HUD Questions

Question 1

WHICH FDA AGENCY PROVIDES THE HUD DESIGNATION AS PREREQUISITE?
A. OOPD
B. CDRH
C. CBER

Answer 1

A) OOPD, Office of Orphan Product Development

Question 2

WHAT TIMEFRAME IN CALENDAR DAYS WILL THE OOPD WILL APPROVE THE REQUEST, REQUEST ADDITIONAL INFORMATION, OR DISAPPROVE THE REQUEST?
A. 30 DAYS
B. 40 DAYS
C. 45 DAYS

Answer 2

C. 45 DAYS

Question 3

HUD DESIGNATION CAN BE USED FOR:
A. a rare disease or condition
B. a specifically identified orphan subset of a non-rare disease
C. a specifically identified orphan subset of a non-rare condition
D. a rare disease or condition OR a specifically identified orphan subset of a non-rare disease or condition

Answer 3

D. a rare disease or condition OR a specifically identified orphan subset of a non-rare disease or condition

Question 4

IF THE POPULATION ESTIMATE IS THE NUMBER OF NEW PATIENTS PER YEAR DIAGNOSED WITH THE RELEVANT DISEASE OR CONDITION AND ELIGIBLE FOR TREATMENT WITH THE DEVICE, WHAT IS CORRECT:
A. HUD device is for Therapeutic purpose
B. HUD device is for Diagnostic purpose
C. HUD device is for both Therapeutic and Diagnostic purpose

Answer 4

A. HUD device is for Therapeutic purpose

Question 5

IF THE POPULATION ESTIMATE THE NUMBER OF PATIENTS PER YEAR WHO WOULD BE SUBJECTED TO DIAGNOSIS WITH THE DEVICE, REGARDLESS OF WHETHER THE TEST RESULT IS POSITIVE OR NEGATIVE, WHAT IS CORRECT?
A. HUD device is for Therapeutic purpose
B. HUD device is for Diagnostic purpose
C. HUD device is for both Therapeutic and Diagnostic purpose

Answer 5

B. HUD device is for Diagnostic purpose

Question 6

IN ORDER TO QUALIFY FOR HUD DESIGNATION, THE NUMBER OF PATIENTS SUBJECTED TO THE DEVICE MUST BE NOT MORE THAN 8,000 PATIENTS PER YEAR. Can this 8000 number include all new patients diagnosed with the disease or condition as well as existing patients with the disease or condition surviving from previous years?
True/False?

Answer 6

True

Question 7

A DEVICE IS USED TO SCREEN ALL NEWBORN BABIES TO IDENTIFY CERTAIN SERIOUS OR LIFETHREATENING CONDITIONS BEFORE SYMPTOMS BEGIN, THIS IS A SERIOUS LIFETHREATENING DISEASE OR CONDITION.
Can this diagnostic device qualify for a HUD ?
A. Yes
B. No

Answer 7

B. NO

Even if the serious lifethreatening disease or condition ultimately affects not more than 8,000 patients in the United States per year, the diagnostic device would not be eligible for HUD designation because the number of newborn babies subjected to the screening test would exceed the not more than 8,000 patient per year limit.

Question 8

IF THERE ARE 3,000 INDIVIDUALS WITH A GIVEN DISEASE OR CONDITION WHO WOULD EACH USE (ON AVERAGE) A GIVEN DEVICE FOUR TIMES PER YEAR, CAN THIS DEVICE MAY STILL BE ELIGIBLE FOR HUD DESIGNATION.
True/False?

Answer 8

A. True

HUD designations for diagnostic devices depend on the total number of new patients subjected to diagnosis by the device in a given year, not on the total number of devices expected to be used in a given year.

Question 9

HUD DESIGNATION FACILITATES:
A. the pathway to market for devices truly designed for small populations
B. devices eligible for exemption from the reasonable assurance of effectiveness requirement.
C. Both the above

Answer 9

C. both the above

Question 10

FACTORS THAT MAY INFORM WHETHER AN APPROPRIATE ORPHAN SUBSET EXISTS FOR THIS PURPOSE INCLUDE THE FOLLOWING INHERENT PROPERTIES OF A DEVICE:
A. Mechanism of Action of the Device
B. Adverse Event Profile
C. Other Clinical Experience with the Device
D. All the above

Answer 10

D. All the above

Question 11

IF THE FOLLOWING CONDITION EXISTS CAN THE ORPHAN SUBSET OF THE HDE PROVISION BE USED?

• Sponsor’s Plan to Study the Device for a Select Indication
• Unmet Medical Need

Yes/No?

Answer 11

Yes