The U.S. FDA posted the performance report for the third quarter of fiscal 2020 for third-party review of 510(k) filings. It indicates that 54 filings have been made to third parties thus far in the current fiscal year. Only three third parties have processed five or more filings to date this fiscal year, the same number as in the two previous years, during which between 75 and 80 filings for 510(k)s were processed. The average number of requests per filing fell from 0.57 in FY 2018 to 0.44 in 2019 and stands at 0.24 thus far in FY 2020. Average initial third-party review times have risen from 102 calendar days in FY 2018 to 104 and 111 in FY 2019 and to date in FY 2020, respectively.
Reps. Suzan DelBene (D-Wash.) and Fred Upton (R-Mich.) announced the launch of a bipartisan effort to bolster awareness of the effects of policymaking on med tech with the formation of the Congressional Medical Technology Caucus. DelBene said more than 600 med-tech startups and established businesses are located in the state of Washington, making the Evergreen State “a powerhouse for the discoveries of tomorrow.” Upton said the new caucus “is a major victory for patients, jobs and medical innovation across the country.” The statement notes that jobs in the medical devices and diagnostics industries pay as much as 40% more than the U.S. average.
The FDA said the class I recall of the Glidescope Core One Touchsmart cable by Verathon Inc., of Bothell, Wash., is due to partial or complete loss of image during use. The problem has been reported in association with Core 10 and Core 15 video monitors, and Verathon is said to have received 74 complaints in total. The FDA has received nine medical device reports, although no injuries or deaths have been associated with either the complaints filed with the company or the MDRs filed with the agency.