The way we live today is intrinsically tied to data. From the prescriptions we receive at the hospital and the glucose meters we use at home to the ECG features on our smartwatches and the records in our health apps—we are constantly generating a stream of "real-world data." Crucially, this data is now moving beyond simple record-keeping. Recent news indicates that this real-world data can serve as compelling evidence to support new product approvals (or regulatory reviews).

Major foreign news outlets, including CNN, are reporting that the US federal government shutdown is finally nearing its end. While an official termination announcement has not yet been made, the normalization of government operations is imminent. Once federal agency operations resume, medical device registration and renewal processes, which had been suspended, will fully restart. This period is historically the time when system delays and errors are most frequent, as companie

The recent failure of the U.S. federal government to reach a budget agreement has led to a government 'shutdown'. While we're used to...

Have you ever had a seemingly perfect product unexpectedly delayed or detained at customs? One of the most common reasons for this is a...

April 14, 2025 The FDA has cleared the Dexcom G7 15-Day Continuous Glucose Monitoring (CGM) System, marking a significant milestone in...

March 21, 2025 The U.S. Food and Drug Administration (FDA) has recently mandated a comprehensive return-to-office policy, requiring...

Monday, March 17, 2025 Introduction In the fast-paced world of medical technology, innovation often races ahead of regulation. Dexcom , a...

February 4, 2025 Responsibilities of an FDA Initial Importer When importing medical devices into the United States, manufacturers must...

February 3, 2025 Why Choosing the Right Initial Importer Matters Selecting the right FDA Initial Importer is a critical decision for...

January 31, 2025 Understanding the Role of an FDA Initial Importer For foreign medical device manufacturers  looking to enter the U.S....

January 30, 2025 Keyword Phrase:   FDA Initial Importer Requirements Understanding the Role of an FDA Initial Importer If you manufacture...

January 29, 2025 Keyword Phrase:   FDA Initial Importer If you're a foreign manufacturer looking to sell medical devices,...

January 10, 2025 Importing medical devices into the United States is a complex process that requires strict adherence to regulations set...