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7 Common 510(k) Mistakes and How to Avoid Them

Sep 29, 2022
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1
Introduction
00:00 • 2min
2
Seven Common Mistakes That Sync 510 K Clearances
01:35 • 2min
3
Is Your 510 K Submission Screwed Up?
03:14 • 2min
4
510 K Submissions Are Rejected Because of the High Level Labeling
05:28 • 3min
5
What's the Difference Between Indications for Use and Intended Use?
08:49 • 5min
6
The FDA Refusal to Accept (RTA) Checklist
13:40 • 2min
7
You Have to Chew FDA's Food for That
15:26 • 3min
8
Is a 510k a Workhorse?
18:24 • 5min
9
The Shelf Life of Medical Devices
23:02 • 3min
10
Accelerate Shelf Life Testing
25:39 • 5min
11
Do You Know What Shelf Life Is?
30:27 • 2min
12
Design Control Best Practices for Medical Device Product Risk Management
32:12 • 2min
13
The Risk Management of 510 K's
33:50 • 3min
14
Using a 510k Submission to Compare Substantial Equivalence to a Predicate Device
37:19 • 4min
15
What Is Substantial Equivalence in a 510 K?
41:37 • 2min
16
510 K Submissions Are Rejected on Administrative Review
43:29 • 2min
17
Do You Know How to Write a RTA Checklist?
45:33 • 4min
18
Getting Someone's Eyeballs on a 510 Case Mission
49:06 • 2min
19
Is There a Shelf of Life to Medical Devices?
51:11 • 2min
20
Medical Device Industry Is Nothing Unless It Works the Same Way
53:10 • 2min