[Page numbers followed by b, f, or t refer to boxed text, figures, or tables, respectively.]
A
Abbreviated 510(k) submission, 101, 102–103
ACTION–Get With the Guidelines, 140
Administrative Procedure Act, 60, 226
Adverse event reporting
data sources, 129–130
definition of adverse event, 123
devices with multiple predicates as source of, 92
frequency and distribution, 125t, 126
General Accounting Office review of, 265
Health and Human Services inspector general review of, 274–275
real-time, 130
requirements for, 38, 46, 53, 125–127, 272
voluntary, 126
See also Medical device report
Advertising, regulation of, 48, 98
Agency for Healthcare Research and Quality, 18, 141
American Academy of Orthopaedic Surgeons, 141
American College of Cardiology, 139–140
Appian program, 79
Australia, 173, 182
B
Banning of devices, 56–57
Biliary stents, 99b
Binding letter of determination, 109
Biologic medical products, 153–155
C
Canada, 173, 182
Cardiovascular Assessment, Reporting, and Tracking system, 138
CDRH. See Center for Devices and Radiological Health
CDRH Preliminary Internal Evaluations, 22–23
Center for Biologics Evaluation and Research, 74–75, 154
Center for Devices and Radiological Health (CDRH)
consideration of off-label use as intended use, 98–99
databases, 20, 90
enforcement authority, 55
financial resources, 73–74
goals for 510(k) program, 190
information management system, 78–79, 128, 201
medical staff, 261
policies and programs on device innovation, 165, 167–168
postmarket monitoring capacity, 42, 62
purpose, 15
quality assurance programs, 80–81, 82, 201–202, 260–261
recommendations for clearance process, 23–26, 24–25b, 210, 211
requirements for 510(k) submission, 252
resource and capability limitations, 42, 73, 74, 80, 82, 224–225
review of premarket notification clearance process, 22–23, 96, 190, 195
review times, 111–112
staffing, 74–75, 224–225
See also Food and Drug Administration (FDA)
Center for Drug Evaluation and Research, 74–75, 154
Centers for Medicare and Medicaid Services, 139, 171
China, 173
Class I medical devices
clearance rate, 273–274
definition, 2b, 31, 218
evolution of legislative regulation, 30–33
pathways to market entry, 85–86, 116
review and approval requirements, 1, 3, 32, 86–87, 218, 220, 221, 266–267
third-party review program, 75–77
Class II medical devices
clearance rate, 273–274
definition, 2b, 31, 50, 218, 250
device tracking regulations, 48–49, 271
evolution of legislative regulation, 30–33, 34, 71, 237–239, 249
General Accounting Office review of FDA oversight, 235–236
pathways to market entry, 4, 5, 85–86, 116
performance standards, 4, 237–238, 240–242, 245, 249–250, 270
postmarket surveillance requirements, 49, 271
prevalence of new technology in, 107–108, 191
recommendations for new regulatory framework, 8–9, 196–197
recommendations for research on alternatives to 510(k) process, 11, 201
review and clearance requirements, 1, 3, 4, 32, 71, 86–87, 208, 218–219, 220, 221, 249–251, 266–267
special controls, 1–3, 2b, 50–52, 71, 104, 250–251
third-party review program, 75–77
Class III medical devices
definition, 2b, 31, 50, 68, 219
devices excepted, 86–87, 222–223
device tracking regulations, 48–49, 271
evolution of legislative regulation, 30–33, 34, 100, 255–256
number of 510(k) submissions and clearance rate, 274
pathways to market entry, 85–86, 116, 228, 241
postmarket surveillance requirements, 49, 271
premarket review and approval requirements, 1, 3, 32, 69–70, 208, 219, 221–223
prevalence of new technology in, 107–108, 191
recommendations for review of preamendment device types, 13, 204
status of FDA review of preamendment devices, 13, 100–101, 204
Classes of medical device types, 1, 2b, 30–31, 68, 86–87
distribution, 3
pathways to clearance or approval, 85–86, 116, 208
See also specific class
Clinical registries, 139–141
Clinical trials for devices, 73, 107–109
Combination products, 153–156
Computed axial tomography, 155
Conditional clearance, 11, 201
Conformity assessment, 177, 180, 181t
Congress, U.S.
appropriations for review and clearance process, 3, 10, 38, 39, 40, 276
FDA oversight and legislative control, 209–210
House Subcommittee on Health and Environment, 228, 236–239, 243–244, 247
House Subcommittee on Oversight and Investigations, 239–240, 248
oversight of Medical Device Amendments implementation, 233–235
recommendations for, 8, 9, 10, 11, 196, 198, 200
in regulation of medical practice, 97–98
reviews of Medical Device Amendments implementation, 236–249
See also Legislative requirements for medical device review and approval process
Containers for devices, 43
Contamination prohibitions, 43
Criminal prosecutions, 56, 133
Customs and Border Protection, 59
D
Dalkon Shield, 213–214
Data collection and management. See Information collection and management
Data Extraction and Longitudinal Trend Analysis system, 138
Defective products
removal or correction of, 45, 53, 57
repair or replacement of, 58
Defibrillators, 161–162
De novo process
approval rate, 117
CDRH recommendations for, 24b
legislative authorization, 267
number of requests for, 117, 117f
origins, 115–116
recommendations for considering modification of, 11, 201
requirements, 116–117, 169
review times, 117, 118f
special controls in, 104
success of, as alternative regulatory pathway, 117
Department of Health and Human
Services, 61, 73, 248–249, 260–261, 274–275
Department of Justice, 54–55
Department of Veterans Affairs, 138
Design and development controls, 103, 112–114, 259
Detention of suspect devices, 59
Different technological characteristics definition, 88
frequency of, in 510(k) applications, 91
safety and effectiveness evaluations, 6, 191
substantial equivalence review, 3b, 91
Directorate General for Health and Consumers, 174
Drug review and approval process, 17–18, 94, 208, 212
E
eConsults, 79
Effectiveness of device
definition, 18
efficacy versus, 18
See also Safety and effectiveness of medical devices
Efficacy versus effectiveness, 18
Electromagnetic interference, 161–162
Electronic health records, 141
Emergency Care Research Institute, 142
European Committee for Electrotechnical Standardization, 178
European Committee for Standardization, 178
European Medicines Agency, 174
European Union, 173, 174–180
Evidentiary requirements in 510(k) review, 3, 5, 36, 102, 104–109, 110–111, 268–269
Executive orders, 60–61
External expertise in clearance process, 11, 201
F
False claims of compliance, 43
FDA. See Food and Drug Administration
Federal Food, Drug, and Cosmetic Act (1938), 30, 45, 97, 225
civil penalty provisions, 58, 258
definition of medical device under, 16–17
enforcement provisions, 59
origins, 211–212
postmarket surveillance provisions, 132
review and approval requirements for new medical devices, 1, 208
Section 510(k), 1. See also Premarket notification (510(k)) clearance process
Federal Regulation of Medical Devices–Problems Still to Be Overcome, 235
Federal Trade Commission, 48
510(k) clearance process. See Premarket notification (510(k)) clearance process
515 Program Initiative, 100
Food and Drug Administration (FDA)
administrative enforcement powers, 56–60
authority to regulate advertising, 48, 98
challenges in regulating medical devices, 17–19
compliance and enforcement activities, 133–137, 212, 258
controls applicable to higher-risk devices, 46–48
device tracking requirements, 48–49, 129
drug regulatory framework versus device regulatory framework, 62–68
exercise of authorities and powers over medical devices, 62, 82
funding for review and approval programs, 73–74, 209
general controls affecting marketed devices, 42–46
guidance documents, 104–105, 107, 108
information systems, 12, 77–79, 119, 128–129, 172, 198–199, 202, 274–275
judicial enforcement powers, 54–56
legal constraints on authority of, 209, 225–227
legislative requirements for medical device review and approval process, 1–4, 30–40
management of emerging safety issues, 64, 66–67t
monitoring powers, 52–54
opportunities for improved surveillance, 133
organizational structure for medical device regulation, 15
political environment, 209, 261–262
postmarket surveillance requirements, 49
procedural requirements for exercise of regulatory authority, 60–62
recommendations for modified de novo process pilot program, 11, 201
recommendations for postmarketing surveillance, 10, 200
recommendations for quality improvement program, 11–12, 201–202
recommendations for research for development of new regulatory framework for medical devices, 8–9, 196–198
recommendations for resource utilization, 7–8, 198
recommendations for review of regulatory authorities, 10–11, 200
recommendations for software evaluations and guidance, 13, 203–204
regulation of imported medical devices by, 173–174
in regulation of medical practice, 97–98
resource and capability limitations, 7, 29, 33, 38, 75, 112, 194, 198–199, 209–210, 224–225, 229, 276
role in facilitating innovation, 7, 12, 165–166, 167–168, 195–196, 197, 202
special controls for Class II devices, 50–52
staffing, 74–75, 224–225
Summary Technical Document pilot program, 183
See also Center for Devices and Radiological Health; Premarket approval; Premarket notification (510(k)) clearance process
Food and Drug Administration
Amendments Act (2007), 62–63, 65, 67–68, 98, 130–131, 132, 273
Food and Drug Administration
Modernization Act (1997), 3, 37–38, 76, 116, 150, 169, 265–272
Future of Drug Safety, The, 62
G
General Accounting Office, 209, 235–236, 242, 244–247, 265
General tools, clinical application of, 95–96, 118–119
Global Harmonization Task Force, 174, 182–183, 184
Good manufacturing practices, 259
Government Accountability Office, 273–274
Guidance documents, 101, 102, 104–105, 107, 108
H
Health Insurance Portability and Accountability Act, 131
Hip replacement devices, 16
Humanitarian-device exemption to premarket approval, 4
I
Importation of devices, 53, 59, 86, 173
India, 173
Indications for use, 92–96, 98–99, 268`
Industry. See Manufacturers of medical devices
Information collection and management
administrative databases, 139
clinical registries, 139–141, 172
database of predicate devices, 89–91, 118
design and development control documents, 113–114
device master record, 114
device tracking requirements, 48–49, 129
electronic health records, 141
FDA management information, 75
future of medical-device interaction, 162, 162f
inspections of manufacturing plants, 133–134
Internet use, 67–68
online posting of 510(k) application, 90–91
non-FDA sources of postmarket performance data, 137–142, 144, 199
on off-label use, 99–100
recall data, 135–137, 192
recommendations for research to design new regulatory framework, 8–9, 196–198
in reimbursement system, 171
request for additional information in 510(k) review, 110–111
shortcomings of current system, 12, 20, 77–79, 81, 90–91, 99–100, 118, 119, 128, 142, 143, 144, 172, 184, 192, 198–199, 202
software-associated recalls, 156–157 timely communication of risk-benefit information, 67–68
unique device identifiers, 132–133, 143
See also Adverse event reporting; Medical device report; Postmarket surveillance; Research needs
Innovation, 5
attributes of ideal regulatory system, 21
complexity of devices submitted for 510(k) clearance, 151–152, 184
in context of medical devices, 165, 167
definition, 7, 19, 164–165, 166, 167, 193
economics of, 170, 171
effects of premarket notification process, 6–7, 19, 35–36, 39, 167–169, 172, 184, 193–194
emergence of entirely new technologies, 155
evolution of medical device regulation, 168–169
FDA role in fostering, 7, 12, 165–166, 167–168
IDEAL model, 166
measures of, 12, 202
perception of positivity in, 165, 167
priority status of, in FDA review, 86, 168, 270–271
process of, 166–167
recommendations for facilitating, 12, 202–203
review times for innovative devices, 112
role of regulatory process in facilitating, 7, 195–196, 197
substantial equivalence requirements and, 168–169
Inspections of manufacturing plants, 48, 53–54, 74, 133–134
Instructions for use, 44–45
Insurance coverage, 170
Intended use, 92–96, 98–99, 115
International comparison
globalization of medical device industry, 173–174, 184
harmonization of regulatory approaches, 174, 182–183
postmarketing vigilance, 181
production and consumption of medical devices, 173
product recalls, 173
regulation of medical devices, 173–180, 184
of regulatory frameworks, recommendations for, 9, 197
of risk classification, 178–179, 179t
International Organization for Standardization, 178
Intravascular filters, 136b
In vitro diagnostic devices, 108, 117
iReview, 79
J
Japan, 173, 182
K
Knee repair devices, 16
L
Labeling
for combination products, 154
contents, 44
FDA authority to change, 65, 98, 115
FDA monitoring powers, 53
indications for use, 94–95, 98–99
instructions for use, 44–45
intended use, 98
for prescription devices, 114
recommendations for, 9, 197
regulatory controls, 43, 44
requirements for premarket approval, 115
requirements of 510(k) notification, 114–115
Legislative requirements for medical device review and approval process
constraints on FDA authorities, 209
definition of medical device in, 16–17, 212–213
de novo process, 267
historical development, 1–4, 29, 30–39, 47, 70–71, 209–210, 212–214
See also specific legislation
Listings of products, 44
M
Magnetic resonance imaging, 155
Maintenance of Certification, 172
Malfunction report
data sources, 125–127
definition, 123
Manufacturer and User Device Experience, 128
Manufacturers of medical devices
design controls, 259
globalization of industry, 173–174, 184
innovation among, 170
market characteristics, 169–170, 173
perceptions of 510(k) process, 171, 172, 184, 210
plant inspections, 48, 53–54, 74, 133–134
quality improvement requirements for, 80–81, 112–114
registration, 43–44, 53
required surveillance of postmarket performance, 49, 53, 70
startup companies, 170
Master record, 114
MD EpiNet program, 130, 139, 198
Medical Device Amendments (1976), 41, 209
classification of medical devices under, 1, 30–32, 68, 86–87, 217–219
congressional reviews of FDA implementation, 228, 229–230, 233–249
definitions of products in, 214–215
effects of resource and process constraints, 227–231
general controls, 201, 215–217
intent of Congress in, 15, 276
major provisions, 30, 97–98, 100, 168, 191–192, 219–221
origins, 213–214
promulgation of regulations under, 226
resource demands for implementation of, 224–225
restricted device provisions, 226–227
Safe Medical Devices Act and, 249
scope of coverage, 214, 225–226
substantial equivalence provisions, 32–33
Medical Device Amendments (1992), 259–260
Medical device report
data sources, 125–127
electronic reporting, 128
investigative response, 126, 127–128
recalled devices as subject of, 137
shortcomings of current system, 127, 128
timeliness of review, 127
types of, 123. See also specific type
Medical device review process
combination products, 153–156
medical devices defined, 16–17
pathways to, 4, 5, 32–33, 85–86, 116, 208
See also De novo process; Premarket approval; Premarket notification (510(k)) clearance process; Regulatory framework for medical devices
Medical Devices: FDA’s 510(k) Operations Could Be Improved, 244–246
Medical Devices Technical Corrections Act (2004), 273
Medical Device User Fee and Modernization Act (2002), 154, 272–273
Medical Device User Fee Stabilization Act (2005), 273
Medical Product Surveillance Network, 129–130
Medical-tubing connectors, 16
Medicare Coverage with Evidence Development, 171
MedSun program, 129–130, 143, 198
Medtronics Software Application Card, 158, 158b
Medtronic v. Lohr, 36–37, 262–265
MedWatch program, 126
Modification to cleared products, 89, 104, 150
Multiple predicate devices, 92, 152–153
N
National Cardiovascular Data Registry, 140
National Formulary, 16
National Hospital Discharge Survey, 139
Nationwide Inpatient Sample, 139
Notice-and-comment rule-making, 47, 60–61
O
Office of Combination Products, 154, 155
Office of Device Evaluation, 90, 133, 261
Office of In Vitro Diagnostics, 90, 133
Office of Management and Budget, 61
Office of Technology Assessment, 229–230, 240–242
Off-label uses of devices, 37, 97–100, 115 recall actions related to, 135
Orthopedic registries, 140–141
P
Pacemakers, 161–162
Patent protection, 35
online posting of application data and, 90–91
Performance standards
for Class II devices, 4, 226, 237–238, 240–242, 245, 249–250, 270
concerns about use of, 107
conformity with, as evidence of substantial equivalence, 107
FDA authority to regulate devices through, 47, 51
FDA review and recognition, 105
potential scope of, 51, 105
promulgation of, 226
requirements for new medical devices, 1, 2b
resource demands for development of, 245–246
sources of, 105
Piggybacking (chain of equivalent devices), 33, 35, 81, 88, 118, 252–253
Postmarket surveillance
attributes of ideal regulatory system, 21–22
of combination products, 154
confidentiality issues in, 131
current inadequacies in, 6, 9–10, 99–100, 119, 129, 143, 144, 172, 184, 192, 198–199
data collection and management, 143
data management, 127–129
data sources, 49, 52–54, 124–127, 143, 275–276
device tracking requirements, 48–49, 51, 129, 257, 271
enhanced strategies, 129–133
European system, 181
FDA data collection, 43–46, 49, 52–54, 63–64, 64t, 124
future prospects, 133, 143–144, 172
legislative provisions for, 34, 38, 256–257, 271
non-FDA data sources, 137–142, 144, 199
off-label use of devices, 99
rationale, 123, 171–172, 199, 207–208, 210–211
recommendations for, 10–11, 199–200
regulatory framework, 208–209
reliability of data, 275–276
requirements for manufacturers, 49, 53, 70, 132
Section 522 requirements, 132
timely communication of risk-benefit information, 67–68
See also Adverse event reporting; Medical device report
Predicate devices
applications citing new intended use or different indication for use from, 3b, 96
clearance in absence of, 6, 11, 115–117
clinical data availability for, 108
complexity of 510(k) submissions, 152–153
definition, 15, 35, 88
discontinued or unmarketed devices as, 89
FDA databases, 89–91, 118
multiple, 92, 136–137, 152–153
safety and effectiveness review of, 5–6, 89, 191
shortcomings of current review and approval system, 6, 12, 24b, 91
split, 92, 153
See also Substantial equivalence
Premarket approval
application process, 69–70
conditional, 70
cost of, 274
denial, 69–70
excepted devices, 86–87, 100
“indications for use” provisions, 94
labeling requirements, 115
legislative provisions, 32–33, 34, 38, 100, 219–220, 269–270
number of submissions and clearance rate, 274
premarket notification clearance process versus process for, 72–73, 72t, 82, 91, 192, 194, 263
priority review for innovative technologies, 86, 270–271
recommendations for processing preamendment device types, 13, 204
required reporting of postmarketing performance, 70
requirements for preamendment devices, 100
resource demands, 75, 229, 243–244, 274
restricted devices, 47
review times, 75, 267
scope of review, 269–270
status of FDA review of preamendment-eligible Class III devices, 13, 100–101, 204
suspension of, 60
user fee program, 3, 29, 38–39, 69, 70, 74, 272–273
utilization, 4, 85
Premarket notification (510(k)) clearance process
abbreviated submission, 101, 102–103
approach to evaluation of, 19–20, 189–190
CDRH review of, 22–26, 96, 190, 195
combination products, 153–156
complexity of devices submitted for, 151–152
complexity of submissions for, 152
concerns about, 4, 15–16, 275–276
consistency and predictability of, 109, 171, 172, 184, 195, 210
cost of, 274
data sources, 12, 20
decisions of, as legally binding precedents, 12, 34–35, 39, 202
design control information in, 114
devices required to undergo, 86
discontinued or unmarketed devices cleared by, 89
distribution of submission types, 101
effects on innovation, 6–7, 12, 19, 35–36, 39, 167–169, 172, 184, 193–194, 202
establishment of, 15, 33
evolution of legislative requirements, 30, 32–33, 34–40
FDA use of outside expertise for, 110, 150
industry evaluations of, 171, 172, 184
international comparison, 173
labeling data required by, 114–115
within larger medical-device regulatory framework, 4–5, 9, 19, 41, 198
online posting of application data, 90–91
number of submissions, 149–150, 150f, 273–274
page count of submissions for, 152f
premarket approval versus, 72–73, 72t, 82, 91, 192, 194, 263
quality assurance system, 80–81
quality of clinical data in, 261
rate of clearance, 81, 86, 191–192, 230–231, 231t, 232t, 273–274
recommendations for, 7–8, 198
recommendations for preamendment-eligible Class III device types, 13, 204
request for additional information in, 110–111
requirements for classes of medical device types, 1, 3
requirements for modification to cleared devices, 89, 104, 150
resource demands, 75, 229, 243–244, 274
review cycles, 112, 112f
review times, 75, 106t, 107, 109–112, 111f, 153, 171, 224, 255, 265–266, 271
safety and effectiveness evaluations in, 5–6, 15–16, 33, 39, 193, 210
source of growth in utilization of, 228–231
special controls and, 51–52
special submission, 101, 103–104
statement, 90
submission guidelines, 101, 102, 104–105
substantial equivalence requirements and, 5, 86, 190–191, 268–269
summary, 90
Summary Technical Document pilot program and, 183
Supreme Court review of, 36–37, 262–265
third-party review program, 75–77, 77f, 78t, 267
traditional submission, 101–102
transition to implementation, 221–223
types of medical devices submitted for, 151, 151f
types of submissions for, 101
use of clinical data in, 107–109, 119, 195
user fee program, 38–39, 40, 74, 272
utilization, 3, 4, 85, 170–171, 228
See also Substantial equivalence
Prescription devices, 47, 48
Product Code (Procode) Classification Database, 89–90, 151, 151f
Pure Food and Drug Act (1906), 30, 211
Q
Quality improvement program
attributes of ideal regulatory system, 21
CDRH recommendations for, 24b
goals, 11–12
recommendations for, 11–12, 201–202
requirements for manufacturers, 80–81, 112–114
shortcomings of regulatory system, 80, 81, 82, 260–261
R
Reasonable assurance of safety, 18, 189, 190, 193, 196, 202
Recalled products. See Removal or correction of products
Recast of the Medical Devices Directive, 175–176
Recommendations
from CDRH, 23–26, 24–25b, 210, 211
for development of new regulatory framework, 8–9, 196–197
for device labeling, 9, 197
for facilitating innovation in medical-device industry, 12, 202–203
for postmarket surveillance, 9–11, 198–200
for premarket notification clearance process, generally, 7–8, 198
for quality improvement program, 11–12, 201–202
for review of de novo process, 11, 201
for review of preamendment Class III devices, 13, 204
for software evaluations, 13, 203–204
Registration of manufacturers, 43–44, 53
Regulatory framework for medical devices, 4
authority for monitoring and surveillance, 52–54
challenges in, 17–19
clinical trials requirements in, 108
consideration of emerging technologies, 8
controls applicable to higher-risk devices, 46–48
versus drug regulatory framework, 62–68
enforcement and remedies, 54–60, 133–137
environment affecting FDA device regulation, 261–262
external developments affecting, 149
facilitating innovation in, 7
forces affecting, 209–211
funding, 73–74
general controls, 41–46, 215–217
historical evolution, 29
ideal attributes, 9, 21–22, 21b, 197
impact analysis requirements, 225
international comparison, 9, 173–180, 184, 197
international harmonization, 174, 182–183
life cycle model, 41
participants in design of, 9, 198
postmarket, 208–209
premarket notification clearance process in context of, 4–5, 9, 19, 41, 198
procedural requirements, 60–62
recommendations for research to replace, 8–9, 196–198
recommendations for review of FDA postmarket authorities, 10–11, 198–200
regulatory framework for drugs versus, 17–18
See also Food and Drug Administration (FDA); Premarket approval; Premarket notification (501(k)) clearance process
Relabelers, 86
Remedies and sanctions, 54–60, 133–137, 212, 258
Removal or correction of products
causes of, 112, 113, 246
characteristics of recalled devices, 136–137, 246–247
FDA authority, 57
frequency of FDA actions, 136
as indicator of product safety, 135–137, 192
international comparison, 173
limitations of recall data, 135–137, 192
manufacturers’ reporting responsibilities, 53
orthopedic registries for, 140–141
public awareness, 142–143
repair or replacement of defective devices, 58
Safe Medical Devices Act provisions for, 257–258
software problems as cause of, 156–159, 164, 184
types of regulatory actions, 134–135
Repackagers, 86
Research needs
for alternatives to 510(k) process, 11, 201
for development of regulatory framework, 8–9, 196–197
on effects of 510(k) process on innovation, 12, 195, 202–203
postmarketing surveillance, 9–10, 199–200
recommendations for analysis of medical device software, 13, 203
Restricted devices, 46–48, 226–227
Restrictions on sale or use of device, 65–66
Risk assessment
attributes of ideal regulatory system, 22
in classes of recall actions, 135
in classification of medical device types, 1, 2b, 31–32, 68, 191
in de novo application process, 116
device tracking requirements based on, 48–49
drug regulatory framework, 63
FDA administrative enforcement powers, 56–60
international comparison of device regulation, 178–179, 179t
plant inspections, 133–134
Risk Evaluation and Mitigation Strategy, 63, 65, 98
Sentinel Inititative, 63, 130–132
timely communication of findings, 67–68
See also Postmarket surveillance
Risk notification requirements, 57–58
S
Safe Medical Devices Act (SMDA) (1990)
changes in premarket review process in, 35, 249–251
design validation requirements, 103, 259
essential provisions, 2–3, 34–37
implications for innovation, 35–36
on postmarket surveillance, 125–126, 256–257
on preamendment Class III devices, 255–256
purpose, 34, 249
on removal and correction of devices, 257–258
review time requirements, 255
on substantial equivalence, 35, 36–37, 168–169, 191, 251–255
Safety and effectiveness of medical devices
classification of medical device types, 2b, 31–32, 217–219
concerns about premarket notification process, 15–16
current state of, 6, 16, 32, 39, 192, 193
definitions and measurement of, 18
design controls, 259
design of premarket notification clearance process and, 33, 39
FDA authority to manage emerging safety issues, 64, 66–67t
FDA authority to restrict use of approved devices, 65–66
General Accounting Office review of FDA oversight, 235–236
goals of medical-device regulation, 21
historical evolution of legislative requirements, 212, 220–221
international comparison of regulatory systems, 176, 177
preamendment devices, 6, 31, 32
rationale for postmarket surveillance, 123
reasonable assurance of, 18
recall data as indicator of, 135–137, 192
recommendations to improve, 8, 13, 196–197, 203–204
shortcomings of current data sources for, 6, 12, 143, 192, 193
software evaluations, 13, 162–164, 203–204
substantial equivalence as standard for clearance and, 5–6, 34–35, 36–37, 39–40, 88–89, 91, 190–191, 193, 210, 241, 243, 253–255, 262–265
use of de novo process for, 11, 201
See also Postmarket surveillance
Section 510(k). See Premarket notification (510(k)) clearance process
Section 522 surveillance, 132, 143
Seizure of violative products, 55
Sentinel Initiative, 63, 130–132, 198
Software
as basis for product recalls, 156–159, 164, 184
in combination products, 155
FDA guidance, 158
in networked information systems, 160
off-the-shelf, 156, 158
patches, 159
product lines, 156
recommendations for FDA regulation and guidance, 13, 203–204
research needs, 13, 203
significance of, in medical devices, 156
sources of risk in, 159–160
testing procedures, 159
trends in medical device technology, 164, 184
validation, 160–164
Special controls
application, 51, 104
in context of 510(k) clearance process, 51–52
legislative authority, 2–3, 2b, 4, 34, 50, 250–251
limitations, 51–52, 210
recommendations for modified de novo process pilot program, 11, 201
Split predicate devices, 92, 152–153
Standards in 510(k) review. See Performance standards
Stents, 99b
Substantial equivalence
chain of devices, 33, 35, 81, 88, 91, 118, 252–253
clinical application of general tool, 95–96, 118–119
clinical data in support of claim of, 107–109
conformity with standards as evidence of, 107
consistency and predictability of review process, 91, 96, 107, 109–112
decision tree, 93f
definition, 3b, 33, 34, 36, 87, 88, 223, 245, 251–252, 253–254
evidentiary requirements, 3, 36, 102, 104–109, 110–111, 268–269
FDA guidance documents on, 104–105, 252–253
findings of Center for Devices and Radiological Health, 24b
General Accounting Office review of FDA oversight, 235–236
innovation and, 168–169
“intended use” and “indications for use” in determination of, 92–96
legislative provisions, 2, 32–33, 34–35, 86–87, 223–224, 251–255
in premarket notification clearance process, 5, 86
rate of premarket clearance based on, 33, 36, 191–192, 230–231, 231t, 232t
recommendations for new regulatory
framework to replace, 8, 196–197
safety and effectiveness of devices
approved on basis of, 5–6, 36–37, 39–40, 88–89, 91, 190–191, 210, 241, 243, 253–255, 262–265
standard of noninferiority, 34–35, 88–89
utilization of, for approval of Class II devices, 4
See also Predicate devices
Summary Technical Document program, 182–183
Supreme Court review of 510(k) process, 36–37, 262–265
Surgical mesh, 16
T
Third-party review, 75–77, 77f, 78t, 267
Traction, 79
Training of device operators, 46–47
Transparency
industry perceptions of 510(k) process, 110, 171
innovation and, 7, 194
public awareness of recalls and public health notices, 142–143
strategies to improve, 23, 77–78, 92
Transparency Initiative, 142–143
U
Unique device identifiers, 132–133, 141, 143, 172
User fees, 3, 29, 38–39, 40, 69, 70, 74, 199, 272–273
W
Warning letters, 134
@work toolset, 79