National Academies Press: OpenBook
« Previous: Appendix B: Committee Biographies
Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

Index

[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

Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

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

Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

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

Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

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

Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

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

Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

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

Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

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

Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

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

Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

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

Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

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

Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

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

Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

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

Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×
Page 287
Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×
Page 288
Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×
Page 289
Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×
Page 290
Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×
Page 291
Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×
Page 292
Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×
Page 293
Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×
Page 294
Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×
Page 295
Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×
Page 296
Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×
Page 297
Suggested Citation:"Index." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×
Page 298
Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years Get This Book
×
Buy Paperback | $65.00 Buy Ebook | $54.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market.

At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!