FOREWORD
PREFACE
ABSTRACT
1. INTRODUCTION
2.1 Why did Congress require device user facility reporting?
2.2 What is a “device user facility”?
2.3 Who must report and where are the reports directed?
2.4 Does a facility need to designate a contact person?
2.5 Under the tentative final rule, what written procedures are required of device user facilities?
2.6 Should facilities still submit reports through the United States Pharmacopeia's (USP) Problem Reporting Program (PRP)?
2.7 When are comments due for consideration in the final regulation?
3.1 What is the relationship between Medical Device Reporting and user facility reporting?
3.2 What is an “MDR reportable event” under the tentative final rule?
3.3 What does “information that reasonably suggests that there is a probability that a device has caused or contributed to a death or serious injury or serious illness” mean?
3.4 What does “probability” mean?
3.5 What constitutes “serious illness or serious injury”?
3.6 What does “permanent” mean?
3.7 What does “necessitates immediate medical or surgical intervention” mean?
3.8 What does “device” mean?
3.9 Who is considered to be a “patient”?
3.10 What does “affiliated” mean?
3.11 Who is responsible for notifying the designated person within a facility of a possible MDR reportable event?
3.12 What does the term “medical personnel” include?
3.13 Are incidents arising from user error reportable?
3.14 How should a determination be made about a “reportable event” if the facility is unsure about the association of a device with such an event?
3.15 Under what circumstances is a medical device report not required?
3.16 What is a “working day”?
3.17 Who is exempt from reporting?
4.1 What is confidential?
4.2 Can the patient's identity be protected?
4.3 Can reports submitted to FDA under these new reporting requirements be used as evidence in a civil action?
5.1 What is the effective date of the user facility reporting requirements?
5.2 What should a reporting system include?
5.3 Can FDA request more information about an event after it is reported?
5.4 What types of reports are required of user facilities?
5.5 Is a semiannual report required if a device user facility has submitted no reports for that period?
5.6 What is the time frame for submitting reports and where should they be sent?
5.7 Will a form be used and will instructions accompany it?
5.8 What is a user facility report number?
5.9 What files must be maintained by user facilities and for how long?
6.1 What authority does FDA have to enforce these provisions?
7. KEY WORD INDEX