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A STEP-BY-STEP
GUIDE TO
DETERMINE HOW
YOUR MEDICAL
DEVICE WILL
BE CLASSIFIED
JO N S P EER ,
FO U N DE R & V P OF QA /RA GREEN L IG HT.G URU
A STEP-BY-STEP GUIDE TO DETERMINE HOW YOUR MEDICAL DEVICE WILL BE CLASSIFIED PAGE 1
A STEP-BY-STEP
GUIDE TO DETERMINE
HOW YOUR MEDICAL
DEVICE WILL BE
CLASSIFIED
TABLE OF CONTE N TS
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A STEP-BY-STEP GUIDE TO DETERMINE HOW YOUR MEDICAL DEVICE WILL BE CLASSIFIED PAGE 2
A STEP-BY-STEP GUIDE TO
DETERMINE HOW YOUR MEDICAL
DEVICE WILL BE CLASSIFIED
classification.
In this guide, I will provide you with a step-by-step approach for determining
how your medical device will be classified by U.S. FDA, European Commission,
agencies have defined a bunch of rules and regulations (or “laws”) regarding
medical devices.
The rules that apply to your medical device depend on how your product
The classifications are, for the most part or as a general rule, related
To some extent, you are correct. And fortunately, too, there are quite
When you start to explore how your medical device product idea will be
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A STEP-BY-STEP GUIDE TO DETERMINE HOW YOUR MEDICAL DEVICE WILL BE CLASSIFIED PAGE 4
Knowing how your medical device is classified matters for the following reasons:
Because of this, I’m going to provide you with a little bit of guidance to better
Note, the information I’m about to provide is intended to help educate you on
medical device regulatory classification and what is required for your medical device.
yet should give you some basic guidance and direction on identifying how
The mission of CDRH is to protect and promote public health. In other words,
In the U.S., medical devices are either Class I, Class II, or Class III. The FDA CDRH
Class I are generally deemed low risk and Class III highest risk. The types
Intended Use is the general purpose of the medical device or its function
Indications for Use describe the disease or condition the medical device
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A STEP-BY-STEP GUIDE TO DETERMINE HOW YOUR MEDICAL DEVICE WILL BE CLASSIFIED PAGE 6
Keep this in mind. The intended use and indications for use of your medical
device express the reason why you had this idea for a new medical device.
Once you define intended use and indications for use, now you need to find the
for your product via FDA takes a little bit of time and perseverance.
Without boring you with too many details, FDA has established several general
When you find the possible categories and click on the FDA regulation number,
the list of possibilities suddenly seems endless. Here is a partial view of the
When you find a regulation that appears to be a possible fit, you can click
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A STEP-BY-STEP GUIDE TO DETERMINE HOW YOUR MEDICAL DEVICE WILL BE CLASSIFIED PAGE 8
The details provided give me some idea if my intended use and indications
which means I will need to submit a 510(k) to FDA prior to getting market
clearance.
Finding the applicable regulation for you medical device and classification
is the first part. Now you need to find the applicable product codes.
Here’s how:
number you found. If you find more than one possibility, then you will need
When you click “search”, you will get a list of possible product codes.
You can then review each individual code to determine the best option
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A STEP-BY-STEP GUIDE TO DETERMINE HOW YOUR MEDICAL DEVICE WILL BE CLASSIFIED PAGE 10
Knowing the applicable regulation and product code (as described above)
Once you have this information, you will now be able to determine the “path”
• Class III (high risk): general controls and Premarket Approval (PMA)
If you find your product is “exempt,” then only general controls apply and
no formal FDA submission is required. You do, however, need to register your
If you find your product requires special controls, this means you will have
to market. And then need to register your establishment and list the product.
If you find your product requires premarket approval, this means you will have
to follow the FDA PMA process to receive approval before going to market.
A STEP-BY-STEP GUIDE TO DETERMINE HOW YOUR MEDICAL DEVICE WILL BE CLASSIFIED PAGE 11
a CE mark.
To figure out what is required to CE mark your medical device, you first must
• Non-Invasive
• Invasive
• Active
For each of the broad categories, there are certain rules which apply. These
categories coupled with the duration for use make determining classification
fairly straightforward.
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A STEP-BY-STEP GUIDE TO DETERMINE HOW YOUR MEDICAL DEVICE WILL BE CLASSIFIED PAGE 12
Let’s consider the percutaneous catheter example used earlier when discussing
FDA classification.
search down to rules 5, 6, 7, and 8. I narrow the rules down further because
• Class I
• Class IIa
A STEP-BY-STEP GUIDE TO DETERMINE HOW YOUR MEDICAL DEVICE WILL BE CLASSIFIED PAGE 13
• Class IIb
• Class III
All EU medical device classes require working with a Notified Body except for Class I.
You will also need to work with an Authorized Representative to take care
Like EU, Canada has a pretty easy to follow guidance document and it’s very
similar to Europe..
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A STEP-BY-STEP GUIDE TO DETERMINE HOW YOUR MEDICAL DEVICE WILL BE CLASSIFIED PAGE 14
Like EU, you will need to determine if your medical device is:
• Non-Invasive
• Invasive
• Active
For each of the broad categories, there are certain rules which apply.
These categories coupled with the duration for use make determining
and U.S.
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A STEP-BY-STEP GUIDE TO DETERMINE HOW YOUR MEDICAL DEVICE WILL BE CLASSIFIED PAGE 16
• Class I
• Class II
• Class III
• Class IV
Prior to going to market in Canada, you must apply for a medical device license.
A license is not required for Class I medical devices. This Health Canada
guidance walks you through the process. Class III and Class IV medical devices
You will also need to obtain ISO 13485 certification with CMDCAS (Canadian
A STEP-BY-STEP
GUIDE TO DETERMINE
HOW YOUR MEDICAL
DEVICE WILL BE
CLASSIFIED
317-960-4220
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