Paladin Medical’s expertise and commitment to high standards have resulted in countless successful product submissions, as well as robust compliance training for our clients. We welcome the opportunity to help make your medical product a success. Let’s get started.
Initial Regulatory Assessment: +
- We begin with a regulatory assessment for your project. Send us your confidential disclosure agreement (CDA) or we can provide you with a template.
- Give us a basic device description and a comparison of your product with alternative devices or technologies. Your existing presentation materials are often sufficient.
- We write a brief regulatory assessment to ensure we understand the nature of your device, how FDA would regulate it, and what we anticipate for the regulatory submission. We also offer regulatory assessment for submissions to countries other than the USA.
- Your new product could be Class I and exempt from 510(k); or, even exempt from Quality Systems except for documentation.
- Your new product may not be regulated as a medical device at all.
- Combination products can require more than one regulatory submission with more than one jurisdiction at FDA.
- If our regulatory services are right for the job, we provide our template consulting agreement with terms and fees for your review.
- We use the assessment to lay out a timeline and work estimate for your project.
- FDA’s deNOVO pathway for new devices without a predicate can be a benefit or a death-trap for a new product. Avoiding a PMA track can be critical, but if deNOVO is an option because of inadequate strategic planning, it could make the difference between success and failure for your new company. Don’t get caught off guard. We get out in front of the review for substantial equivalence and spell out your options.
New 510(k) Device Submission: +
- It is critical to plan your regulatory submission early. The updated Refuse to Accept checklist means early planning for content ensures a fast first phase review.
- FDA is more strictly interpreting old regulations and has high expectations for protocols and test reports, not just summary statements of work completed.
- Pre-clinical studies, such as animal trials and biocompatibility can have long lead times and significant costs. You need to know early what is needed.
- Expect that segments of recognized standards and FDA guidance documents will now be treated as “tic boxes” you must address in your submission.
- With the diverse experience Paladin Medical, Inc. brings to your team, your new submission will be timely and complete.
Investigational Device Exemption: +
- Clinical trials of an unapproved new medical device can be either Non-significant Risk (NSR) or Significant Risk and this determination is made not only on the type of device but also on the type of study you plan. We can help you understand the issues associated with your protocol design.
- Clinical trials in support of new medical device applications have different objectives than do academic research trials. Planning your study to meet your objectives is critical. We support all aspects of clinical trial management
Submission Support: +
- Now, more than ever before, you need a Champion for your submission. Some FDA challenges are based in 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 to your submission being found Substantially Equivalent or an IDE approval.
Secure Communications: +
- Paladin Medical clients are provided a secure online SharePoint site. We create a confidential and secure page for each client and provide personalized login information to only designated client contacts. Our Portal eliminates the need to send files back and forth via email for editing and also serves as an online backup of the crucial work in progress. Best of all you see your submission taking shape! Clients may login to their own secure Paladin Medical Client Portal here.
International Submissions: +
- International submissions take team work. We guide you in the preparation of your Technical File and prep you for any inspections, such as by your Notified Body. If you require a Design Dossier or Clinical Evaluation report, we can organize and prepare the contents. We work with your Notified Body to ensure that the contents meet your special requirements.
- Class I self-declaration requires preparation of the Technical File and labeling for presentation to the competent authority. We can author these documents and prepare your submission while on-site and work with your Foreign Representative to prepare what you need.