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From page 287... ... 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) Read the entire page →
From page 288... ... 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. Read the entire page →
From page 289... ... 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. Read the entire page →
From page 290... ... 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) Read the entire page →
From page 291... ... 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) Read the entire page →
From page 292... ... , 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) Read the entire page →
From page 293... ... , 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 Read the entire page →
From page 294... ... 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 Read the entire page →
From page 295... ... , 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 Read the entire page →
From page 296... ... 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) Read the entire page →
From page 297... ... ) 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) Read the entire page →
From page 298... ... 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 Read the entire page →

From page 287...

... 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)

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From page 288...

... 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.

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From page 289...

... 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.

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From page 290...

... 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)

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From page 291...

... 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)

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From page 292...

... , 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)

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From page 293...

... , 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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From page 294...

... 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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From page 295...

... , 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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From page 296...

... 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)

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From page 297...

... ) 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)

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From page 298...

... 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

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Index Pages 287-298

Index
Pages 287-298