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Pricing of durable medical equipment, data security and clinical lab test fees are all slated for government scrutiny this year, according to the HHS Office of the Inspector General’s fiscal 2014 work plan. 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 has updated the list of consensus standards it references during premarket reviews. The dozens of revisions touch on areas including software, biocompatibility testing, orthopedics and anesthesia. Read More
The FDA is under fire from a prominent House Democrat for pushing devices through accelerated approval pathways based on limited data, a practice she says could be endangering patients. Read More
Mega Electronics, maker of the FemiScan Home Trainer incontinence device and the ME6000 biomonitor device, received an FDA warning letter for incoming inspection shortfalls and other quality issues. Read More
Invacare says it has made “significant progress” on its FDA consent decree, but must do some additional work on its complaint system before an independent auditor provides final certification to the agency. Read More
Epimed remanufactured products in response to complaints without established production and process control procedures, according to a Nov. 6 Form 483. Read More