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Devicemakers should never be concerned that an FDA inspector will cite them for opening “too many” corrective and preventative actions, a CDRH official says. Read More
The device industry is asking the FDA not to impose controls, including quality system regulations, on manufacturers of low-risk health information management software that doesn’t serve a clinical function. Read More
Manufacturers of some types of durable medical equipment could see their Medicare and Medicaid reimbursement rates cut by more than a third if a proposed rule to expand the government’s DMEPOS competitive bidding program nationally takes effect. Read More
Patient groups and FDA advisory panel members sparred over whether a controversial treatment for uterine fibroids should be removed from the market, with the former claiming that power morcellators pose a serious health risk and some panelists saying the risks have been overstated. Read More