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The Utopia Group, a specification developer for an umbilical cord clamp and cutter, received an FDA warning letter for making product changes without following regulations and for lacking a host of procedures. Read More
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