Other FDA Interactions: De Novo, HDE

Gain market approval efficiently

The collective experience and knowledge at AlvaMed allows us to develop successful FDA submissions of all types and accelerate our clients’ progress to market launch. Whether you need support for a single product, platform technology, or multiple product lines, we’re here for you across all types of medical devices – from SaMD to implantable and large diagnostic equipment. 

AlvaMed subject matter experts will help you define the regulatory pathway to bring your product to market in the most efficient manner based on the claims being made. With considerable experience and knowledge of the De Novo pathways, AlvaMed provides expert support for your novel medical devices.

Applicants often find themselves having to submit a PMA supplement for review and approval by FDA as required before making any change affecting the safety or effectiveness of the device. Having a regulatory partner such as AlvaMed will provide confidence in your compliance efforts.

Managing Humanitarian Use Devices (HUDs) and the required application for exemption (HDE) is complex because of the need to gather sufficient clinical evidence to meet the FDA standard for determining safety and effectiveness.

FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.

With the output of the “project meeting” AlvaMed creates a formal proposal for the project that, when signed, will serve as our agreement. Most of our projects have a compliance component and in most cases, we are required to be an approved supplier. We have internal processes that are Part 11 compliant, so this process can be completed quickly. Should you be a larger company, we are happy to review and agree to a Master Services Agreement.

The trusted partners at AlvaMed use their wealth of regulatory prowess to lead clients toward successful device compliance and market clearance.

Our clients are happy to be references – we are happy to share their contact information when you meet with us.

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Other FDA Interactions: De Novo, HDE FAQ's

Data Requirements: Collecting, analyzing, and presenting this data in a manner that satisfies FDA requirements can be resource-intensive.

Timing and Delays: PMA supplements often involve a review process by the FDA, and the timing of the review can be unpredictable. Delays in the approval process can impact product launch timelines.

Communication with FDA: Effective communication with the FDA is crucial throughout the PMA supplement process. Challenges may arise in terms of understanding FDA feedback, addressing queries, and ensuring clear communication to facilitate the approval process.

Subjectivity and Lack of Clear Criteria: The criteria for determining whether a device qualifies for this pathway might not be as clear-cut as with other pathways. This can lead to uncertainty for manufacturers seeking to understand the eligibility of their devices.

Lack of Regulatory Precedent: Since De Novo submissions involve devices without a predicate, there might be a lack of regulatory precedent for similar devices. This can make it challenging for both the FDA and manufacturers to establish clear regulatory expectations.

Uncertain Timelines: The timelines for the De Novo process can be variable and less predictable compared to other pathways. Delays in the review process can impact manufacturers’ ability to bring their innovative devices to market in a timely manner.

Eligibility Criteria: Ensure that your device meets the eligibility criteria for the Breakthrough Devices Program. The program is intended for devices that provide substantial improvements in the treatment, diagnosis, or prevention of life-threatening or irreversibly debilitating diseases.

Clinical Evidence Requirements: Be prepared to generate robust clinical evidence demonstrating the safety and effectiveness of your device. The Breakthrough Devices Program often requires high-quality clinical data to support the expedited review process.

Post-Market Considerations: Understand that the Breakthrough Devices Program focuses on pre-market expedited review. After market approval, there may be post-market requirements, and you should be prepared for ongoing post-market surveillance, monitoring, and reporting obligations.

Keira Jessop

Director of Regulatory Affairs

Schedule a meeting with Keira to discuss how AlvaMed simplify the process for FDA submissions.