How can an Optional Accessory of a Medical Device be sold alone?

Y

yarina

#1
Hi all:

How can the accessory of a medical device be sold alone to the user except for through service?
Since the accessory is optional and can only work with the main system. Is a separate package for the accessory with proper notice OK? Or it have to be cleared by FDA?
:thanks:
 
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Stijloor

Staff member
Super Moderator
#2
Hi all:

How can the accessory of a medical device be sold alone to the user except for through service?
Since the accessory is optional and can only work with the main system. Is a separate package for the accessory with proper notice OK? Or it have to be cleared by FDA?
:thanks:
Any medical device experts who can help?

Thank you!!

Stijloor.
 
E

esalsan

#3
Hi, I have no experience with accesories, but the scope of 21 CFR 820 does not seem to make any exclusions to accessories:

The scope of 21 CFR 820:
"(a)Applicability. (1) Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use."

Where
"Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized." (definition l 820.3)

I do know in Europe, the Medical Device Derective applies as well to accessories:
Article 1."This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices"

Hope it helps.
 
W

wangyang

#4
The question is, if we get 510(k) cleared for the system(which include the main device and the accessory), and if the accessory labelled as "can only be used together with the main device), can we package and sell the accessory seperately?

I think it is permitted, because the difference is from a "system" package to a "main device" package and an "accessory" package, and it is a design modification which will not bring any S&E problem, right?
 
M

MIREGMGR

#5
Yes to Wangyang's questions. The accessory is treated as a regulated device, and labeled as intended only for use with the associated system/product.
 

amjadrana

Involved - Posts
#6
My question relates to the same issue but specific for CE marking. If one system has some accessories that are off the shelf products but are not medical devices as per definition; but have to be used with the system like straps, collars, how will we be able to Mark them. Can these be marked as CE if these are to be sold with the system or later on separately as well.
Also if there is a accessory made according to our design by another manufacturer, can we put our name and CE mark on the accessory.

I could not find an answer directly in the directives or guidances. Thanks for your help. I
 
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