MethodSense is a life science consulting firm, specializing in helping companies bring medical and technological products to market. This 510(k) Infographic was developed to help medical device companies bring products that contain software components or are composed solely of software to market effectively.

1. your device
equivalent?
equivalent?
Documentation
Decide on the e-Copy
submission format
Title all material following
e-Copy guidelines
PDF all material
YOU MADE IT!
Upload to FDA website
Burn CD with FDA e-Copy
output
Label CD, label binder(s)
Enclose CD in the binder
Properly prepare your documentation:
*
11 pt Arial is not a strict rule for the FDA, any clear, easy-to-read
font in 10 pt or higher is acceptable.
CDRH Premarket Submission Review Cover Sheet
Medical Device User Fee Cover Sheet
FDA Form 3514
510(k) Cover Letter
Pt. Arial
11*
Left Margin
1.5”
Other Margins
1.0”
Keep evidence
of the receipt
Class III Summary
& Certification
Applicable to Class III
Devices. If not relevant,
identify as ”NA.”
Software Requirement Specifications
Traceability Analysis
Software Design Specifications
Include an Architecture
Design Chart.
A summary is needed for Minor Level of Concern
Software. The Complete Software Requirement
Specifications is needed for Moderate and Major
Levels of Concern.
Software Development Life Cycle
Documentation
Required for software that are of Moderate or Major
Levels of Concern.
This traceability is performed among requirements,
specifications, identified hazards and mitigations,
and verification and validation testing.
If not relevant, identify as ”NA.”
Moderate MajorMinor
Sterilization Shelf Life
If not relevant,
identify as ”NA.”
If not relevant,
identify as ”NA.”
Table of Contents & List of Attachments
Make sure the hard copy and e-Copy
table of contents match.
Substantial Equivalence Discussion
Research and identify the device that
will be used for Substantial Equivalence.
Create a comparison matrix where you
identify the similarities and differences
between the client device and
the equivalent device.
Include at least the
following items:
q Intended use
q Indications for Use
q Target Population
q Main device hardware component(s)
q Energy
q Software, if appropriate
1
2
Proposed Labeling
14
15
17
Performance Testing
q Bench
q Animal
q Clinical
21
22
Revision Level History
Describe the major changes to the software during the
development cycle, including date, version number,
and a brief description of the changes.
25
23 24
Operating Manual(s)
Standards Data Report(s)
for 510(k) (FORM FDA 3654)
30
31
32
Electromagnetic Compatibility
Electrical Safety
18
3
Premarket Notification Truthful
& Accuracy Statement
Must be signed by Executive
Management or other
authorized person 7
Indications for Use Statement
510(k) Summary
5
6
8
Declarations of Conformity
& Summary Reports
Executive Summary
Device Description
12
13
11
10
510(k) Statement for
Predicate Product
Hazard Analysis
20
19
4
Complete payment online
with a focus on medical devices that contain software
components or are composed solely of software
+
+
+
Financial Certification &
Disclosure Statement
If not relevant, identify as ”NA.”
9
Biocompatibility
If not relevant, identify as ”NA.”
16
Software Level of Concern
Determine the Level of Concern based on the
questions provided by the FDA Guidance for the
Content of Premarket Submissions for Software
contained in medical devices.
Placed on your company
letterhead & signed by Executive
Management or other authorized person
Validation Plan(s)
Verification Report(s),
if applicable
Validation Report(s)
29
26
27
28Safety Test
Report(s)
75%
50%25%
MethodSense is a life science consulting firm, specializing in helping companies bring medical and technological products
to market. They guide medical device, biotech and pharmaceutical companies with quality, regulatory and technology
solutions, which enable clients to operate more effectively during the commercialization process and beyond. In addition to
their expertise as regulatory consultants, MethodSense has developed a 21 CFR Part 11 compliant software as a service tool,
InfoStrength Smart Enterprise Suite, that allows them to guide their clients to success. For more information about
MethodSense, please visit www.methodsense.com.
Please note: The above is not intended as regulatory advice for any particular medical device. Manufacturers should consult
with their regulatory affairs professional to determine the appropriate regulatory roadmap for your particular medical device.
510(k) Action List