Reporting Timelines

Question 1

510k Premarket notification

Answer 1

The sponsor notifies the FDA 90 days before selling the device

Question 2

A significant risk device investigation completion notification

Answer 2

Must be reported to the FDA by the sponsor within 30 working days, and an initial report submitted to the FDA, IRBs, and sites within 6 months (this report if or NSR devices also)

Question 3

“Active protocol”

Answer 3

Defined as any protocol the IRB has reviewed within the last 12 months

Question 4

Annual Reports

Answer 4

Must notify the FDA within 60 days of the IND effective anniversary date, no initial report, the sponsor reports

Question 5

Clinical Trial Results Report-who notifies within

Answer 5

Sponsor notifies the FDA within 1 year

Question 6

Clinical Trials results-who sends when

Answer 6

The sponsor sends to the FDA & sites within 1 year after trial completion

Question 7

Deviation from protocol-important

Answer 7

Notify the FDA within 5 working days, no initial report, the site reports to the sponsor and IRB

Question 8

Device UADE reported to FDA, sponsor, and IRB

Answer 8

Notify the FDA within 10 working days, submit the intial report ASAP, reported by the sponsor

Question 9

Device used without consent reported to sponsor and IRB

Answer 9

Notify the FDA within 5 working days, no initial report, the site reports

Question 10

Emergency expanded access submission submitted after FDA’s authorization

Answer 10

Notify the FDA within 15 working days , no initial report, sponsor reports

Question 11

Emergency immediate use

Answer 11

Notify the FDA within 5 working days, no initial report, the site notifies

Question 12

Emergency immediate use IRB determinations-who keep for how long

Answer 12

The site must keep for 3 years after completion of the trial

Question 13

Emergency immediate use without independent determination -IRB notified

Answer 13

Notify the FDA within 5 working days, no initial report, the site reports

Question 14

Expanded access IND goes into effect

Answer 14

30 days after the FDA receives the IND as long as the FDA does not respond no or hold, the sponsor submits

Question 15

FDA terminates IND - sponsor response

Answer 15

The sponsor responds within 30 days

Question 16

FDA 483 sponsor response

Answer 16

Notify the FDA within 15 working days , no initial report, sponsor reports

Question 17

FDA approval or withdrawal

Answer 17

Notify the FDA within 5 working days, no intital report, the sponsor reports;

sponsor notifies IRB and investigators

Question 18

FDA determination after IND or IDE

Answer 18

The FDA will notify the sponsor within 30 days

Question 19

FDA follow-up inspections

Answer 19

The FDA follows up for 2 years after the initial inspection

Question 20

FDA notifies sponsor if they terminate IND

Answer 20

The FDA will notify the sponsor within 30 days

Question 21

FDA response to sponsor IND hold lift request

Answer 21

The FDA will notify the sponsor within 30 days after receipt

Question 22

Final report to sponsor and IRB

Answer 22

Within 3 months after study completion, from the site

Question 23

Findings from other animal studies - previously unknown significant risk

Answer 23

Notify the FDA within 15 calendar days, no initial report, reported by the sponsor

Question 24

Findings from other human studies - previously unknown significant risk

Answer 24

Notify the FDA within 15 calendar days, no initial report, reported by the sponsor

Question 25

HIPAA Privacy Rule - required to account for disclosures-must be kept

Answer 25

Must keep for 6 years from date of creation

Question 26

HUD

Answer 26

FDA will respond to request for HUD designation within 45 days and either approve, disppaprove, or return

Question 27

If an IND is inactive for how long, will it be grounds for termination

Answer 27

FDA will inactivate after 5 years

Question 28

IND can be inactivated if no subjects are enrolled after

Answer 28

1 year, the FDA will inactivate

Question 29

IND Clinical Hold Explanation to sponsor

Answer 29

The FDA will notify the sponsor within 30 days

Question 30

IND will be inactivated if on hold for

Answer 30

1 year, the FDA will inactivate

Question 31

IND withdrawal

Answer 31

Notify the FDA ASAP or upon completion of the study, no initial report, the sponsor reports

Question 32

IND withdrawal - due to Safety

Answer 32

Stop the study and notify the FDA within 5 working days, no initial report, the sponsor reports

Question 33

IRB contact or chair person changes

Answer 33

The site and sponsor notifies the FDA within 30 days

Question 34

IRB determines SR and sponsor does not

Answer 34

Notify the FDA within 5 working days, no intital report, the sponsor reports

Question 35

IRB Registration

Answer 35

-is effective for 3 years -must be updated within 90 days -report disbanding it must be submited within 30 days

Question 36

IRB suspension or termination

Answer 36

Notify the FDA promptly, no initial report, the IRB reports

Question 37

Misconduct Inquiry

Answer 37

Must be completed within 60 calendar days

Question 38

Misconduct Investigation

Answer 38

Must start within 30 days of inquiry completion

Question 39

New Investigator/Study Site

Answer 39

The sponsor notifies the FDA within 30 days

Question 40

New protocol info

Answer 40

The sponsor notifies the FDA within 30 days

Question 41

Progress Reports

Answer 41

The site sends to the sponsor & IRB, the sponsor to the IRB and FDA (for SR devices) no later than once per year

Question 42

Recall and device dispostion

Answer 42

The sponsor notifies the FDA within 30 days the sponsor notifies FDA and IRB

Question 43

SAE's that are fatal or life threatening

Answer 43

Notify FDA within 7 calendar days, submit the initial report within 8 additional calendar days, reported by the sponsor, notify investigators within 15 calendar days

Question 44

SAE's that are not fatal or life threatening

Answer 44

Notify the FDA within 15 calendar days, no intial report, reported by the sponsor to regulatory authorities and investigators

Question 45

Serious UADRs that are fatal or life threatening

Answer 45

Notify FDA within 7 calendar days, submit the initial report within 8 additional calendar days, reported by the sponsor

Question 46

Serious ADR with an increased rate

Answer 46

Notify the FDA within 15 calendar days, no intial report, reported by the sponsor

Question 47

Serious UADR's that are not fatal or life threatening

Answer 47

Notify the FDA within 15 calendar days, no intial report, reported by the sponsor

Question 48

Sponsor & investigator holds records for

Answer 48

2 years after marketing is approved or it becomes inactive (IRB is 3 years)

Question 49

Sponsor notifies FDA of change to IDE

Answer 49

Notify the FDA within 5 working days, no initial report, the sponsor reports

Question 50

Sponsor request for reg hearing

Answer 50

Notify the FDA within 10 days of sponsor receipt of FDA notification of nonacceptance of IND, no initial report, reported by the sponsor

Question 51

Sponsor submits to FDA investigator names

Answer 51

Every 6 months

Question 52

Sponsor submits to FDA investigator names

Answer 52

within 30 days of adding new PI for drugs

Question 53

Study will re-activate after a hold after the FDA has received an amendment

Answer 53

30 days after the sponsor submits the amendment

Question 54

Termination due to UAE

Answer 54

Notify the FDA within 15 working days of sponsor notification, no initial report, sponsor reports

Question 55

The FDA will give review a PMA within

Answer 55

180 days after the sponsor submits

Question 56

Transfer custody of record

Answer 56

notify the FDA within 10 working days after transfer, no initial report, reported by the sponsor

Question 57

UADE - unreasonable risk

Answer 57

Terminate within 5 working days after making determination; and notify the FDA no more than 15 working days after receiving risk notice, reported by the sponsor

Question 58

Unanticipated problems

Answer 58

Notify the FDA promptly, no intial FDA report, the site and sponsor report

Question 59

Updated FDF

Answer 59

Must be completed by the site 1 year after study completion

Question 60

Withdrawal IRB approval - report

Answer 60

Notify the FDA within 5 working days, no initial report, the site and sponsor reports site to sponsor and sponsor to FDA