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

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 ?

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.