Hi friends!!!
In our previous blogs, we have discussed about the following topics.
EU MDR Timeline, Annex, Chapter
EU MDR Post Market Surveillance
EU MDR Technical Documentation - Part 1
EU MDR Technical Documentation - Part 2
EU MDR General Safety and Performance Requirement
EU MDR Information on the Label
EU MDR Post Market Clinical Follow Up
EU MDR Unique Device Identification - Part 1
EU MDR Unique Device Identification - Part 2
EU MDR Chapter & Articles - Part 1
EU MDR Chapter & Articles - Part 2
EU MDR Procedure for Custom-Made Devices
EU MDR Certificates Issued by Notified Body
In today's blog, we will explore about 510(k) submission, its requirements, its importance of demonstrating substantial equivalence & how it impacts the medical device industry. Whether you're a startup or established manufacturer, understanding the 510(k) is vital for ensuring regulatory compliance and bringing your product to the market
It is also important for Medical Device QA/RA Professionals to know in detail about 510(k).
Let's get into the topic.
Premarket Notification 510(k)
Every domestic manufacturer,
specification developers, foreign manufacturers/exporters or U.S.
representatives of foreign manufacturers/exporters trying to market their
device in US shall submit 510(k). This will also be applicable for repackers or
relabelers who make labeling changes or whose operations significantly affect
the device. Therefore, it is very important for above mentioned stakeholders to
know in detail about 510(k) submission.
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What is Premarket Notification 510 (k)?
A
510(k) is a premarket submission made to FDA which requires you to demonstrate
that your medical device is substantially equal to the another legally US
marketed device. Substantial equivalence shall be demonstrated by proving that
your medical device is as safe and effective as the predicate device.
The term “Predicate” is used to
represent the medical device(s) legally marketed in US, to which equivalence is
drawn during the 510(k) submission.
The
question of your medical device’s substantial equivalence shall be based on the
following criteria:
The
first criteria to claim substantial equivalency to the predicate medical device
is that your device has same intended use as compared to the predicate medical
device and it has the same technological characteristics as compared to the
predicate medical device.
The
second criteria to claim substantial equivalency to the predicate medical device
is that your device has same intended use as compared to the predicate medical
device and even if your device has a different technological characteristic, it
shall not raise different questions related to the safety and effectiveness and
the information submitted to FDA shall demonstrate that your device is as safe
and effective as the legally marketed predicate medical device.
Product Codes:
The
Product codes are Three letter codes used by FDA to identify and track similar
medical devices
The
Product codes are used by 510(k) submitters to search for a predicate device(s)
to prove substantial equivalence. The Product codes can be found on most of the
510(k) clearance letters.
Types of 510(k) Submission:
Traditional 510(k)
The
Traditional 510(k) relies on demonstrating substantial equivalence. The
Traditional 510(k) can be used under any circumstances.
Abbreviated 510(k)
The
Abbreviated 510(k) relies on the use of recognized standards, special controls
and guidance documents. Under certain conditions, the submitter or sponsor
shall not need to submit the test data.
Special 510(k)
The
Special 510(k) shall be submitted in case of modifications to manufacturers own
legally marketed device. Data is not evaluated by FDA.
The
following are the questions that needs to be answered to attain eligibility for
Special 510(k) Submission:
Is
there any change to the manufacturer’s own legally marketed medical device?
Are
performance data needed to evaluate the change?
Are
there any methods which are well-established to evaluate the change?
Can
the medical devices data be reviewed in a summary or risk analysis format?
If
answers to all the above questions falls under Yes category, then your
modifications to the device shall be reviewed as Special 510(k).
Contents of 510(k) Submission:
The
following are the important information that needs to be submitted during
510(k), but are not limited to:
Indications
for use.
510(k)
Summary.
Declaration
of conformity & guidance documents.
Device
Description.
Substantial
Equivalence Discussion.
Proposed
Labelling.
Performance
Testing – Bench.
Performance
Testing – Animal.
Performance
Testing – Clinical.
Now I hope you have acquired some basic knowledge about the requirements of 510(k). We will meet again with another valuable topic related to MedTech Quality & Regulatory, Biomedical Engineering, Medical Device, Healthcare.
NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.
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