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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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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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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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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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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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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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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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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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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
OCR for page 298
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
