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Maquet Cardiovascular received a Form 483 with 17 observations, including several repeat observations related to complaint reporting, process validation, CAPAs and other issues. Read More
In deciding to reorganize the Office of Compliance, CDRH made the pragmatic decision to focus its limited resources on encouraging quality rather than on compliance enforcements, OC Director Steve Silverman says. Read More
The FDA will create a device-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters. Read More
The Centers for Medicare & Medicaid Services seeks industry input as it considers new payment rules and an expansion of the competitive bidding program for durable medical equipment and enteral nutrients, supplies and equipment. Read More
The FDA’s decision to make growth in U.S. clinical trials a high priority is leading to new guidances, shortened approval waits on IDEs and a new position dedicated to handling device trial issues. Read More