Advamed urges administration to communicate on DPA
The Biden administration posted an executive summary for the national strategy for the COVID-19 pandemic, which calls for exercise of the Defense Production Act (DPA) to bolster production of vaccines, tests and personal protective equipment. The DPA will also be invoked to address shortages of supplies such as dead-space syringes for vaccine administration, along with testing sample collection swabs and reagents. The Advanced Medical Technology Association responded in a Jan. 22 statement noting that the Trump administration had invoked the DPA, and that those experiences highlighted that the DPA “can be an effective tool in some cases and disruptive in others.” That statement was attributed to Advamed President and CEO Scott Whitaker, who urged the White House to communicate directly with individual companies before acting on DPA declarations.
FDA posts third-party report for Q1, FY 2021
The U.S. FDA posted a performance report for third-party reviews of 510(k) filings for the first quarter of fiscal 2021, which said that only one of the third parties thus accredited reviewed more than five submissions to date in the current fiscal year. Third parties have accepted 27 filings to date in FY 2021, 10 of which have been completed, each within 30 days and each with a finding of substantial equivalence. Ten of the 27 filings were met with requests for additional information.