Down Classifying a Medical Device from Class II to Class I

DCONN1

Starting to get Involved
#1
I have a question about what is perhaps a unique situation involving shifting classification of a device from Class II to Class I. My apologies, as this may be very difficult to explain without giving specifics;

A company owns a device which was cleared via a 510(k) submission. It was determined to be a Class II device based upon its indications for use, which encompassed a "general" use as well as an additional "specialized" use. Many years subsequent to clearance, the company decides that it would like to market the product with only the general use indications and drop the specialized use indication. This decision is made not based upon risk management concerns; the company makes this decision based upon the fact that this product is being used on the market exclusively for the general use indications, with the market for the product being used for its specialized indications being negligible to non-existent.

By marketing the product without its specialized indications, the device would be classified as Class I; it is only the inclusion of the specialized indication which causes it to be classified as Class II. As a benefit, by marketing the device without its specialized indication and thus re-classifying as Class I, the company can potentially greatly reduce the regulatory burden in countries around the world which use an FDA-equivalency registration pathway.

My questions are:
- Is this down-classification allowed to be done under the regulations? Is there any formal procedure involved other than internal documentation and listing the product on FURLS as a Class I device?
- I would assume that the company would need to recall the product on the market with labeling which includes the specialized indications for use. Would there be any other potential significant downsides to doing this?
 
Elsmar Forum Sponsor

JeantheBigone

Quite Involved in Discussions
#2
A down-classification is certainly possible, the question is what effort is required.

Any change in indications for use or labeling triggers the need for a modification 510(k). Especially a down classification, since the controls are less restrictive.

The only way I can see not needing a 510(k) is if the downclassified device is not only Class I, but Class I exempt AND there is nothing about the device or its intended use which trips the limitations of exemption.

I would avoid the use of the term "recall" and see if you can retrieve the product under a "market withdrawal."
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Alternatively, look at the downclassified device as a new device. Clear the new device based on its new ProCode's requirements (I would conspicuously highlight in the labelling that the "special" indications are not covered, to remove doubt). The old device can be either collected or left in the market provided that you maintain related obligations until the last unit issued with the old indications expires (there might be related record keeping requirements that go years beyond discontinuation, though).
 

shimonv

Trusted Information Resource
#5
What will serve as the predicate for the Class I device?
Hi,
You don't need a predicate for a class I device; what you do need is a regulation / product code that describes perfectly your device. If you have a product code you can do a search for class I device with the same code and thus make a better argument or increase your own confidence.

Shimon
 
J

Julie O

#6
Hi,
You don't need a predicate for a class I device
Why the qualifier "for a class I device"? Is there somewhere in the regulations where it says that procodes are used differently for Class I devices than for II and/or III?
 
J

Julie O

#7
Hi,
You don't need a predicate for a class I device; what you do need is a regulation / product code that describes perfectly your device. If you have a product code you can do a search for class I device with the same code and thus make a better argument or increase your own confidence.
Shimon
You say you don't need a predicate, but then you seem to go on to describe a process for finding a predicate?

If the procode is really appropriate to your device and if you can find a class I device with the same code, then that device will serve as your predicate. You must then demonstrate that your device is substantially equivalent to the predicate. This is true even if your device is 510(k) exempt.

(A device that is 510(k) exempt is exempt from the requirement to submit a 510(k) notification to FDA, but not from the need to show SE; otherwise, you don't know if the device you want to use as a predicate is actually suitable as a predicate, which means you don't know if your device really falls under the same classification regulation as the device you want to use as a predicate, which means you don't really know the classification of your device.)

If you can't find a predicate for your device (whether by using a procode or some other method) then, as far as I know, it is a novel device and you must submit a De novo petition to ask FDA classify it. FDA will then determine the classification of your novel device, assign it a new procode, and issue a new classification regulation that describes it.
 

shimonv

Trusted Information Resource
#8
Hi Julie,
To the best of knowledge and familiarity with FDA guidance documents, predicate devices and substantial equivalence are terms exclusive to class II devices; they are not applicable to class I or class III devices.

As for product codes - each is associated with one device class.
When it comes to class one devices (e.g. electric toothbrush or liquid measuring cup) - their design if fairly simple and intended use is very specific. It is my understanding that if you meet the exact definition of one of the class I regulation (e.g. 872.6865 for electric toothbrush) then your device is class I by self declaration.
Of course, you could do a search on similar class I devices in the market and even do a thorough comparison ('substantial equivalence') but its only comparing your self-declaration to someone else's self-declarion. It has limited value.

Hope it is helpful. Let's see what the rest of the forum members has to say.

Shimon
 

Marcelo

Inactive Registered Visitor
#9
To the best of knowledge and familiarity with FDA guidance documents, predicate devices and substantial equivalence are terms exclusive to class II devices; they are not applicable to class I or class III devices.
There are some Class I devices which requires 510K, in this case they would require a predicate device to show SE.

The predicate (and SE) is related to the pre-market notification. Devices exempt from 510K are not required to show SE.
 

Marcelo

Inactive Registered Visitor
#10
- I would assume that the company would need to recall the product on the market with labeling which includes the specialized indications for use. Would there be any other potential significant downsides to doing this?
Why would you need a recall of device which were marketed in compliance with the regulations they should comply?
 
Thread starter Similar threads Forum Replies Date
B Certificate Suspension? Shut down due to Covid-19 IATF 16949 - Automotive Quality Systems Standard 14
B FAR/Prime Contractor Flow-down Tool - AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Q AS9120B flow down to external providers: Records Retention AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
T Customer audit demands - that I state in my QM who can shut down production AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
Crimpshrine13 PPAPs (How far down the tiers are we supposed to get PPAPs)? APQP and PPAP 19
D Doing both a top-down and a bottom-up risk assessment - How to combine ISO 14971 - Medical Device Risk Management 6
qualprod Write down same nonconformity in several processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
CCaantley Stepping Down from my quality manager position soon After Work and Weekend Discussion Topics 18
M NIST is one of the government services shut down General Measurement Device and Calibration Topics 2
R Cascading (Flow Down) Customer Specific Requirements IATF 16949 - Automotive Quality Systems Standard 2
B AS9102 Supplier Flow Down Method AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
A MedAccred being flowed down to Suppliers (2018) MedAccred Industry Group Program 0
J ITAR flow down to Processors (Outsourced Processes) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
L Machines can't go down at all...... Management wants statement Manufacturing and Related Processes 31
M What is the lightest material to make a Strong and Light Ratchet Tie Down Strap Manufacturing and Related Processes 1
Q Where to place a Down Stream Gage Inspection on an FMEA FMEA and Control Plans 5
M Document Control Management - External documents flowed down from customers Document Control Systems, Procedures, Forms and Templates 2
T ITAR/EAR relationship and Flow Down to Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
C Whittling down procedures and processes Document Control Systems, Procedures, Forms and Templates 15
L Excel 2013 file issue - Information in the drop down menu disappears Excel .xls Spreadsheet Templates and Tools 2
A FTA-Top/Down approach to Risk Analysis ISO 14971 - Medical Device Risk Management 2
M How to Hide Drop Down Combo Boxes (Excel) Excel .xls Spreadsheet Templates and Tools 5
Wes Bucey Hospital Turns Down Malcolm Baldrige National Quality Award World News 0
N Faux Document Control System - Tear it down or transition? Document Control Systems, Procedures, Forms and Templates 13
V Quality Roadmap from Voice of the Customer way down to Supplier Quality Manager and Management Related Issues 4
T Uncertainty (Top Down Method)! Auditor argues that this is not enough Measurement Uncertainty (MU) 14
D FDA Reclassification of Medical Devices - Class III device down to Class II 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Can the Auditor close down the Corrective Actions? Internal Auditing 12
Z AS9100 Clause 7.4.2.d Revision Letter Flow Down to Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
Marc Business These Days - Maker's Mark waters down bourbon to meet demand Coffee Break and Water Cooler Discussions 11
G Defining Post Mold Cure Ramp-Down Temperature Manufacturing and Related Processes 2
R FAR 145.205 - Maintenance Program Flow Down Requirements Federal Aviation Administration (FAA) Standards and Requirements 3
P General Manager jumps down to directly contact my staff Quality Manager and Management Related Issues 7
B Requirement for ISO 9001 Flow Down to Supply Chain? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C Flowing Requirement(s) down to Subcontractors Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
J 7.4.2g ?flow down to the supply chain the applicable requirements including customer AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Richard Regalado Megaupload Shut Down After Work and Weekend Discussion Topics 0
B Rounding Numerical Values Up or Down with respect to the number of Significant Digits Measurement Uncertainty (MU) 9
F AS9100 8.5.2 g - Flowing Down Corrective Action Requirements to a Supplier AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T Drop Down ("Standard") Categories for Corrective Actions & Root Cause Nonconformance and Corrective Action 4
P Blackberry Server Down - October 2011 Coffee Break and Water Cooler Discussions 4
N VDA 6.x - Requirements Pass Down to Suppliers ....Obliged?? VDA Standards - Germany's Automotive Standards 5
G Scaling down the certification scope - good idea? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
N Is there a standard length of time to track down non-responding customers w recalls? Misc. Quality Assurance and Business Systems Related Topics 2
G Packaging Re-Validation - Sealer machine broke down or was changed to a new one Other ISO and International Standards and European Regulations 11
A How to create Drop Down Box in Excel 2007 Excel .xls Spreadsheet Templates and Tools 2
somashekar Driving CSR (Corporate Social Responsibility) Performance down the Supply Chain Supplier Quality Assurance and other Supplier Issues 8
N Advice on turning down a job offer that I had already accepted Career and Occupation Discussions 18
D How do I "Drop Down List" that is a "pick all that apply" in Excel Excel .xls Spreadsheet Templates and Tools 6
SteelMaiden Down on the Bayou Funny Stuff - Jokes and Humour 5

Similar threads

Top Bottom