Thegmpletter

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February 2018

No. 457

Headlines

Full Issue of The GMP Letter in PDF Format

Download and view the full issue. Read More

FDA Sets UDI Compliance Deadline for Class I, Unclassified Devices

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. Read More

IMDRF Updates Device Safety and Performance Assessment Guidelines

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. Read More

FDA Drafts Guidance on Replacing Reagents for IVD Devices

The FDA issued draft guidance to provide updates on in vitro diagnostics’ replacement reagents. Read More

Medical Laser Manufacturer Draws Lengthy FDA Warning

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. Read More

FDA Warns BD Facility in Ongoing Lead Test Probe

The FDA issued a warning letter to Becton Dickinson for distributing adulterated and misbranded devices, among other significant GMP violations, as part of its ongoing investigation of inaccurate blood lead test results associated with Magellan’s LeadCare test systems. Read More

FDA Warns Oregon Device Firm Over Failing to Respond to Inspection Issues

Biomodeling Solutions drew an FDA warning letter after it failed to provide written responses to nonconformities identified in a Form 483. Read More

Regulatory Hurdles for Design Changes Stall BSI’s Market Comeback

Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Read More

483 Roundup: FDA Flags 8 Device Firms for Numerous Deficiencies

The FDA cited seven U.S. devicemakers and one in Japan for various noncompliances with regulatory requirements, including inadequate complaint investigations. Read More