1 510 (k) Guidance Document

Guidance document on
the FDA 510 (k)
Submission

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 2 510 (k) Guidance Document

Table of Contents
1. Introduction ............................................................................................................................. 3
2. What is 510 (k)? ...................................................................................................................... 3
3. What is a predicate device?..................................................................................................... 4
4. What is substantial equivalence? ............................................................................................ 5
5. Who needs to Submit a 510(k)? .............................................................................................. 5
6. Eligibility criteria for 510(k) clearance................................................................................... 6
7. Types of 510 (k) ...................................................................................................................... 7
8. Submission Pathway for 510 (k) ............................................................................................. 9
9. Documents required ............................................................................................................. 12
10. Mistakes to avoid while preparing for 510 (k)..................................................................... 14
11. Conclusion ........................................................................................................................... 15

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 3 510 (k) Guidance Document

1.Introduction
hrough the 510(k) pathway, the Third-party review organizations have
Food and Drug Administration fulfilled a specific role in aiding in evaluating
(FDA) approves about 3,000 510(k) applications for a list of specified
medical devices for marketing each year. device classes for more than 25 years. All
Including the premarket evaluation of companies wishing to introduce a medium-
numerous devices integrating more recent risk medical device into the American market
technologies like artificial intelligence (A.I.), must go through the FDA's 510(k)
machine learning (ML), and other software, submission process, essentially a clearance
these make up 99 percent of all devices process. Nearly half of all medical devices
authorized for human use. The volume and used daily in the United States have
complexity of device reviews have increased undergone the 510(k) process.
due to statutory changes like the 21st Approximately 3000 510(k) submissions
Century Cures Act, regulations, and guidance were received annually; however, 30% of
documents, as well as the anticipated 2022 submissions were selected for
growth in complexity and number of preliminary review. Medical device
applications in the upcoming years. professionals may find the lengthy and
Therefore, optimizing the 510(k) pathway's intricate process daunting, so we've
review process for less complicated, low-to- compiled all the information you require
moderate-risk devices will enable the FDA to about the FDA's 510(k) submission process.
focus on other significant, forward-looking
regulatory issues.

2.What is 510 (k)?

An FDA premarket submission is called a Medical device manufacturers can apply
510(k). Because it refers to that section of under the 510(k) regulatory pathway to
the Food, Drug, and Cosmetic Act, it is known obtain FDA approval to market an eligible
as a 510(k). This regulatory route is primarily product in the United States. A medical
used for Class II devices that aim to be device manufacturer that wants to use the
functionally and substantially identical to 510(k) pathway must submit a premarket
another legally marketed device. Without notification to the FDA with details about the
requiring a premarket approval (PMA) device's intended use, design, and
submission, the device may be sold performance characteristics compared to a
immediately if the FDA certifies that it is predicate device. Proving that a device is
substantially equivalent. In most 510(k) "substantially equivalent" to one that has
submissions, the FDA does not require already received FDA clearance and is being
clinical data; however, in certain sold commercially is the aim of the 510(k)
circumstances, the FDA may ask for clinical submission. They call this a "predicate
data to verify substantial equivalency. device." The FDA evaluates the 510(k)
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submission to determine whether the device predicate device. It's crucial to understand
is equivalent to the predicate and functions that FDA clearance under the 510(k)
as intended. The FDA will issue a clearance pathway means the FDA has found the
letter enabling the manufacturer to market device comparable to an existing, similar
the device in the U.S. Once it has concluded product on the market, not that the FDA has
that it is substantially equivalent to a approved it.

3.What is a predicate device?

In a 510(k) submission, a predicate device is used to show the safety and efficacy of the new
device that will be marketed.

This is accomplished by demonstrating a • Devices classified as preamendments are

significant equivalency between the new those that were lawfully sold in the
and predicate devices. The predicate device United States before May 28, 1976, have
must be a legitimately sold product not undergone substantial modification,
approved through a 510(k) submission, with and for which the FDA still needs to
proof of equivalency. Preference should be publish a regulation requiring a PMA
given to devices currently on the market in application.
the United States and obtaining 510(k)
clearance relatively recently when choosing • Devices are no longer marketed in the
a predicate device. United States, either as preamendment
or post-amendment devices. In this
• Post amendments devices, or devices instance, a device that violates the FD&C
marketed after May 28, 1976, are Act cannot be the predicate device.
examples of precedent devices. Most
510(k) applications are significantly like a
post-amendment device.

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4.What is substantial equivalence?

The 510(k) requires evidence of substantial equivalency to another legally marketed device in
the United States. Significant equivalency denotes that the new device is equally reliable and
safe as the predicate.

If a device is substantially equivalent to a predicate, then it is:

• Either shares the same technological The FDA first confirms that the intended uses
features and is intended for the same of the new and precedent devices are the
purpose as the predicate or same, and any variations in technological
features do not give rise to new concerns
• It shares the predicate's intended use but regarding their efficacy and safety. The FDA
then examines the scientific procedures
• It differs in its technological used to assess technical features and
characteristics and does not raise any new performance data variations to decide
safety or efficacy concerns; additionally, whether the device is as safe and effective as
the predicate device. Clinical and non-clinical
• The data provided to the FDA shows that bench performance data, such as those from
the device is as safe and effective as the engineering performance testing, sterility,
legally marketed device. The novel and electromagnetic compatibility, software
predicate devices do not have to be validation, and biocompatibility assessment,
identical for there to be a claim of are examples of this type of performance
substantial equivalency. data.

5.Who needs to Submit a 510(k)?

The FD&C Act and 21 CFR 807, the 510(k) regulation, outline which actions necessitate a 510(k)
submission, like bringing a device to the U.S. market.

The FDA requires the following types of parties to submit a 510(k):

a) Local manufacturer launching a product b) Devices introduced to the U.S. market

on the American market. If finished by specification developers - A
device manufacturers produce a product specification developer creates the
based on their specifications and sell it in specifications for a final product but
the United States, they must file a 510(k). contracts with a different company or
Devices sold as finished goods to the organization to manufacture the
consumer also include their accessories. product. The 510(k) is submitted by the
specification developer rather than the
contract manufacturer.

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c) Repackers or labelers whose operations changes, such as adding a new intended

significantly impact the device or whose use, the deletion or addition of warnings,
labeling changes - If repackagers or contraindications, etc. Sterilization is one
labelers materially alter the labeling or operation that could change the device's
otherwise modify any aspect of the state. Most relabelers or repackagers,
device's condition, they might need to however, are exempt from filing a
file a 510(k). Manuals may need to be 510(k).
adjusted to reflect significant labeling

6.Eligibility criteria for 510(k) clearance

A medical device needs to fulfill several requirements to be eligible for 510(k) clearance, which
we've listed and briefly discussed below:

•Level of Device Risk

•Device Type
Eligibility criteria •Device History
•Device Characteristics
•Substantial Equivalence

a) Level of Device Risk: The FDA has • Most Class II and a few Class I devices
developed three levels of oversight are classified as medium-risk devices
based on each device's risk level to (510(k)).
balance efficiency and safety. Devices • Class III devices that sustain or support
exempt from premarket submission fall life, are implanted, or pose an
into the first level, low risk. Premarket unreasonable risk of disease or injury
Notification, or 510(k), represents the are considered high-risk devices
second level of risk, which is medium. (premarket approval).
Premarket Approval (PMA) represents
the third level of risk, which is high.

• Premarket Notification is typically not

applicable to low-risk devices, which
include most Class I and some Class II
devices.

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b) Device Type - The 510(k)-clearance d) Device Characteristics - The device must

procedure does not apply to all devices. be made in compliance with 21 CFR 820
For instance, 510(k) clearance is not Quality System Regulation (QSR) and
available for custom devices, devices cannot unreasonably endanger the
meant for investigational use, or devices public's health or safety. Additionally,
intended to be used as parts of another the device must adhere to any applicable
device. performance requirements, like those
set forth by international standards
c) Device History - The FDA cannot have organizations or the FDA.
previously recalled, outlawed, or placed
limitations on the device. The device's e) Substantial Equivalence – The device
application for premarket approval or must be "substantially equivalent" to a
510(k) clearance has been allowed. medical device that is legally marketed
and has previously received FDA
approval (referred to as a "predicate
device").

7.Types of 510 (k)

Three different 510(k) forms are available if the medical device meets the requirements for
premarket Notification: Traditional, Abbreviated, and Special.

Traditional 510
(k)

Abbreviated 510
Special 510 (k)
(k)

 Traditional 510 (k) - The Traditional 510(k) the point where it is no longer eligible for
pathway is used for any original device a Special 510(k). Predicate devices need
not previously cleared and is exempt from to be recognized based on their
the PMA process. technological characteristics and usage
• It is also used when a device that has patterns.
already received approval is modified to

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 Abbreviated 510 (k) - An alternative to the manufacturer's design control processes

conventional route was created as the for assessing the changes and
Abbreviated 510(k) program. Suppose the guaranteeing accurate results without
submission is based on voluntary consensus affecting the legal requirements for
standards, FDA guidance documents, or significant equivalency. The methods'
evidence of compliance with exceptional established nature and the ability to
control(s) pertinent to the device type. In adequately review results in a summary
that case, manufacturers may submit an or risk analysis format are what
abbreviated 510(k). regulators want to know.
• The same sections as in a traditional
510(k) submission must be included in an The FDA advises device manufacturers to
abbreviated 510(k) submission. think about the following essential factors
• However, manufacturers may add when deciding whether to pursue the
summary reports on guidance Special 510(k) program for a given device:
documents, special control compliance,
or standard conformance to show • Is the device made by the manufacturer
substantial equivalency. changing? A Special 510(k) is not the right
• Although it may not require as much course of action if not.
work, the abbreviated pathway may be an • Does the assessment of the change
option if employing a predicate device require performance data? The current
proves equivalency to a standard is more Special 510(k) guidance states that
complicated. manufacturers may submit changes as a
• Although it usually takes 90 days, the Special 510(k) with a clear justification for
Abbreviated 510(k) review period may their determination that no performance
take longer than the Traditional 510(k). data are required "in situations where
manufacturers decide, by their design
 Special 510 (k) - A manufacturers legally control protocols, that further validation
marketed precedent device that has already or verification testing is not required to
received approval for commercial assess a modification that would
distribution is the subject of the Special otherwise need to be submitted and
510(k) request. The original Special 510(k) approved by a 510(k)."
guidance was updated in the most recent • Is there a tried-and-true technique for
version to permit reviews of modifications assessing the modification? A Special
that impact a device's intended use or 510(k) is not the right course of action if
change the device's core scientific not.
technology. • Can a summary or risk-analysis format be
• Before this update, Special 510(k) used to review the data? A Special 510(k)
prohibited those modifications. The is not the right course of action if not.
FDA's new guidance emphasizes the

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8. Submission Pathway for 510 (k)

Step 1:
Determining
Step 5: FDA
the Predicate ‍Step 2: Building
510(k)
Device, a quality Step 3: Device Step 4: The
Database
Submission management testing wait
Listing and DA
Type, and system:
Clearance
Device Class
Code

After reviewing the FDA 510(k) fundamentals, let's examine the submission procedure. Focusing
on just one predicate device, here are all the requirements to initiate 510(k):

Step 1: Determining the Predicate Device, equivalent to an already-marketed

Submission Type, and Device Class Code predicate.

Determine the product code and the • Intended use

regulation number. Finding the product code • Design
and regulation number is the first step in • Materials
figuring out the 510(k) test requirements. To • Safety
identify the seven-digit regulation number • Labeling
whose identification matches the intended • Performance considerations: engineering,
use of the device in question, one can begin sterility, compatibility, software
a search on the FDA database. The FDA validation, etc.
product code comprises three (03)
characters. This code can be used to find This will give you a general sense of the
information about GMP requirements, functioning of the device category and other
regulation descriptions, and product possible predicate devices. After completing
classification. this, visit the 510(k)-a database maintained
by the FDA.
Identifying the predicate device - One of the
first things companies must do when
preparing a 510(k) submission to the FDA is
to choose a precise predicate device. This is
critical because the 510(k) procedure
necessitates proving a device's substantial

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Step 2: Building a quality management Step 3: Device testing

system:
Testing the device to demonstrate its safety,
To support the 510(k) submission and effectiveness, and significant equivalency is
demonstrate the safety and integrity of the known as testing. The tests must run on the
device, one must have an efficient medical medical device and will depend on the
device quality management system with predicate device selected. The predicate
standardized, documented processes and serves as a benchmark and establishes the
procedures. It would be best to prioritize standards by which medical device testing
integrating FDA 21 CFR 820 and ISO 13485 will be accepted. Examples of typical testing
compliance before submitting the 510(k). are as follows:

Clear SOPs for each of the following areas • Electrical, thermal, and mechanical.
should be included in the QMS: • Components and makeup.
• Durability, wear, and fatigue.
Strategy for regulations and compliance • Sterilization and cleaning.
• The quality of biocompatibility.
• General requirements for performance
• Compatibility with electromagnetic fields.
and safety (GSPR) accountability for
management. • Feature performance in both typical and
unusual circumstances.
• Management of Resources.
• Control of risks. Four best practices for testing:
• Assessment of Performance.
• Realization of products. 1. Establish the test criteria based on the
• Specific Device Identity (UDI). product claims of the reference device.
• Following the sale, correspond with the
appropriate authorities. 2. Make ISO 14971 as standard.
• Field safety corrective action and incident
reporting. 3. Search for previous product recalls in the
category: Make inspiration from the flaws
• CAPA handling
• Tracking and Quantification. 4. Provide an electronic system to oversee
the design control work.
• Robust design, documentation, and
change control should also be a part of the As part of a larger initiative to move towards
QMS. digital submissions, the FDA no longer
requires a hard copy of the submission and
The device lifecycle should be
released its Electronic Submission Template
meticulously documented as the
in September 2022.
research, design, and development
phases progress. The easier it will be to
submit FDA 510(k) application, the more
documentation one completes in
advance.

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The FDA declared in October 2022 that the register for the CDRH Portal to electronically
CDRH Customer Collaboration Portal would complete and submit the eSTAR, a
accept 510(k) submissions via electronic templated dynamic PDF. The FDA is working
copy (eCopy) or electronic Submission to make 510(k)s quicker and simpler than
Template and Resource (eSTAR) due to its ever, and one aspect of that effort is this
early success. more regulated process.
However, starting October 1, 2023, the only
accepted format will be eSTAR. One must

Step 4: The wait - The FDA's official timeline is as follows:

•510 (k) applications received by the FDA.

Day 1

•The FDA sends an Acknowledgement Letter or a Hold Letter if there are issues with user fees and
Within 7 eCopy.
days

•The FDA conducts an Acceptance Review. FDA notifies the applicant if a 510(k) is accepted for
By day Substantive Review or put on RTA Hold.
15
•The FDA conducts a Substantive Review. The FDA communicates Substantive Interaction with the
By day applicant, indicating whether the FDA will proceed with an Interactive Review or ask for
60 Additional Information.

By day •The FDA sends the final MDUFA Decision on 510(k).

90

•The FDA sends a Missed MDUFA Decision Communication detailing any unresolved review issues
By day if an MDUFA Decision is not reached by day 100
100

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Step 5: FDA 510(k) Database Listing and DA Clearance

The FDA hopes to release its Medical Device decision letter as soon as a decision is made.
User Fee Amendments (MDUFA) ruling "Certified" refers to a 510(k) application that
within 90 FDA days. FDA days, which do not has received an S.E. decision letter. After
include days the submission was placed on that, it is included as an attachment in the
hold pending a request for more 510(k) database along with the 510(k)
information, are the number of calendar summary or 510(k) statement and the
days between the date the 510(k) was indications for using the medical device.
received and the date of an MDUFA decision. A successful 510(k) submission to the FDA
Findings of substantially equivalent (S.E.) or requires meticulous planning and execution,
not substantially equivalent (NSE) are supported by comprehensive
included in MDUFA decisions for 510(k) documentation and a deep comprehension
submissions. FDA emails the submitter a of the regulatory environment.

9. Documents required

Cover sheets
Performance
Documents

Digital/electrical Summary
Documents Documents

Safety Statement
Documents Documnets

S.E. Documents

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I. Cover sheets
• The FDA 3601 form (Medical Device User Fee Cover Sheet)
• The FDA 3514 form (CDRH Premarket Review Submission Cover Sheet).
• The user fee cover sheet is the payment receipt for starting the 510(k) procedure.
II. Summary documents
• Cover letter.
• Statement of indications for use
• 510(k) summary OR statement
510(k) submission is summarized in the cover letter.
For the final summary document, choose EITHER:
• Summary: A combination of information that the S.E. claim is based on
• Statement: Certification that you'll provide safety/effectiveness information to any
requester within 30 days.
III. Statement documents
The 510(k) 'statement' documents are:
• Truthful & accurate statement
• Class III summary
• Financial certification/disclosure statement
• Declaration of conformity & summary reports
Depending on the specifics of the submission, not every one of these documents may apply to
everyone.
IV. S.E. documents
The S.E. documents are for proving the device's substantial equivalence to its predicate.
It is done with three separate documents:
• Executive summary - An executive summary is a more thorough version of the 510(k)
summary with testing details.
• Device description - key technical information: Design History File, Design Outputs,
Drawings, Specs, Dimensions, etc.
• Substantial equivalence comparison - Side-by-side mapping of the device and its predicate,
including both devices' use, technology, and performance.
V. Safety documents
The following safety documents are included in the FDA 510(k) submission:
• Proposed labeling
• Sterilization and shelf life
• Biocompatibility
VI. Digital/electrical documents
There are two documents to consider here:
• Software
• Electromagnetic compatibility/ electrical safety.
VII. Performance documents
These are arranged in 3 sections:

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• Bench
• Animal
• Clinical
The first is mandatory; the other two may not apply to the operation.
All completed tests should have protocol descriptions, summaries, methodologies, and precise
results.

10. Mistakes to avoid while preparing for 510

(k)
Inaccurate
document
versions or
templates
Submission documents must
Selecting an
be more organized (loose
inappropriate
sectioning and numbering,
predicate
lack of a TOC, etc.).

Information that is
Inexperienced
inconsistent in places
risk/quality
where the submission
management.
repeats itself.

Ignoring to apply Ignore sections that

for minor business don't apply rather
status, wasting than explain why they
money. don't.

Inadequate test data

(summaries devoid of
protocols or reports)

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11. Conclusion
Navigating the FDA 510(k) submission navigate the submission process effectively,
process is essential for medical device bringing innovative and safe medical
manufacturers seeking clearance to market technologies to patients in need.
their products in the United States. This
guidance document has provided a
comprehensive overview of the 510(k)
pathway, covering key concepts. By
understanding the requirements and
intricacies outlined in this document,
manufacturers can better prepare for the
submission process, ensuring compliance
with FDA regulations and maximizing their
chances of successful clearance. The FDA
510(k) submission process represents a
critical step in bringing medical devices to
market, and adherence to regulatory
guidelines is paramount. By following the
guidance outlined in this document and
avoiding common errors, manufacturers can

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