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December 2018

No. 467


Full Issue of The GMP Letter in PDF Format

Download and view the full issue. Read More

FDA Extends UDI Deadlines Another Two Years for Class I, Unclassified Devices

The FDA said it will allow device manufacturers of Class I and unclassified devices another two years to comply with its unique device identification system requirements, which are being phased in over seven years. Read More

CDRH Posts New Timeline, Update on Medical Device Testing Accreditation Pilot

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

Warning Letter Roundup: Three Firms Cited for Adulterated Devices

The FDA hit three foreign device manufacturers with warning letters, calling the firms out for quality system violations that led to adulterated products. 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 software applications 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

483 Roundup: FDA Cites Firms for Quality, Risk Analysis and SOPs

The FDA flagged seven devicemakers for quality system and other failures observed during inspections. Read More

FDA Issues Updated Medical Device Safety Action Plan

The FDA plans to continue building out its National Evaluation System for health Technology (NEST) and it is increasing its focus on device therapies unique to women, Commissioner Scott Gottlieb and CDRH Director Jeff Shuren said in a joint announcement. Read More

FDA Issues Updates on Overheating Problems in MR-Guided Lasers

Monteris is releasing a new version of its NeuroBlate probe to address a problem with overheating of its magnetic resonance-guided laser thermal therapy device. The new probe is equipped with a non-metallic fiber optic sensor. Read More

FDA Reconsiders Electronic Labeling for Certain Devices

The FDA has withdrawn a proposed rule that would have required manufacturers to submit labels and package inserts in electronic format for certain home-use medical devices. 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 Asks Industry to Help Define Servicing and Remanufacturing

The FDA is seeking feedback from devicemakers to help craft guidance on the difference between servicing and remanufacturing devices. Read More