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FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren hailed the “reimagination” of health care delivery through mobile medical apps and cited steps the agency is taking to encourage innovations in the rapidly developing market. Read More
The FDA issued two new guidances for sponsors of products designed to treat hay fever as well as other cold-like symptoms that aren’t caused by allergies — and said it considers the delivery system for a topical drug as part of its review, so the whole product is evaluated as a hybrid drug/device. Read More
AdvaMed is paying close attention to an initiative by HHS that could impact pricing arrangements for medical devices by adding safe harbors to the federal anti-kickback statute. Read More
Failure to maintain complaints from 2014 to 2017 landed Phoenix, Arizona-based Gergens Orthodontics Lab a Form 483 following a May FDA inspection. Read More
Failure to establish design controls, acceptance procedures or a quality policy for its MiBo Thermoflo Class II device landed specification developer and manufacturer Mibo Medical Group a Form 483 following a May inspection of its Dallas, Texas facility. Read More
Industry stakeholders lauded the FDA’s efforts to make greater use of real-world data and to take a total product lifecycle approach to regulation as outlined in its proposed Medical Device Safety Action Plan. Read More