AdvaMed
Biden Administration Details Expanded Testing as Part of Broader COVID-19 Action Plan
President Biden said he would use the Defense Production Act to expand manufacturing of rapid point-of-care and at-home COVID-19 tests, among other initiatives. Â
AdvaMed Partners With Dx Companies to Create National COVID-19 Supply Registry
According to the registry's first dataset, more than 65 million tests have been manufactured and shipped across the US.
Congress Introduces VALID Act for Diagnostics Regulation
The bill, which was introduced in the House and Senate, would resolve longstanding questions around the FDA's authority to regulate laboratory-developed tests.
Bill to Delay, Revamp PAMA Lab Payment Reporting Introduced in Congress
The bipartisan legislation would delay the reporting of lab payment data by a year and collect recommendations on improving PAMA payment reporting requirements.
Under a separate initative, the FDA would give device makers the option of demonstrating substantial equivalence to performance criteria, rather than to a predicate device.Â