FDA Regulatory Services

GAP Analysis

Our GAP analysis services are designed to offer a streamlined pathway to ensuring FDA submission success. By conducting thorough assessments of your device documentation and identifying any potential gaps, we can ensure 100% alignment with the FDA’s requirements. 

Through this comprehensive analysis, we can also provide actionable insights and recommendations to prevent any other potential regulatory issues you might face later on. This can then allow you to optimise your submission strategy and enhance the efficiency of the regulatory approval process. 

510(k) Submissions

Many FDA devices require a 510(k) application submission before being placed on the US market. With specialist knowledge of medical devices, our team can guide you through this process and help you enter the market more quickly. 

We can also minimise any potential risks you might face along the way, such as Refuse to Accept (RTA) notifications or any requests for Additional Information (AI) during the FDA submission review process. 

Working with us will involve several key steps to approach your 510(k) successfully. These include: 

• FDA product code, regulation number and predicate device identification. Selecting the correct predicate device for a device 510(K) application is crucial for ensuring faster market entry. In doing so, this will help streamline testing requirements and improve your likelihood of reaching the market successfully. 
• Confirm testing, regulatory pathway and clinical data requirements. Having a clear understanding of your testing needs will help ensure compliance with regulatory standards, streamlining the submission process and increasing your likelihood of success. During this stage, our consultants will research all of the relevant FDA guidance documents, including the ever-evolving Special 510(k), Abbreviated 510(k) and Safety and Performance submission pathways, to provide clear recommendations tailored to your specific device type and overall business objectives.  
• Gap analysis. After identifying your requirements and conducting a thorough assessment of your existing documentation, we’ll provide you with a comprehensive gap analysis report. This will highlight all of the key data required to submit a successful 510(k).
• Complication and submission of your 510(k). Once we’ve gathered all of the necessary data and have completed the required testing components, our FDA consultant will complete your 510(k) submission. This will then be sent to the FDA, with any follow-up questions they have handled by our team of specialists. 

Breakthrough Devices Program Submission

A streamlined FDA process for innovative medical devices and combination devices, the Breakthrough Devices Program will involve submitting documentation to demonstrate your device’s potential to address unmet medical needs. If approved, your review and entry into the US market will be prioritised. 

Our expert team can streamline this FDA submission process, guiding you through every stage – from understanding the qualification criteria to preparing your strategic documents. By working with our team, you can trust us to propel your innovative medical devices to market sooner, rather than later. 

De Novo Submission

A De Novo submission is an FDA regulatory pathway required for novel medical devices that are ineligible for the traditional 510(k) pathway as they don’t have a comparable predicate in the market. 

Typically reserved for low to moderate-risk devices, the De Novo process involves a comprehensive request to the FDA and is often required in two main situations. The first is when the FDA deems your 510(k) submission to be Not Substantially Equivalent (NSE) and the second is if there is no legally marketed predicate device for 510(k) reference at the project’s outset.

Our team of experts can guide you through both of these situations, helping educate you on the De Novo pathway and your understanding of how it applies to your specific device or product.

IDE clinical study submissions and reports

Established by the FDA to facilitate clinical investigations of medical devices, an Investigational Device Exemption (IDE) is a regulatory framework that’s needed when medical devices are in their initial stage of development and need to have their safety and efficacy evaluated through clinical trials.

During this application, you will be required to provide comprehensive details about the device and the proposed clinical study protocol. We can help with this, especially with the following processes: 

• Pre-submission meetings
• Risk determination
• Documentation compilation
• Early feasibility studies (EFS)
• Progress reports

Premarket Approval (PMA) Submissions

If your medical device has a high level, or class III, level of risk, you will require a Premarket Approval (PMA) submission. 

Unlike the 510(k) pathway, the PMA process is more rigorous and will involve comprehensively reviewing scientific and clinical data to ensure its safety and efficacy. It will also involve the auditing of your manufacturing facilities, to ensure complete compliance with FDA regulations. 

Following your approval, you will also be obligated to submit annual reports to the FDA, with ‘PMA supplements’ required for any significant changes you make to a device or any claims you make around its use.  

At Apotech, we can support you throughout this entire process and help you in a number of different ways. Our services include:

• Pre-submission consultation. We can guide you through the crucial pre-submission phase, addressing any key issues and engaging in discussions with the FDA to ensure a well-prepared final submission.
• PMA compilation. Our team can assist you in thoroughly compiling all of the required PMA sections.
• Preclinical testing management. We can facilitate and oversee the necessary preclinical testing to meet strict FDA regulatory standards. 
• Clinical investigation support. Our consultants can offer advice and support on clinical investigations wherever you are in the world.
• Advisory panel meeting assistance. We can prepare and represent manufacturers for advisory panel meetings, ensuring a comprehensive and effective review process.
• PMA supplements and annual reports. Our experts can assist in the preparation of PMA supplements and annual reports.

Q-submissions. We can support you throughout the FDA’s Pre-Submission (Q-Sub) process to gain valuable insights when formalising your submission.

Q-Submissions

Our team can expertly guide you through the FDA’s Pre-Submission (Q-Sub) process – a crucial step that medical device manufacturers can use to engage with the FDA and seek valuable feedback before gaining regulatory approval. 

As experts in mitigating risk, asking precise questions and accelerating the approval process for your 510(k) applications, De Novos and PMAs, we can also harness our existing relationships with the FDA to lead agenda-setting and discussions effectively.