Not saying the FDA is perfect nor that all FDA regulations should not be examined. Still, it is nice to see the FDA action in this case averting a potential disaster in the USA.
Please note that the “Kitemark” is distinct from the “CE Mark”, more correctly “CE Marking”. The Kitemark is the property of the British Standards Institution (BSI) and demonstrates an independent confirmation of the compliance a product with a British Standard. Moreover, the manufacturer must have a management system independently assessed to ISO 9001 and meet certain other criteria that may be appropriate. CE Marking is nothing more than a claim that a product, whose manufacture is subject to one or more of various laws (directives), meets the law. In the case of certain products (such as breast implants), this compliance must be assessed by a notified body. However, as the article hints, not all notified bodies are equally competent.
Not saying the FDA is perfect nor that all FDA regulations should not be examined. Still, it is nice to see the FDA action in this case averting a potential disaster in the USA.
Please note that the “Kitemark” is distinct from the “CE Mark”, more correctly “CE Marking”. The Kitemark is the property of the British Standards Institution (BSI) and demonstrates an independent confirmation of the compliance a product with a British Standard. Moreover, the manufacturer must have a management system independently assessed to ISO 9001 and meet certain other criteria that may be appropriate. CE Marking is nothing more than a claim that a product, whose manufacture is subject to one or more of various laws (directives), meets the law. In the case of certain products (such as breast implants), this compliance must be assessed by a notified body. However, as the article hints, not all notified bodies are equally competent.