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A 12-item 483 documents a litany of quality system failures the FDA found at Diasol East of Watertown, Tenn., during an Aug. 7 to Aug. 22 inspection. Read More
Final guidance issued by the FDA on Friday outlines what devicemakers should know about manufacturing site changes and when they should submit supplements. Read More
Lax medical device reporting and CAPA procedures as well as a host of other quality issues were uncovered during a July 31 to Aug. 2 FDA inspection of LED Intellectual Properties’ Irvine, Calif. facility. Read More
FDA Commissioner Scott Gottlieb said the agency plans to release more details in the coming weeks about its precertification program for digital health technology, including details of the agency’s testing plan for products in 2019. Read More
The FDA issued final guidance on user fees and refunds for device biologics license and premarket approval applications with just minor changes from the October 2017 draft. Read More
The FDA cited devicemaker Streck for failing to document certain design elements for its Cyto-Chex blood collection tubes, serving the company a Form 483 after a September inspection of its La Vista, Nebraska facility. Read More
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
The FDA granted an emergency use authorization (EUA) for a single-use, rapid fingerstick test for the Ebola virus, only the second test of its kind made available under an EUA. Read More
The FDA issued a warning letter to US Vascular for failing to correct deficiencies in its complaint reviews and to fix problems with medical device reporting, among other violations. Read More
The FDA posted an update on its Accreditation Scheme for Conformity Assessment (ASCA) pilot, which aims to streamline conformity assessments for medical device submissions that meet yet-to-be-announced standards. Read More
Failure to establish a design history file or to put procedures in place to control device history records, in addition to failure to conduct quality reviews, landed devicemaker LSVT Global a 10-item Form 483 following a July 16 to July 17 inspection of is plant in Tucson, Arizona. Read More