Sens. Johnny Isakson (R-GA) and Michael Bennett (D-CO) have introduced a bill that looks dramatically alter the US Food and Drug Administration's (FDA) process for inspecting device manufacturers.

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

The U.S. Food and Drug Administration (FDA) has published the revised draft guidance “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection,” which, if ...

The US Food and Drug Administration (FDA) saw a 243% spike in the annual number of foreign medical device inspections conducted by agency officials since 2007, according to a new report. “As medical ...

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Senators this week introduced a bipartisian bill that would update the Food and Drug Administration’s process for inspecting medical devices. The bill — sponsored by Sens. Michael Bennet, D-Colo., and ...

An independent watchdog group says the government has quietly scaled back enforcement of federal quality regulations at labs that develop medical devices. Subscribe to read this story ad-free Get ...

This chapter serves as the background for the survey results presented in Chapter 3 and case examples described in Chapter 4. The literature review provides an overview of the use of mobile devices in ...