Paladin Medical will assess submission requirements for your new medical product to optimize your regulatory strategy. FDA has exempted hundreds of medical devices which formerly required a 510(k), yet Class I devices may still require a submission if the new product falls outside the technological similarities of the predicate devices or FDA’s original regulation description. Some Class III devices may be cleared by 510(k), and some Class II devices can require a pre-market approval if FDA determines that the new technology introduces safety issues that have not been adequately addressed by testing.
FDA publishes hundreds of guidance documents on their website, and recognizes a multitude of international and national standards. We’ll help you make sense of it all for your new product.
We can lead you through:
- Special 510(K)
- Traditional 510(k)
- Abbreviated 510(k)
- De Novo
- Assessing changes to an existing device for Memo to File