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



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