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Private answer Dan Golka I would list it under diabetic and syringes. List it on the Med tech Directory today. Marked as spam | |
Private answer 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 ? Marked as spam | |
Private answer Julie Omohundro Are you talking about some type of regulatory category? Marked as spam | |
Private answer IMD Injectable Medical Devices will change the current methods. Long gone are the days of high-risk, invasive brain probing, when the brain was a mysterious arena we could barely touch without serious repercussions. While it’s still the most complicated organ, a research team from Harvard University has developed an electronic device that is so tiny and flexible it can be directly injected into the brain, where it can monitor brain activity and possibly even treated diseases like Parkinson’s or paralysis. http://www.medicaldaily.com/new-injectable-device-may-revolutionize-parkinsons-disease-treatment-brief-history-337338 Marked as spam | |
Private answer 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. Marked as spam | |
Private answer Giorgio Scita I think is a class IIa because normally have sterile needle and used with "farmaceutical" and go to inside the patient body Marked as spam | |
Private answer Bruce Ackman Chris - Class II http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM147095.pdf Marked as spam | |
Private answer 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 Marked as spam | |
Private answer 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 Marked as spam | |
Private answer 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 :) Marked as spam | |
Private answer Stephen Allan Weitzman See Also related 510(k)s. They are numerous. Search under the CFR number. Marked as spam | |
![]() Private answer 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 Marked as spam | |
Private answer Stephen Allan Weitzman Class II -- 21 CFR 880.5570 See iraionline.org (The Free FDA Information Repository) Marked as spam | |
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