Definitions

Question 1

Medical Device

Answer 1

An apparatus, implant, In vitro reagent, including any component or accessory intended for the diagnosis, mitigation, treatment of prevention of disease or intended to affect the structure or function of the body. It does not achieve its primary intended purposes through chemical action within/on the body and is not intended to be metabolized in the body.

Question 2

Centre for Device Radiological Health (CDRH)

Answer 2

Charged with the most medical device oversight

Responsible for ensuring the safety and effectiveness of medical devices eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products.

Question 3

Foods and Drug Administration (FDA)

Answer 3

Oversees manufacturing and distribution of food, pharmaceuticals, medical devices, tobacco and other consumer products and veterinary medicines.

Question 4

Premarket Notification

Answer 4

A 510K is a submission made to the FDA to demonstrate the device which needs to be marketed is as safe and effective, that is, substantially equivalent (SE) to a legally marketed device (predicated device) that is not subject to premarket approval.
90 days to make approval.

Question 5

Substantial Equivalence

Answer 5

Means the new device is as safe and effective as predicated devices

Question 6

A device is substantially equivalent when:

Answer 6

1. )same intended use as the predicate device
2. )same technological characteristics as predicate device
3. )has different technological characteristics that don’t raise new questions over the safety and effectiveness of said device, and sponsor demonstrates its as safe and effective as the predicate marketed device.

Question 7

Pre-clinical Testing

Answer 7

The FDA doesn’t publish a specific list of tests required for a regulatory submission. Rather place the burden on the manufacturer to provide evidence the device is both safe and efffective.

Question 8

Contents of PMN (4)

Answer 8

1. ) Device description
2. ) Substantial equivalence
3. ) Labelling
4. ) Performance data

Question 9

Premarket Approval

Answer 9

The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
Class III- general and special controls are insufficient.
180 days are given to FDA to review.

Question 10

Classification

Answer 10

Class I:
Devices which pose little to no risk to humans.(Bandage, tongue depressor.)
Class II:
Devices that pose some risk to the user and usually requires a PMN/510K. Subjected to performance standards (Wheelchair, Hearing aids.)
Class III:
Involved in the sustaining of human life/support-therefore posing a high risk to human life

Question 11

IDE

Investigational Device Excemption.

Answer 11

Allows the use of the investigational device to be used in a clinical study in order to collect safety and effectiveness data.

Question 12

Process of FDA Approval.

Answer 12

FDA notifies the applicant its decision Federal Register Notice (FRN) announces the decision and the availability of the summary of a safety and effectiveness data on which the data is based.

Question 13

GMP

Goods Manufacturing Practice

Answer 13

GMP is an quality assurance system similar to ISO 13485
Designed to give manufacturers control over any process variables critical to performance of the product s well as routine practices to maintain performance of personnel/equipment

Question 14

GMP requires:

Answer 14

Written procedures for evaluation and sterilization of final products as well as for maintenance of records for the manufacture and shipment of each batch of product.

Question 15

First step to obtaining marketing clearance from CDRH

Answer 15

1.)Ensure product to be marketed is a medical device, by making sure it meets the definition of the FD&C Act.

Question 16

Second Step

Classify Device

Answer 16

2.) Determine FDA classification. Classification identifies level of regulatory control that’s necessary to assure the devices safety and effectiveness.

Question 17

Third Step

Selecting appropriate marketing application

Answer 17

3.) Development of information and data necessary to submit a marketing application and obtain FDA approval. Clinical performance data is required with most 510K/PMA applications. Conduction of a trial via IDE regulation.