FDA Related FAQ
As an authorised reseller of Dr. Pen products, we have been advised the manufacturer of the range is seeking a re-classification of their products by the FDA. There has been no change to the design and manufacture of the products.
If you would like to be notified when the Dr. Pen range is FDA registered, please sign up your email to register your interest below.
For more information, please see our Frequently Asked Questions below or contact our Customer Service team.We apologize for any inconvenience and thank you for your loyalty to our Dr. Pen range.
Frequently Asked Questions
Q: Why can't I find/buy anything on Dr. Pen website?
A: Unfortunately, as an authorised reseller of the Dr. Pen range, we have been advised to pause all sales of these products until the manufacturer advises us, they have obtained a re-classification of the range by the FDA. Once we are notified the FDA re-classification has been obtained, we will reinstate the range on our website for sale.
Q: Will Dr. Pen stop selling forever?
A: No. The manufacturer of the Dr. Pen range is currently seeking reclassification of the products with the FDA. We anticipate this re-classification, which will pave the way for us as an authorised re-seller to resume sales of the range, which should occur in early 2023.
Q: I need a cartridge replacement for my pen. What can I do?
A: Unfortunately, as an authorised reseller of the Dr. Pen range, we have been advised to pause all sales of these products including cartridges until the manufacturer advises us, they have obtained a re-classification of the range by the FDA. If you would like to discuss other options, please click here to live chat with one of our helpful customer service team members.
Q: Is this a global issue or does it just affect US residents?
A: The Dr. Pen range including replacement cartridges that we are authorised to resell remain approved for sale online in two other regions - in Australia (under the Therapeutic Goods Administration) and the United Kingdom. It is the FDA in the US that has advised the Dr. Pen manufacturer to apply for a new classification of the range.
Q: Is Dr Pen products still safe to use?
A: The Dr. Pen range has been approved for sale and use by regulatory agencies in major global jurisdictions - where we continue to sell these products. There has been no change to the design or manufacture of the Dr. Pen range that previously was approved for sale by the FDA in the US. The manufacturer has sought to have the Dr. Pen range re-classified by the FDA for sale and use, which has prompted our decision to temporarily pause selling the range on our US website only.
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