Requirements and Product Exemptions +
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
Deciding when you need a Pre-Submission Meeting with FDA +
Pre-submission meetings with the FDA can ensure that new product development efforts result in a satisfactory submission. Meeting with the FDA requires careful preparation and being unprepared can be disastrous. They are time-consuming and involve preparation for a successful outcome.
Paladin Medical will:
- Help you decide if a meeting is warranted
- Prepare you and your team
- Make all the arrangements
- Contact the right people at FDA
- Organize and plan your contact with FDA to give the best regulatory position possible
- Develop your proposal using a proven format
- Set an agenda for your face-to-face or teleconference meeting with key FDA personnel
- Help you express your company’s professional position and sound technical judgment