
FDA to Hold Off on Enforcing New Medical Device Cybersecurity Requirements
Although the law officially took effect on March 29, the FDA says it isn’t planning to enforce the new rules until October 1.
Diagnostic Testing and Emerging Technologies
LAB COMPLIANCE ADVISOR
LABORATORY INDUSTRY REPORT
NATIONAL LAB REPORTER
Although the law officially took effect on March 29, the FDA says it isn’t planning to enforce the new rules until October 1.
In the latest major COVID-19-related enforcement action, 18 individuals were charged in various schemes worth more than $490 million.
Labs must use the new Advance Beneficiary Notice of Noncoverage (ABN) form starting on June 30, 2023, when the old version expires.
Not disclosing list prices of uncovered lab tests on ABN is not consumer fraud, court says.
While labs were absent from recent enforcement actions, last week saw kickback schemes involving DME companies and a medical device company.