Fisher Scientific recently changed their shipping policy with respect to their defined medical devices and provided the following document with answers to frequently asked questions. If after reading this, you have further questions, please contact Greg Mosley in Purchasing Services or your Fisher Scientific sales representative.
Q: Why did Fisher update the policy?
A: Based on Fisher Scientific’s internal audits and reviews, they identified this policy update to further assure the quality of their products and the safety of their customers. These internal audits and reviews are conducted as a routine part of their Quality Management System in accordance with the Quality System Regulation (21 CFR 820). This policy update will further ensure that no adulterated medical device products are ever inadvertently returned into active inventory.
Q: Was this policy update brought about by any specific incident or event?
A: No. The recent update to their “no hassles” return policy did not result from any specific incident or event. They are unaware of any instances of adulterated products being returned back into their active inventory. They have, however, proactively taken this step to update their policy and further assure the quality of their products and the safety of their customers.
Q: Some customers were previously told that this was “due to a recent change in regulation.” Is that correct?”
A: No. The policy change was not brought about as a result of any specific change in regulation. Fisher Scientific routinely conducts internal audits and reviews as part of its Quality Management System in order to continuously improve its quality and in accordance with the Quality System Regulation (21 CFR 820). Based on their own internal audits and reviews, they identified this policy update to further assure the quality of their products and the safety of their customers. There was a “daily tip” communication that was issued by Customer Service that inaccurately attributed the policy update to a recent change in regulation. As a result, some customers were provided with inaccurate information. That inaccurate “daily tip” has since been corrected. Fisher Scientific apologizes for any confusion that this may have caused.
Q: What are their suppliers’ policies on the return of medical devices?
A: Their suppliers’ policies vary based on the supplier and the product. As a distributor, their decision to change their policy was independent of their suppliers’ policies.
Q: Is this policy change applicable to all of Thermo Fisher Scientific or just applicable to their channel business (Fisher Scientific/Fisher HealthCare and Fisher Science Education)?
A: The policy change is applicable only to their channel business and does not apply to all of Thermo Fisher Scientific. Their individual manufacturers, including their Thermo Fisher Scientific manufacturers, each have their own returns policies applicable to their specific products.
Q: What is a medical device?
A: A product is a medical device if the manufacturer registers it with the FDA. Many simple products that they do not normally think of as medical devices may be medical devices, including specimen cups, specimen slides, exam gloves, etc. You can have the same product be both a medical device and a non-medical device. For example, a manufacturer could sell the same glove under two catalog numbers and label one a “glove” and the other one an “exam glove”. Even though it is exactly the same product, the exam glove is a medical device, and the “glove” is not a medical device. The “exam glove” would be registered with the FDA, and the “glove” would not. If you are interested in the FDA’s classification of an exam glove, please see the following link: FDA Classifications.
Q: Does Fisher Scientific use the same definition of a medical device as the DFA uses when they classify their products as medical devices?
A: Yes. They use the same definition as the FDA. They have a written procedure that they follow to determine whether a product is a medical device. This includes a review of the product labeling or inserts, a review of the FDA database, and, if necessary, a consultation with the manufacturer.
Q: Has Fisher Scientific posted the changes to their website?
A: Yes. The following link takes you to the updated ‘Returns and Refund Policy’. The exclusion of medical devices is referenced in the last line of the paragraph entitled ‘Product Returns’. Fisher Refund Policy