Classification of a Medical Device in FDA

[celia4237]

Dear all:

We are planning to manfacture a new device, which is called loupe, it has a maginifying glass on one end, which can magnify the small things, for example, the cut in the foot. It also has battery-powered LED near the magnifying glass to light up.

How to classify this medical device? I have searched the database of classifiaction, and found that there is no equal device. In 878.4800, it is loupe, diagnostic/surgery, but it is non-powered.

It seems that I can't decide which calssification does it belong to in the database, but i think this kind of medical device is low-risk, many similar medical device all belong to calss 1, and this loupe should also belong to class 1.

What can i do under this situation?

Thanks a lot~

 

[Chris Ford]

Re: Questions about the classification of medical device in FDA

Sec. 878.4800 is a manual surgical instrument for general use - it's a catch-all. Your device seems to be: Sec. 886.5120 Low-power binocular loupe. It's impossible to be 100% on this unless I know the actual indications. The indications for your device can't go beyond the indications stated in the regulation.

Here's a guidance document: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073944.htm

 

[Ajit Basrur]

Re: Questions about the classification of medical device in FDA

Dear all:

We are planning to manfacture a new device, which is called loupe, it has a maginifying glass on one end, which can magnify the small things, for example, the cut in the foot. It also has battery-powered LED near the magnifying glass to light up.

How to classify this medical device? I have searched the database of classifiaction, and found that there is no equal device. In 878.4800, it is loupe, diagnostic/surgery, but it is non-powered.

It seems that I can't decide which calssification does it belong to in the database, but i think this kind of medical device is low-risk, many similar medical device all belong to calss 1, and this loupe should also belong to class 1.

What can i do under this situation?

Thanks a lot~

The name of the device is loupe, binocular, low power and is a Class I device under Regulation Number 886.5120

However, this one is used for Ophthalmic Device

The description of the device that you mentioned aptly fits this as well

Note: I missed Chris response earlier !!!

 

[celia4237]

Re: Questions about the classification of medical device in FDA

Sec. 886.5120 Low-power binocular loupe. (a)Identification. A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

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The above information is the description of the Low-power binocular loupe. But our device is pencil-like with only one maginifying glass. What does it belongs to?

 

[celia4237]

Re: Questions about the classification of medical device in FDA

Moreover, it intends to be used at home, not in the ophthalmology.

How to classify this medical device?

 

[Chris Ford]

Re: Questions about the classification of medical device in FDA

Moreover, it intends to be used at home, not in the ophthalmology.

How to classify this medical device?

That's the point I made earlier. You need to consider your indications and intended use when determining where to classify your device. The indications need to fit within the regulation description. Take a look at this link for assistance:

http://www.fda.gov/MedicalDevices/D...nce/Overview/ClassifyYourDevice/ucm051530.htm

 

[celia4237]

Re: Questions about the classification of medical device in FDA

Thanks Chris.

I know what you mean, but i think the correct way of thinking is: Deciding the indication at intended use at first; searching the classification database and decide which classification does it belong to; If no corresponding classification, then there should be some mechnism for the manufacturers to decide how to classify it and marketed.

I believe that there must be many medical devices, especially the new device goes beyond the FDA's database, and they are low-risk and should be exempted from 510(k). Do you think so?

BTW, the medical device has only one magnifying glass, but 886.5120 consists of two eyepieces. So maybe there is no corresponding clasisification for my device.

 

[celia4237]

Re: Questions about the classification of medical device in FDA

Dear all:

I have written an E-mail to DSMCA and was told that i should contact with the ODE department for a classification of me device because there is no equal device in their database.

Does anyone have the same experience as me?

 

[gar4guv]

Re: Questions about the classification of medical device in FDA

how about this classification:

Sec. 886.5915 Optical vision aid.
(a)Identification. An optical vision aid is a device that consists of a magnifying lens with an accompanying AC-powered or battery-powered light source intended for use by a patient who has impaired vision to increase the apparent size of object detail.

(b)Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

 

[celia4237]

Re: Questions about the classification of medical device in FDA

how about this classification:

Sec. 886.5915 Optical vision aid.
(a)Identification. An optical vision aid is a device that consists of a magnifying lens with an accompanying AC-powered or battery-powered light source intended for use by a patient who has impaired vision to increase the apparent size of object detail.

(b)Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

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Thanks, i think this classification fits my device.