FDA Now Accepts Small Business Determination Requests Through CDRH Portal

The FDA recently released a significant update to its Center for Devices and Radiological Health (CDRH) Portal, allowing medical device companies to send premarket submissions and Small Business Determination (SBD) requests online. This new feature is a game-changer, especially for small businesses, as it simplifies the submission process, reduces administrative hurdles, and best of all – reduces costs.?

Here’s a breakdown of what this update entails, what it means for small businesses, and how Rook Quality Systems can help you navigate these changes.

What the Update Entails

With this update, medical device companies can now submit premarket submissions and SBD requests directly through the CDRH Portal, which was previously limited to specific functions. The CDRH Portal allows companies to upload necessary documents, track submission statuses, and receive updates directly from the FDA.

Key highlights of the update include:

• Online Premarket Submissions: Companies can now upload various types of premarket submissions, such as 510(k), De Novo requests, PMA (Premarket Approval), and HDE (Humanitarian Device Exemption).
• Small Business Determination (SBD) Requests: Small businesses seeking fee reductions or exemptions can apply for SBD status online, streamlining the process for obtaining significant savings on FDA user fees.
• Real-time Status Updates: The Portal provides real-time tracking of submissions and responses, giving businesses transparency and immediate feedback from the FDA.

What This Means for Small Businesses

For small medical device companies, this update is especially beneficial. SBD requests are crucial because qualifying for SBD status can lead to substantial fee reductions, making it easier for small businesses to bring innovative medical devices to market. The updated Portal now allows companies to submit these requests digitally, improving accessibility and turnaround times.

Additionally, small businesses often face resource limitations, which makes managing complex FDA submissions a challenge. The ability to track submissions in real time and submit online removes some of the paperwork burden, making the overall process more efficient.

Benefits of the New CDRH Portal Update

The new update to the CDRH Portal offers several advantages, particularly for small and medium-sized enterprises (SMEs):

• Faster Processing: Electronic submissions speed up the initial review process and reduce delays caused by manual paperwork.
• Cost Savings: For businesses that qualify for SBD status, the ability to apply online means faster determinations and quicker access to fee reductions.
• Transparency: The real-time status updates give companies more control and insight into where their submission stands, allowing for quicker responses to FDA requests.
• Increased Accessibility: Small businesses now have a user-friendly online platform to manage both their premarket submissions and their SBD requests, removing some of the bureaucratic hurdles previously associated with these processes.

Who is Eligible?

Any medical device manufacturer or specification developer can use the CDRH Portal for premarket submissions. However, only businesses that meet the FDA's criteria for a small business are eligible for SBD status. If granted, small businesses can receive substantial discounts on premarket submission fees.

To qualify for SBD status, businesses must:

• Have annual gross receipts of no more than $100 million, including affiliates.
• Submit their financial documentation for verification as part of the SBD request process.

How Rook Quality Systems Can Help

At Rook Quality Systems, we understand how daunting premarket submissions can be, especially for small businesses navigating regulatory challenges for the first time. Our team of regulatory experts can support you by:

• Preparing Your Submissions: We assist with drafting and organizing all necessary documentation for FDA premarket submissions, ensuring compliance with the latest requirements.
• Small Business Determination Requests: We help determine your eligibility for SBD status and manage the submission process on your behalf.
• Navigating the CDRH Portal: We guide you through the updated CDRH Portal, ensuring that your premarket submissions and requests are processed efficiently and on time.
• Ongoing Compliance Support: We don’t stop at submissions. Rook continues to work with you post-submission, assisting with any follow-ups and ensuring that your devices meet all FDA requirements.

In conclusion, the FDA’s update to the CDRH Portal is a major win for small businesses in the medical device industry, making it easier to submit premarket applications and request SBD status. With these new efficiencies in place, small businesses have a greater chance of bringing innovative products to market faster and more affordably.

Rook Quality Systems is here to help you every step of the way, from preparing your submissions to navigating the new online portal. Let us handle the regulatory complexities, so you can focus on what you do best — innovating.