In recent weeks, NAMSA has become aware of instances in which U.S. Food and Drug Administration (FDA) CDRH Offices have closed Q-Submissions without review, citing resource constraints stemming from the COVID-19 Pandemic. With the FDA’s commitment to protecting public health, the agency has allocated resources to focus on COVID-19-related activities, working alongside other federal, state and local agencies and officials to address the pandemic.
To better understand the scope and impact of the situation, NAMSA contacted the FDA for further details. FDA staff communicated that the Center for Devices and Radiological Health (CDRH) has received ~5,000 Emergency Use Authorization (EUA) or Pre-EUA applications, with over 500 medical devices and In Vitro Diagnostics (IVDs) achieving approval under EUA to date.
Additionally, the FDA has issued many COVID-19-related policies, templates and guidance documents while hosting numerous webinars to inform industry stakeholders in recent months. These activities, in addition to other pandemic-related tasks (refer to FDA’s COVID-19 Response webpage for more details), have strained the agency’s resources dramatically. While some review offices have been more affected than others, the FDA cites that the following CDRH offices are significantly impacted:
- In Vitro Diagnostics and Radiological Health
- Surgical and Infection Control Devices
- Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
- Orthopedic Devices
- The FDA is reallocating staff from the Orthopedic Devices branch to assist with the workload in other divisions, thus impacting their capacity to review Q-Submissions.
What does this mean for Q-Submissions Moving Forward?
Offices most significantly impacted, as noted above, are employing an algorithm to evaluate Q-Submissions as they are received to determine if they are predicted to be closed without review or accepted. If a product is deemed important to public health, the FDA has communicated that these types of products will likely be accepted for review; Submission Issue Request (SIR) Q-Submissions will not be impacted.
If a manufacturer’s Q-Submission is closed without review, they may submit a supplement to request that the FDA continue their Q-Submission review at a later date, as resources allow. Manufacturers should be prepared for these reviews to take longer than the average 70-day review timeline, with a new expected review timeline of 120 calendar days or longer.
Impact to other Submission Types
Other medical device submission review timelines are dictated by regulation, or through User Fee Agreements with Congress (e.g. IDE, PMA, 510(k), 513(g), De Novo), and will therefore be conducted within legislated review timelines, albeit slower than in previous years. Breakthrough Designation Requests are also predicted to experience slower review processes.
How can NAMSA Help?
If you have a Q-Submission that is to be reviewed by an FDA office that is impacted, you are encouraged to reach out to NAMSA for help with navigating this process. Our Regulatory Team can assist in helping you to evaluate regulatory strategy, determine if a Q-Submission is needed/suggested or liaise with the FDA to identify potential alternative methods to obtain FDA input.
Learn more about NAMSA’s Regulatory Services by visiting us here.
Barbara Atzenhoefer
Barb has over 25 years’ experience within the medical device industry, holding various executive and management positions in regulatory, clinical affairs and quality systems. She has authored over 70 FDA submissions, conducted 40+ international product marketing and registration applications, and developed nearly 45 global regulatory assessments and strategies. Barb currently serves as Principal Medical Research Scientist (Regulatory) at NAMSA.