Submissions

Submissions

Not all new medical devices for the US Market require an application to FDA prior to marketing. Paladin Medical® will conduct a Regulatory Assessment to ascertain product classification and if your product may be exempt from submission. See LAUNCH YOUR MEDICAL DEVICE

If your efforts include international market entry, please read more in Read more about Global Strategies in STRATEGIC SERVICES

Pre-Submission Planning:
We will also help you determine if you might benefit from a Q-Submission to FDA. (Also known as Pre-sub). Read more in LAUNCH YOUR MEDICAL DEVICE

FDA Regulatory Pathways to Market and Submission Types
Paladin Medical® will help you sort through the many premarket application pathways.

• Special 510(K)
• Traditional 510(k)
• Abbreviated 510(k)
• PMA and PMA supplements
• HDE/HUD
• De Novo
• 513g-Request for Classification Determination (Read more below)
• Combination Product Read more about Combination Products in STRATEGIC 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 PRECLINICAL / CLINICAL

Eeeee-Submissions! Electronic submissions may save trees, but they do not reduce the need for attention to details. Weeee know how to make E-Submissions acceptable to FDA and therefore efficient for you!

513g? The 513g is a little practiced communication with FDA to help to define the Classification of a proposed new product. This pathway is more formal and technically more difficult than a “Q-sub” but has a much more significant impact on the progress of a product when its classification is as yet undetermined. Sometimes conducting a regulatory assessment can identify issues that only FDA can resolve. This pathway may be the only way to satisfactorily resolve whether a product is EXEMPT when there is question about either technology or intended use may cause the “exception to the exemption” to take effect. This can occur when a new technology may introduce a new risk for a Class 1 exempt or Class 2 exempt device. Paladin Medical® can recommend when this option is prudent, and guide your team in the preparation of the necessary documentation.

510(k) 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 “exempt” devices with a new intended use or technological difference, a 510(k) may still be necessary. A few Class III devices may even clear through 510(k). The maze of guidance documents and standards can prove daunting. Despite all the literature articles and training programs, a 510(k) is not a do-it-yourself adventure. You need the experienced experts at Paladin Medical, Inc. to blaze the path and be your champion. We can provide your team with a list of deliverables for the submission to make the preparation easier.

510(k) Deficiency Response: If your submission has deficiencies returned by the FDA Reviewer, we help to analyze the issue and make a timely response. Sometimes FDA challenges are based on communication differences or the unique requirements of your new product. We help forge timely and well-crafted responses to deficiencies and set up “SIR” meetings if necessary.

Deciding when to submit a 510(k) for changes to a device with and existing 510(k)

Whether the change to your 510(k) medical device is for safety and performance reasons, made in order to stay abreast of competitors or simply to maintain production when a supplier is no longer suitable or available, knowing when a new 510(k) is necessary is critical to compliance with FDA regulations. Quality systems require that a company document changes and review, evaluate and revalidate these changes when appropriate. So, at what point might a change to a device trigger the need to make a new 510(k) application? FDA has provided ample guidance. (And most international regulatory schemes stipulate when a new authorization may be necessary.

Paladin Medical® can help your company make the best determination on when a new submission is triggered and if it can be a Special 510(k). Making the determination is one task, but proper documentation of the justifications to not file is probably more important. Sometimes changes add up to create a need for re-submission, even when an individual modification did not. Your team may understand these requirements; but may simply want a third-party review of the determination and documentation. With our expertise and experience we can aid your team in making the best choices and documenting sound decisions.

International Submissions: Read more about Global Strategies in STRATEGIC SERVICES

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Pre-Submission Planning

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 Your Medical Device
• 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.
• 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 STRATEGIC SERVICES
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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.
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Substantial Equivalence

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.
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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

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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
• HDE/HUD
• De Novo
• Combination Product – Read more in STRATEGIC 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 STRATEGIC SERVICES.
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Submission Preparation, Filing and Support

Now, more than ever before, you need a Champion for your Successful submissions. 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.
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