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October 2019

No. 477

Headlines

Full Issue of The GMP Letter in PDF Format

Download and view the full issue. Read More

FDA’s Top Ten GMP Citations for FY 2019

An FDAnews analysis of the FDA’s Form 483 inspection reports for fiscal year 2019 shows devicemakers continue to be tripped up at the same old hurdles. Read More

EC Releases Guidelines on Benefit-Risk Analysis for Phthalates

The European Commission released final guidelines for devicemakers, notified bodies and regulators on how to perform a benefit-risk analysis for phthalates in medical devices. Read More

FDA Pilots Accreditation Scheme for Conformity Assessment

The FDA is establishing a pilot accreditation scheme for conformity assessment (ASCA) whereby testing laboratories may be accredited by accreditation bodies to assess the conformance of a device within certain FDA-recognized standards. Read More

FDA Issues Warning to Indiana Devicemaker

The FDA issued a warning letter to Polymer Technology Systems — doing business as PTS Diagnostics — arising from an inspection earlier this year of its facility in Indianapolis. Read More

FDA Creates New Safer Technologies Program

The FDA is introducing a new review program for certain medical devices and device-led combination products that are expected to significantly improve the safety of treatments for a disease or condition deemed less serious than those eligible for the breakthrough devices program. Read More

483 Roundup: FDA Hits Six Firms for Quality Management Lapses

The FDA cited six devicemakers for a variety of quality problems uncovered during the agency’s inspections of their facilities. Read More

IMDRF Flags Lack of ‘Global Alignment’ in Cybersecurity

Devicemakers should assess cybersecurity risks throughout the product lifecycle, the International Medical Device Regulators Forum (IMDRF) says, in a new draft guidance that calls for “convergence of global healthcare cybersecurity principles and practices.” Read More