The US Food and Drug Administration (FDA) has released a new guidance document finalizing its recommendations for the medical device industry on how to use Classification Product Codes (CPC), a ...

As the spotlight on foreign drug and medical device facilities brightens because of impurity concerns and a lack of US Food and Drug Administration (FDA) staff abroad, the total number of Official ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

LifeVac has received De Novo classification from the US Food and Drug Administration (FDA) for its suction anti-choking device under 21 Code of Federal Regulations (CFR) 874.5400. The authorisation ...

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...

Devices that are approved through a process that does not require any clinical evidence for FDA authorization should not automatically meet Medicare coverage criteria, which otherwise requires ...

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

Medical device manufacturers developing digital health products face a recurring question: Will the U.S. Food and Drug Administration (FDA) regulate this product? Many digital health products can ...