Chapter 6: Medical Device Preclinical Testing

Question 1

Preclinical Testing covers both the ____ and ____ test suites to ensure a devices safety and initial efficacy

Answer 1

Preclinical Testing covers both the (in vitro) and (in vivo) test suites to ensure a devices safety and initial efficacy

Question 2

Although global regulatory authorities (FDA, EMA, MHRA, PMDA) have published numerous regulations, reflection papers, guidance documents, and information sheets defining GLP requirements…many industry standards for conducting both in-vivo and in-vitro experiments are generally considered ____ _________.

Answer 2

Although global regulatory authorities (FDA, EMA, MHRA, PMDA) have published numerous regulations, reflection papers, guidance documents, and information sheets defining GLP requirements…many industry standards for conducting both in-vivo and in-vitro experiments are generally considered (best practices).

Question 3

“Best practices” are based on ____ and ____, but are not found in the black letter of the regulations.

Answer 3

“Best practices” based on (regulations) and (guidance documents), but are not found in the black letter of the regulations.

Question 4

Pharmacodynamics (PD) is?

Answer 4

What the drug does to the body

Question 5

Pharmacokinetics (PK) is?

Answer 5

What the body does to the drug

Question 6

What does the acronym ADME stand for? (Types of preclinical testing)

Answer 6

“ADME”

Absorption, distribution, metabolism, excretion

Question 7

(T/F) Medical devices that do not have a drug attached need to undergo additional preclinical tests before moving to bench testing and validation.

Answer 7

No, they may go directly to bench testing and validation as part of design and development process.

Question 8

Preclinical studies are executed to test and verify the ____ ____ of a medical device, IVD, or regenerative medicine product

Answer 8

Preclinical studies are executed to test and verify the (intended performance) of a medical device, IVD, or regenerative medicine product

Question 9

Who developed GLP principles?

Answer 9

OECD (Organization for Economic Cooperation and Development)

Question 10

(T/F) GLPs are a data quality system and should not be confused with standards for laboratory safety

Answer 10

(True) GLPs are a data quality system and should not be confused with standards for laboratory safety

Question 11

A nonclinical laboratory study is an in-vivo or in-vitro experiment in which test articles are studied prospectively in test systems under laboratory conditions to determine ____.

Answer 11

A nonclinical laboratory study is an in-vivo or in-vitro experiment in which test articles are studied prospectively in test systems under laboratory conditions to determine (safety).

Question 12

All studies are expected to conform to GLP if they are intended to support applications for ____or ____.

Answer 12

All studies are expected to conform to GLP if they are intended to support applications for (human use) or (CE-marking).

Question 13

Human clinical studies are governed ____ ____ ____.

Answer 13

Human clinical studies are governed (Good Clinical Practices, GCP) and are thus outside the scope of this chapter

Question 14

Are initial proof-of-concept studies subject to GLP?

Answer 14

No, and are typically not used to support applications for human clinical research or marketing applications

Question 15

Important stages of Preclinical stages in Medical Device Development

Answer 15

1. Material Selection
2. Manufacturing Methods
3. Biocompatability Testing
4. Functionality/Performance
5. Packaging
6. Final processing (sterilization)

Question 16

Two clinical data routes for CE-marking?

Answer 16

1. Literature Route
   Commonly used by Mfg. for CE-marking (I, IIa, IIb)
   Safety and performance demonstrated by a combination of nonclinical data (bench, animal) and already existing clinical data
2. Clinical Investigation

Question 17

(T/F) Adequacy of preclinical testing (bench, animal studies) to verify safety is critical for clinical evaluation as per MEDDEV 3.7/1, Rev 4

Answer 17

False

MEDDEV 2.7/1, Rev 4

Question 18

(T/F) Each class of product must undergo the same types of preclinical testing, regardless of class

Answer 18

False, each class of product may undergo different types of preclinical testing

Question 19

The amount of preclinical testing is commensurate with it’s potential risk to ____ ____.

Answer 19

The amount of preclinical testing is commensurate with it’s potential risk to (human health).

Question 20

Preclinical Testing is critical to the medical device lifecycle, as it is the stage in which ____ ____ is set, including functionality and safety aspects, and selected materials and processes validation begins.

Answer 20

Preclinical Testing is critical to the medical device lifecycle, as it is the stage in which (product design) is set, including functionality and safety aspects, and selected materials and processes validation begins.