program, Supreme Court review of, 36–37, 11–12, 201–202 262–265 for review of de novo process, 11, 201

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296 INDEX for review of preamendment Class III Removal or correction of products devices, 13, 204 causes of, 112, 113, 246 for software evaluations, 13, 203–204 characteristics of recalled devices, Registration of manufacturers, 43–44, 53 136–137, 246–247 Regulatory framework for medical devices, FDA authority, 57 4 frequency of FDA actions, 136 authority for monitoring and as indicator of product safety, 135–137, surveillance, 52–54 192 challenges in, 17–19 international comparison, 173 clinical trials requirements in, 108 limitations of recall data, 135–137, 192 consideration of emerging technologies, manufacturers’ reporting responsibilities, 8 53 controls applicable to higher-risk orthopedic registries for, 140–141 devices, 46–48 public awareness, 142–143 versus drug regulatory framework, repair or replacement of defective 62–68 devices, 58 enforcement and remedies, 54–60, Safe Medical Devices Act provisions for, 133–137 257–258 environment affecting FDA device software problems as cause of, 156–159, regulation, 261–262 164, 184 external developments affecting, 149 types of regulatory actions, 134–135 facilitating innovation in, 7 Repackagers, 86 forces affecting, 209–211 Research needs funding, 73–74 for alternatives to 510(k) process, 11, general controls, 41–46, 215–217 201 historical evolution, 29 for development of regulatory ideal attributes, 9, 21–22, 21b, 197 framework, 8–9, 196–197 impact analysis requirements, 225 on effects of 510(k) process on international comparison, 9, 173–180, innovation, 12, 195, 202–203 184, 197 postmarketing surveillance, 9–10, international harmonization, 174, 199–200 182–183 recommendations for analysis of medical life cycle model, 41 device software, 13, 203 participants in design of, 9, 198 Restricted devices, 46–48, 226–227 postmarket, 208–209 Restrictions on sale or use of device, 65–66 premarket notification clearance process Risk assessment in context of, 4–5, 9, 19, 41, 198 attributes of ideal regulatory system, 22 procedural requirements, 60–62 in classes of recall actions, 135 recommendations for research to in classification of medical device types, replace, 8–9, 196–198 1, 2b, 31–32, 68, 191 recommendations for review of FDA in de novo application process, 116 postmarket authorities, 10–11, device tracking requirements based on, 198–200 48–49 regulatory framework for drugs versus, drug regulatory framework, 63 17–18 FDA administrative enforcement See also Food and Drug Administration powers, 56–60 (FDA); Premarket approval; international comparison of device Premarket notification (501(k)) regulation, 178–179, 179t clearance process plant inspections, 133–134 Relabelers, 86 Risk Evaluation and Mitigation Strategy, Remedies and sanctions, 54–60, 133–137, 63, 65, 98 212, 258 Sentinel Inititative, 63, 130–132

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297 INDEX timely communication of findings, 67–68 shortcomings of current data sources for, See also Postmarket surveillance 6, 12, 143, 192, 193 Risk notification requirements, 57–58 software evaluations, 13, 162–164, 203–204 substantial equivalence as standard for S clearance and, 5–6, 34–35, 36–37, 39–40, 88–89, 91, 190–191, 193, Safe Medical Devices Act (SMDA) (1990) 210, 241, 243, 253–255, 262–265 changes in premarket review process in, use of de novo process for, 11, 201 35, 249–251 See also Postmarket surveillance design validation requirements, 103, 259 Section 510(k). See Premarket notification essential provisions, 2–3, 34–37 (510(k)) clearance process implications for innovation, 35–36 Section 522 surveillance, 132, 143 on postmarket surveillance, 125–126, Seizure of violative products, 55 256–257 Sentinel Initiative, 63, 130–132, 198 on preamendment Class III devices, Software 255–256 as basis for product recalls, 156–159, purpose, 34, 249 164, 184 on removal and correction of devices, in combination products, 155 257–258 FDA guidance, 158 review time requirements, 255 in networked information systems, on substantial equivalence, 35, 36–37, 160 168–169, 191, 251–255 off-the-shelf, 156, 158 Safety and effectiveness of medical devices patches, 159 classification of medical device types, 2b, product lines, 156 31–32, 217–219 recommendations for FDA regulation concerns about premarket notification and guidance, 13, 203–204 process, 15–16 research needs, 13, 203 current state of, 6, 16, 32, 39, 192, 193 significance of, in medical devices, 156 definitions and measurement of, 18 sources of risk in, 159–160 design controls, 259 testing procedures, 159 design of premarket notification trends in medical device technology, 164, clearance process and, 33, 39 184 FDA authority to manage emerging validation, 160–164 safety issues, 64, 66–67t Special controls FDA authority to restrict use of application, 51, 104 approved devices, 65–66 in context of 510(k) clearance process, General Accounting Office review of 51–52 FDA oversight, 235–236 legislative authority, 2–3, 2b, 4, 34, 50, goals of medical-device regulation, 21 250–251 historical evolution of legislative limitations, 51–52, 210 requirements, 212, 220–221 recommendations for modified de novo international comparison of regulatory process pilot program, 11, 201 systems, 176, 177 Split predicate devices, 92, 152–153 preamendment devices, 6, 31, 32 Standards in 510(k) review. See Performance rationale for postmarket surveillance, standards 123 Stents, 99b reasonable assurance of, 18 Substantial equivalence recall data as indicator of, 135–137, 192 chain of devices, 33, 35, 81, 88, 91, 118, recommendations to improve, 8, 13, 252–253 196–197, 203–204

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298 INDEX clinical application of general tool, utilization of, for approval of Class II 95–96, 118–119 devices, 4 clinical data in support of claim of, See also Predicate devices 107–109 Summary Technical Document program, conformity with standards as evidence 182–183 of, 107 Supreme Court review of 510(k) process, consistency and predictability of review 36–37, 262–265 process, 91, 96, 107, 109–112 Surgical mesh, 16 decision tree, 93f definition, 3b, 33, 34, 36, 87, 88, 223, T 245, 251–252, 253–254 evidentiary requirements, 3, 36, 102, Third-party review, 75–77, 77f, 78t, 267 104–109, 110–111, 268–269 Traction, 79 FDA guidance documents on, 104–105, Training of device operators, 46–47 252–253 Transparency findings of Center for Devices and industry perceptions of 510(k) process, Radiological Health, 24b 110, 171 General Accounting Office review of innovation and, 7, 194 FDA oversight, 235–236 public awareness of recalls and public innovation and, 168–169 health notices, 142–143 “intended use” and “indications for strategies to improve, 23, 77–78, 92 use” in determination of, 92–96 Transparency Initiative, 142–143 legislative provisions, 2, 32–33, 34–35, 86–87, 223–224, 251–255 in premarket notification clearance U process, 5, 86 rate of premarket clearance based on, Unique device identifiers, 132–133, 141, 33, 36, 191–192, 230–231, 231t, 143, 172 232t User fees, 3, 29, 38–39, 40, 69, 70, 74, 199, recommendations for new regulatory 272–273 framework to replace, 8, 196–197 safety and effectiveness of devices W approved on basis of, 5–6, 36–37, 39–40, 88–89, 91, 190–191, 210, Warning letters, 134 241, 243, 253–255, 262–265 @work toolset, 79 standard of noninferiority, 34–35, 88–89