May 5, 2022

As the US Food and Drug Administration (FDA) prepares to transition from its COVID-19 public health emergency (PHE) protocols, a number of challenges for medical device manufacturers will emerge. Let’s look at three priorities you should plan for in order to be ready to achieve your speed-to-market goals.

1. Emergency Use Authorizations - During the PHE, the FDA announced temporarily reduced requirements to bring various medical devices to market more quickly to address the pandemic. Many of the manufacturers of these devices would have normally been required to submit a 510(k) before marketing their devices. For some, the FDA placed devices under temporary enforcement discretion, including air purifiers and digital devices to treat psychiatric disorders. For other devices, the FDA required an Emergency Use Authorization (EUA) be issued before marketing. This included devices such as diagnostic tests for SARS-CoV-2 (the virus that causes COVID-19), certain masks, respirators and ventilators. 

Emergo expects: The FDA will finalize these transition guidance documents in the next few months. Many manufacturers who want to retain US market access will have to submit 510(k)s. 

Action item: Going forward, the FDA is only accepting certain EUAs for review based upon devices that are in short supply. If your device is not among those with identified shortages, you may be subject to the normal FDA approval process. In order to avoid processing delays, check now to see what regulatory pathway you may need to follow to keep your device on the market.

2. MDUFA V – Medical device application fees were introduced in 2002, under the Medical Device User Fee Amendment. The current amendment, MDUFA IV, is set to expire in September 2022. The agency is currently finalizing the process improvements detailed in FDA Medical Device User Fee Amendment V (MDUFA V). Once adopted, MDUFA V will set performance goals and procedures for medical device submissions for the fiscal years 2023 through 2027. 

Emergo expects: Congress will likely make a concerted effort to implement the agreement before MDUFA IV User Fees expire. What will happen if MDUFA V is not implemented before MDUFA IV expires? 

Action item: The best advice is to be prepared. The decision goal under MDUFA V is for the FDA to complete a review within 150 calendar days for 70% of De Novo (devices with no predicate on the US market) submissions. To avoid expected bottlenecks, it’s best to submit early.

3. Cybersecurity – Questions related to cybersecurity continue to be seen. These generally revolve around documentation not appearing clear and/or sufficient. The FDA will look for plans for bug detection, risk assessment, detailed security labeling and evaluation of known vulnerabilities. 

Emergo expects: Cybersecurity to continue to be a priority in FDA medical device reviews. 

Action item: Emergo recommends including overview tables to describe cybersecurity documentation to ensure that the FDA reviewers can understand from a high level and find the information needed to complete the review. Make sure all the necessary cybersecurity documentation, as outlined in FDA documents, is provided and complete.

Watch our webinar for more on what to expect from the FDA in 2022.

Learn more about US FDA regulatory requirements at Emergo by UL:

  • FDA medical device classification consulting
  • Whitepaper: FDA regulations for novel and innovative medical devices
  • Medical Device Cybersecurity for Network Connected Software and Devices services

Author

  • Kathryn Burke's picture
    Kathryn Burke

Related