Prepare applications meeting up-to-date requirements including global strategies
In order to plan a premarket submission, it is necessary to understand the various options for clearance or approval.
- As a part of our LAUNCH planning we confirm the type and scope of your first submission and confirm that you need one! Not all medical devices need premarket clearance of approval directly by FDA. Read more in Launch
- We help your team integrate the requirements of a submission into your Design Control and Review Quality Systems Regulations. Read more in Design Control
- We will also help you determine if you might benefit from a Pre-Submission to FDA. Read more about Pre-Submission in SPECILATY SERVICES
- FDA publishes hundreds of guidance documents and recognizes a multitude of international and national standards. We can help you make sense of it all for your new product. We can lead you through the maze.
International Submissions: Read more about Global Regulatory Strategies in SPECIALTY SERVICES
Determination of Classification and Risk:
The first fundamental task to planning a likely regulatory pathway to market is the determination of device classification and risk. We start with helping you identify the proper classification and assessing the relative risk of your product to prior art. 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.
Substantial Equivalence is a technical comparative argument at the core of the 510(k) application. Most Class II devices are cleared to market through the 510(k) pathway, and some new Class II devices may not be substantially equivalent to their predecessor (known as a predicate.). For a US 510(k) we must assess the similarities and differences between your product and a prior product legally on the US market. There are various conditions by which your product may not qualify as “equivalent”. A few Class III devices may even clear through 510(k). A new device with new technology and new risks could require pre-market approval if FDA determines that safety mitigations are not adequately addressed by testing. Some may be candidates for “deNovo”. We help you figure this out!
Device risk classifications can differ between the US and jurisdictions outside the US. In most cases we recommend a US application first for a US based company because the overall regulatory structure in the US is typically easier for a start-up US based company to manage.
Pre-Submission Meeting with FDA
Pre-submission meetings with the FDA require careful preparation for a successful outcome. Pre-submissions can be disastrous without a regulatory strategy and clear objective for the meeting. The Pre-submission development effort can save time and money when done right. Paladin Medical® will:
- Help you decide if a meeting is warranted
- Prepare your pre-sub documentation with your team
- Submit the pre-sub in the proper format
- Make the arrangements with FDA
- Prepare you for the teleconference if you choose to conduct one
- Help you express your company’s professional position and sound technical judgment
- Prepare minutes and help you turn your findings into actions
FDA Regulatory Pathways and Submission Types
Some of the pathways to market you may not have heard much about.
- Special 510(K)
- Traditional 510(k)
- Abbreviated 510(k)
- PMA and PMA supplements
- De Novo
- Combination Product – Read more in SPECIALTY SERVICES
Investigational Device studies may be required to support any of these pathways. We provide services to assure they are conducted properly when needed. Read more in CLINICAL TRIALS
A submission may be needed when there is a change to a device that is already 510(k) cleared. We can help you assess the changes and prepare a submission if required. Read more about deciding when to submit in SPECIALTY SERVICES.
Submission Preparation, Filing and Support
Now, more than ever before, you need a Champion for your Successful submission. Our strategic planning and careful preparation can minimize delays and optimize your timetable. These services include:
- Task planning for submission deliverable documents based upon Refuse to Accept guidance
- Review of protocols and all testing plans and review of test reports as produced
- Assist in proofreading and editing of critical documentation such as labeling and DFU
- Assuring proper construction of statements of indication for use and intended use
- Draft preparations of the full submissions as deliverables become available
- Compilation of documents and double-checking content for completeness.
- Document production according to FDA electronic submission requirements
Some FDA challenges are based on communication differences or the special requirements of your new product that the FDA reviewer may not have previously encountered. Timely and well-crafted responses to deficiencies make the difference.