US Pre-Market Submission

Question 1

True or False?

An mobile application (App) can be a medical device?

Answer 1

True.

Question 2

True or False?
The United States follows the conventional international Rules for classification with a few country specific modifications?

Answer 2

False.
The US uses a risk based classification that only includes three class, I, II, & III. Classification is not only based on what the device does (intended use), but also on what the device will be used to do (indications for use). Ex. Scalpel to cut tissue - Class I. Scalpel marketed and sold to cut eye tissue - Class III.

Question 3

True or False?

A Novel low or moderate risk device (one that has no predicate) will still be approved using traditional 510(k).

Answer 3

False.

The FDA created a special process for low-to moderate risk devices, the De Novo process.

Question 4

True or False?

All Class I devices are exempt from pre-market submissions?

Answer 4

False.
Most class I devices are exempt, but some low risk devices require a 510(k).

Question 5

Which of the following are used for requesting information about classification?:
A)510(k)
B)Q-Submission
C)Pre-Market Approval
D)513(g)

Answer 5

The Answer is D.

the 513(g) is used to submit a classification determination and regulatory information from the FDA.

Question 6

True or false?

Some Class III devices can be approved via a 510(k) submission.

Answer 6

False.

All Class III devices require a PMA.
Class II devices range from exempt(very few), to 510(k) to De Novo.
Class I devices are mostly exempt from premarket submissions, but may require a 510(k), depending on the device.