ABSTRACT
Introduction ....................................................................................................... 126 Is It a Device? ................................................................................................... 128
Product Jurisdiction ...................................................................................... 128 Types of Medical Devices ............................................................................ 129
Medical Device Classification .......................................................................... 129 Determining Device Classification............................................................... 130 Reclassification ............................................................................................ 132
An Introduction to the Medical Device Approval Process ................................ 135 Strategic Choices .......................................................................................... 135 Modification of Marketed Devices ............................................................... 136
Design Controls ................................................................................................ 137 The Difference between Research and Development .................................. 137 Design Control Components ........................................................................ 138
Medical Device Clinical Research .....................................................................141 Exempted Studies ......................................................................................... 142 Nonsignificant Risk Studies ......................................................................... 142 Significant Risk Studies ............................................................................... 144 The Investigational Device Exemption ........................................................ 144 Unique Aspects of Medical Device Studies ................................................. 144
The 510(k) Premarket Notification ................................................................... 146 Substantial Equivalence ................................................................................147 Types of 510(k)s ........................................................................................... 148
Traditional 510(k) .................................................................................... 148 Abbreviated 510(k) .................................................................................. 148 Special 510(k).......................................................................................... 150 De Novo 510(k) ....................................................................................... 150
510(k) Components ...................................................................................... 150 The Cover Sheet (Form FDA 3514) ........................................................ 150 The Cover Letter...................................................................................... 150 The Table of Contents ............................................................................. 151 User Fee Information............................................................................... 151 Form FDA 3654 ...................................................................................... 151 Statement of Substantial Equivalence ..................................................... 151
Since the technological advances of the 1950s and 1960s, the rate of innovation in the medical device industry has greatly accelerated. These innovations have led to very substantial therapeutic, monitoring, and diagnostic benefits in all areas of medicine. Often, these innovative devices were selected and used by health-care professionals who received their basic scientific training before these technologies were developed. By the early 1970s, many medical devices were becoming so complex that medical professionals were no longer able to fully assess their
Labeling ................................................................................................... 151 Advertising and Promotional Material .................................................... 152 Comparative Information ........................................................................ 152 Biocompatability Assessment (If Necessary) .......................................... 152 Truthful and Accurate Statement ............................................................. 153 Clinical Data ............................................................................................ 153 Shelf Life (If Necessary) ......................................................................... 153 Indication for Use Form .......................................................................... 153
510(k) Summary........................................................................................... 154 Practical Aspects for 510(k)s ....................................................................... 154 Postsubmission Considerations for 510(k)s ................................................. 155
The PMA Application ....................................................................................... 155 Introduction to the PMA .............................................................................. 155 The PMA Process ......................................................................................... 155 User Fee ....................................................................................................... 156 Advisory Panels ........................................................................................... 156 Clinical Data................................................................................................. 157 Use of International Data ............................................................................. 157 Components of the PMA .............................................................................. 158
The Quality System Regulation ........................................................................ 159 Design Controls ............................................................................................ 159 Management Controls .................................................................................. 160 Corrective and Preventive Action ..................................................................161 Production and Process Controls ................................................................. 163
Postmarketing Issues ......................................................................................... 163 Registration and Listing ............................................................................... 163 Medical Device Modifications ..................................................................... 163 Modifications to 510(k) Devices .................................................................. 164 Modifications to PMA Devices .................................................................... 164 Medical Device Reporting ........................................................................... 165 Unique Device Identification ....................................................................... 166 Advertising and Promotion .......................................................................... 167
References ......................................................................................................... 167
attributes. Device developers and manufacturers were also encountering situations where devices interacted with the body in unanticipated ways or deficiencies in the production process led to patient injuries and deaths. In the United States, this history was the driving force behind the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1938. By 1978, when the regulations required by this new law came into full effect, the production and clinical testing of medical devices were subject to the Food and Drug Administration (FDA) review. Many new devices entering the US market had to undergo the FDA review, either through the 510(k) premarket notification process or the premarket approval (PMA) process. The 1976 Amendments have been modified several times over the years and now also cover the device development process. This chapter provides an introduction to medical device classification, the preparation of premarket submissions, medical device clinical research, and manufacturing regulations.
