3500 A

Question 1

What Types of FDA Regulated Products Can You Report Through MedWatch?

Answer 1

• Prescription and over-the-counter meds.
• Biologics
• Medical devices
• Combination products
• Special nutritional products
• Cosmetics
• Food

Question 2

When is a Malfunction considered to be reportable?

Answer 2

A malfunction is reportable when it is likely to cause or contribute to a death or serious injury if it were to recur.

Question 3

What goes in Section A?

Answer 3

PT Information

Question 4

What information goes in Section B?

Answer 4

Information about the Adverse Event and/or Product Problem.

Question 5

What constitues a serious injury as defined in 21 CFR 803.3

Answer 5

A serious injury or illness, as defined by 21CFR 803.3, meets one of these criteria:
- Is life-threatening
- Results in permanent impairment of a body function or permanent damage to a body structure
- Necessitates medical or surgical intervention to preclude or correct any permanent damage or impairment of a body function or structure.

Question 6

What’s the format that dates must be entered on the form?

Answer 6

DD-MMM-YYYY
- E.X.: 07 JUL 2023

Question 7

What two functions does MedWatch provide?

Answer 7

• MedWatch provides a platform to report Adverse Events and Product Problems
• MedWatch also provides updated informaiton related to the medical product for providers and the public

Question 8

In what instance does the Original Equipment Manufacturer [OEM] cease to be the manufacturer of a device?

Answer 8

When a Single-Use device has been reprocessed for re-use, either by a reprocessor or by a Hospital or Health Care Facility.

Question 9

What is a Combination Product?

Answer 9

A product in which a medical device is used to administer a drug [RX or OTC], nutritional product, or biologic.
- EX: metered-dose inhalers, nasal spray, prefilled syringe, auto-injectors, dialysis machines.

Question 10

Regarding MDR sections, what is the difference between MDR’s for a Medication [RX or OTC], and a medical device?

Answer 10

• Adverse Drug Event is the same 3500 form, but section C is filled out, as opposed to section D, which is for medical devices.

Question 11

Which standard/regulation pertains to Medical Device Reporting?

Answer 11

FDA 21 CFR Part 803

Question 12

Which standard/regulation deals with complaint handling?

Answer 12

FDA 21 CFR Part 820.198

Question 13

What is a Mother-Infant/Fetus Report?

Answer 13

those cases in which either a mother or a fetus/breast feeding infant, or both, sustain an adverse event that the initial reporter considers possibly associated with a product administered to, or a device used on the mother during pregnancy.

Question 14

When ONLY the infant/fetus has an adverse reaction/event (other than fetal death, miscarriage or abortion), the information provided in section A applies to the ______?
However, the information in section C or D would apply to the ________?

Answer 14

When ONLY the infant/fetus has an adverse reaction/ event (other than fetal death, miscarriage or abortion), the information provided in section A applies to the infant/ fetus. However, the information in section C or D would apply to the mother who was the source of exposure to the product or device.

Question 15

For those cases describing fetal death, miscarriage or abortion, who is reported as the patient in the report?

Answer 15

For those cases describing fetal death, miscarriage or abortion, report the mother as the patient in the report [In Section A]?

Question 16

When a newborn baby is found to have a congenital anomaly/birth defect that the initial reporter considers possibly associated with a product administered to, or device used on the mother during pregnancy, who is considered the PT being reported on?

Answer 16

When a newborn baby is found to have a congenital anomaly/birth defect that the initial reporter considers possibly associated with a product administered to, or a device used on the mother during pregnancy, the patient is the newborn baby.

Question 17

If both the mother and the infant/fetus sustain adverse events, how many reports should be filed?

Answer 17

If both the mother and the infant/fetus sustain adverse events, two reports should be provided and linked using the narrative field in block B5.

Question 18

What is Section E? What goes in Section E?

Answer 18

• Section E: Initial Reprter
• Information on who initially reported the adverse event to the user facility, importer, or device manufacturer.

Question 19

What does code FDA 21 CFR 803 outline?

Answer 19

FDA21 803 oultines the requirements for medical device reporting

Question 20

What does FDA 21 CFR 820.198 outline?

Answer 20

FDA 21 CFR 820.198 deals with complaint handling

Question 21

What’s the European equivalent to the FDA’s 21 CFR 820.198?

Answer 21

ISO 13485