North America

FDA Hits Microlight for Deficient Complaint Handling

The FDA flagged Microlight’s Sugar Land, Texas facility for its complaint handling procedures, in a Form 483 after conducting two inspections. Read More

FDA to Leverage Patient-Generated Data for Medical Devices

Nearly half of clinical trials for medical devices fail to reach their enrollment goals and the FDA wants to know why. Read More

FDA Releases Draft Guidances on Blood Glucose Monitors

The FDA issued separate draft guidances on blood glucose monitors used in health care settings and on over-the-counter products used in the home. When finalized, they will replace guidances the agency issued in 2016. Read More

FDA Plans to Modernize 510(k) Clearance Pathway

The FDA announced a proposed overhaul of its 510(k) review process that would begin with a shift in focus to predicate devices that are ten years old or less. Read More

Health Canada Proposes Streamlined Process for Priority Review Requests

Health Canada is proposing a new streamlined priority review request mechanism that would significantly reduce burdens on devicemakers. Read More

Senate: Naloxone Auto-Injector Price Hike Cost Taxpayers Millions

Kaléo’s massive price hikes for its naloxone auto-injector Evzio have cost taxpayers more than $142 million over the past four years, says a new Senate report. Read More

Failure to Document OOS Results Lands Symmetry Medical 483

Failure to document OOS results and to find the root cause of defects landed surgical instrument and orthopedic implant manufacturer Symmetry Medical in hot water with the FDA following a Sept. 5 to Sept. 10 inspection of its Claypool, Indiana facility. Read More

Heartware Fails to Correct Earlier Warning Letter, 483 Observations

A May 17 to July 12 FDA inspection found that Miami Lakes, Florida-based devicemaker Heartware fell short on repeated quality system observations that were cited in a 2014 warning letter and a 2016 FDA Form 483. Read More

Quality System Failures Plague Texas-Based Ultrasonic Services

Numerous quality system failures were observed at Ultrasonic Services’ Houston, Texas facility during an Aug. 24 to Aug. 27 FDA inspection, after which the devicemaker landed a seven-item 483. Read More

Drug Safety? There (Should Be) an App for That, FDA Says

The FDA is seeking public comment on how it should regulate prescription drug software apps and says some might have to be regulated as a device — such as a software program that uses advanced algorithms to scan skin lesions for evidence of cancer. Read More