Simplifying Global Compliance
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December 2018
No. 467
Headlines
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The FDA has withdrawn a proposed rule that would have required manufacturers to submit labels and package inserts in electronic format for certain home-use medical devices.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
