Tarek Elneil I don't believe that this is a medical device but it is a pharmaceutical because the critical component is the drug and not the syringe. The syringe is just a delivery system. I worked with injectable nonconformance that is similar to the insulin pen and that was in a pharmaceutical company. Please let me know if this answered your question ?

Dan Golka I would list it under diabetic and syringes. List it on the Med tech Directory today.

Julie Omohundro Are you talking about some type of regulatory category?

Hello, Durable medical equipment, diabetic supply.

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Ole Overgaard Tarek Elneil in Europe medical devices that are a "single integral product
which is intended exclusively for use in the given combination and
which is not reusable" should be registered as a medicinal product (i.e. a pharmaceutical). However such a product will still have to comply with the Medical Device Directive Essential Requirements "as far as safety and performance-related device features are concerned.". Thus if the injector is reusable it is a medical device, if not, it is a medicinal product that should still comply with the Essential Requirements of the MDD.

In the USA this would be a drug-device combination product governed by 21 CFR part 4.

Does the pen have insulin pre-loaded or is it a delivery device? That would determine the category assuming you mean regulatory.

Giorgio Scita I think is a class IIa because normally have sterile needle and used with "farmaceutical" and go to inside the patient body

Bruce Ackman Chris - Class II http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM147095.pdf

Stacy Livingston According to which legislation? In Europe, this would a MDD IIb -http://obelismedical.net/wp-content/uploads/2014/12/MEDDEV-2.4-1-Rev.-9.pdf

I would say class IIa according to MDD: http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf

Daniel Davis Call the FDA on the phone! Simple as that

Stacy Livingston Mark Bertens Under Rule 6 at the bottom of the table you will note:

"- intended to administer medicines by means of a delivery system, if this is
done in a manner that is potentially hazardous7 taking account of the mode of
application, in which case they are Class IIb. " Insulin pens are specifically mentioned as a example :)

Stephen Allan Weitzman See Also related 510(k)s. They are numerous. Search under the CFR number.

If by category you mean risk classification, I can confirm that in Canada the pen itself would qualify as Class II. If sold pre-loaded with insulin it would qualify as a medical device/drug combination product that would be regulated as a drug

Robert Betz I believe it is an accessory to a drug as a drug delivery system. Regulatory concerns would be related to accurate dose delivery and device safety

Stephen Allan Weitzman Class II -- 21 CFR 880.5570 See iraionline.org (The Free FDA Information Repository)

sue dirkes Pharmaceutical.. It is a drug

In USA reusable insulin pens filed via 510 (k) route fall under class II. However, while the device classification and code do not apply to pre-filled insulin pens filed as drug device combination product via drug (505 b2) route.