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St. Jude’s Sylmar, Calif., plant, which makes most of its CRM products, should soon emerge from an FDA warning letter, CEO Dan Starks said on the company’s earnings call last month. Read More
A recent appeals court hearing on the Securities and Exchange Commission’s conflict minerals disclosure rule provided no immediate relief for manufacturers — though the line of questioning suggested some judges were sympathetic to industry’s free speech argument against the rule. Read More
Medical device companies must include all core data elements for the unique device identification database except those marked “optional,” according to the International Medical Device Regulators Forum. Data elements marked “if applicable” are mandatory in the UDID if the information appears on the product label, IMDRF adds. Read More
The UK’s healthcare cost-benefit watchdog is recommending implantable cardioverter defibrillators as a first-line treatment for people with previous serious ventricular arrhythmia, those with a familial cardiac condition with a high risk of sudden death and patients who have undergone surgical repair of congenital heart disease. Read More
The promising new hypertension treatment known as renal denervation is safe in the short to medium term, but more safety information is needed before conclusions can be drawn about its long-term benefits versus standard care in treating treatment-resistant hypertension. Read More
The U.S. Food and Drug Administration’s new custom device exemption does not apply to 510(k)-cleared devices that are modified but still retain their original intended use and could be clinically studied, the agency clarifies in a draft guidance. Read More
Devicemakers must include information on potential pediatric use in most new device submissions under a U.S. Food and Drug Administration final rule that takes effect April 10. Read More
Manufacturers of partial hip, knee and shoulder implants reclassified from Class IIb to Class III may use summary technical reports as interim evidence for inclusion of their devices in the Australian Register of Therapeutic Goods, the Therapeutic Goods Administration says. Read More
Russian regulators are struggling to create guidance that will implement device registration rules that took effect in January 2013, but have yet to be fully enacted. Read More
Chinese inspectors will focus their reviews on production technologies, raw materials, adverse event reports and a company’s past inspection track record when they conduct quality inspections. Read More