Table of Contents |
Chapter
|
Title
|
Page
|
| 1
|
Medical Devices |
1
|
|
2
|
The Laws in General |
2
|
|
3
|
Prohibited Acts |
3
|
|
4
|
Device Registration and Listing Requirements
|
5
|
|
5
|
Imports
|
6
|
|
6
|
Exports
|
7
|
|
7
|
Interstate Shipments
|
8
|
|
8
|
Classification of Devices
|
9
|
|
9
|
Pre-market Notification [510(k)]
|
12
|
|
10
|
Pre-market Testing and Approvals
|
17
|
|
11
|
Good Manufacturing Practice Regulation
(21 CFR 820 - Quality System Regulation)
|
18
|
|
12
|
Medical Device Reporting
|
19
|
|
13
|
FDA Recall Authority
|
20
|
|
14
|
Tracking Requirements
|
21
|
|
15
|
Removal or Correction
|
22
|
|
16
|
Post-market Surveillance
|
23
|
|
17
|
Banned Devices
|
24
|
|
18
|
Investigational Device Exemptions
|
25
|
|
19
|
Humanitarian Devices
|
26
|
|
20
|
Custom Devices
|
27
|
|
21
|
Pre-market Approval (PMA)
|
28
|
Medical Device Regulation Basics