Light Age, a New Jersey-based manufacturer of Class II medical lasers, drew an FDA warning letter for 12 different violations flagged during a fall 2017 site inspection. Source: The GMP…

The FDA issued draft guidance to provide updates on in vitro diagnostics’ replacement reagents. Source: The GMP Letter

The International Medical Device Regulators Forum released new guidance to help global regulators, conformity assessment bodies and industry assess whether a medical device conforms to regulations in each jurisdiction. Source:…

The FDA issued “immediately in effect” guidance for manufacturers of Class I and unclassified medical devices on compliance dates for meeting unique device identification requirements. Source: The GMP Letter

The FDA said in a new draft guidance a “least burdensome” approach should be applied throughout the medical device total product lifecycle, rather than just in premarket activities. Source: The…

Australia’s Therapeutic Goods Administration saw a significant increase in adverse event reports for medical devices in 2016 — logging 3,841 AERs compared with 3,359 the previous year — according to…

The FDA flagged 13 devicemakers for serious deficiencies including inadequate reporting of adverse events, and CAPA nonconformities. Source: The GMP Letter

CDRH is proposing a new industry program for reporting certain medical device malfunctions. Source: The GMP Letter

Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate validations, designs and device history records. Source: The GMP Letter

The recent ransomware attacks in the U.S. healthcare industry have highlighted the need for increased product security for medical devices, the American Hospital Association said in a letter to the…