FDA aims to stay the course in new 4-year plan
July 2, 2014 by Arezu Sarvestani
The FDA today revealed a draft version of its 4-year plan, laying out strategic priorities and goals for keeping patients and consumers safe while addressing industry concerns.
The agency highlighted 5 primary areas of concern: regulatory science, globalization, safety & quality, smart regulation and stewardship. Regulators plan to focus on these areas over the next 4 years in order to help speed innovations to market, provide the public with the best health information and ensure the security of regulated products. Read more
Medical device recalls for June 2014
July 3, 2014 by MassDevice staff
Class I and class II recalls issued by the Center for Devices & Radiological Health in June 2014. Read more
Medtronic issues Class I recall of Duet neuro drainage and monitoring systems
July 2, 2014 by Arezu Sarvestani
The FDA today slapped medtech titan Medtronic with its highest-risk label on a recall of the company’s Duet external drainage & monitoring systems.
The device, part of Medtronic’s Neurosurgery division, helps continuously drain cerebrospinal fluid and monitor intracranial pressure under supervision from a trained clinician. Read more
FDA warns Staar Surgical for missing documentation
July 2, 2014 by Arezu Sarvestani
FDA regulators put the heat on Staar Surgical, revealing a warning letter citing the California company on 15 design and quality control issues.
The observations were made during an inspection of the company’s Monrovia, Calif., facilities earlier this year, where Staar manufactures its intraocular lenses. The warning letter, dated May 21, 2014, was published online on June 26. Read more
FDA clears St. Jude Medical after 2013 warning letter
July 2, 2014 by Brad Perriello
St. Jude Medical said today that the FDA issued clean bill of health for the Sylmar, Calif., plant the watchdog agency flagged in a warning letter early last year.
FDA inspections in the fall of 2012 at the Sylmar facility, which makes St. Jude’s Durata defibrillator leads, turned up 11 problems with quality control and documentation procedures. Read more