- FDA’s most recent quarterly report on device submission and authorization trends reveals the rate of major deficiency letters to original PMA applicants during the first review cycle was again on the rise during the second quarter of the agency's fiscal 2020, or Jan. 1 to March 31. Three out of every four companies seeking the approval reserved for more complex, higher-risk devices were hit with a major deficiency letter during the first cycle, up slightly from 73% during 2019 and 63% in 2018, having fallen from a recent high of 91% in 2016.
- The rate of 510(k) submissions receiving an additional information request during the first review cycle flatlined at 63%, the same as last year and one percentage point below 2018's rate.
- The number of original PMAs awarded during the period fell slightly from nine the prior year to seven, as did De Novo authorizations, down from seven to four, according to FDA databases.
Seven weeks ago, FDA Commissioner Stephen Hahn said in an update to industry that the agency's Center for Devices and Radiological Health continued to meet its review time goals set forth by the Medical Device User Fee Amendments amid the pandemic, but acknowledged potential for that to change, particularly with staff being pulled into COVID-19 work on pre-emergency use authorizations, EUAs, and immediately in effect guidance documents. Hahn also noted that extensions to response due dates on certain marketing applications could contribute to future slowdowns.
The most recently posted MDUFA IV quarterly performance report offers a small slice of data on how medical device submissions may be impacted during the pandemic. Two-thirds of the second quarter of FDA’s fiscal 2020 occurred under a state of public health emergency, which the Department of Health and Human Services declared Jan. 31 in regard to the novel coronavirus. Widespread remote work policies and major shifts in the U.S. economy did not take hold until there were about two weeks remaining in March.
Given that timing, it’s likely trends in the length and volume of device reviews during the pandemic compared to prior years won't be parsed out until later reports are issued. The same fiscal second quarter period last year faced its own form of disruption: the 35-day government shutdown beginning Dec. 22, 2018, and extending through Jan. 25, 2019.
Regardless of whether or not the agency can stick to review timelines set forth in user fee agreements, it's unclear whether the pandemic would also change the number of submissions going into the agency, as a result of financial changes at companies or shifts in clinical trial or marketing timelines.
The agency issued 23 medical device-related guidance documents during the period, 10 more than it noted in last year’s version of the report, but that difference is due to newly issued and updated guidances pertaining to the pandemic.
As FDA hit the halfway mark of fiscal 2020, the agency appeared to still have many final and draft guidances to get to from the list of priorities it laid out months ago. Final guidance topics still outstanding include the Safer Technologies Program for Medical Devices; Labeling Recommendations for Surgical Staplers; Clinical Decision Support Software; and Multiple Function Device Products.
With the exception of a draft guidance on breast implant labeling, the rest of the documents prioritized in the draft guidance section appeared to still be in progress, including Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Distinguishing between Medical Device Servicing and Remanufacturing; and Unique Device Identification: Policy on Enforcement of GUDID Submission Requirements for Certain Class I Devices.
Negotiations for the next version of MDUFA was slated to begin this spring, but a public meeting hosted by FDA to kick things off was postponed due to COVID-19.