In late November the FDA released two draft guidance documents addressing manufacturer applications for Clinical Laboratory Improvement Amendments (CLIA) waivers for the in vitro diagnostic (IVD) devices. These draft guidance documents propose updates to the 2008 CLIA...
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The FDA Intends to Promote Modern Predicate Devices for 510(k)s
Part of the work in modernizing the 510(k) device approval pathway, first established by congressional amendment of the FD&C Act in 1976 and updated in subsequent amendments, is an examination of how comparison of new devices to older (predicate) devices promotes...
CDER Researchers are Investigating Mass Spectrometry
- for QC of Protein DrugsMass spectrometry has been a critical tool for drug discovery and development since the advent of atmospheric pressure ionization sources (ESI and APCI) in the 1980s. As a mass spectrometry expert, I have been looking forward to the move...
The ClinGen Clinical Genome Resource
Is the First Genetic Variants Database to be Recognized by the FDAOn December 4, 2018, the FDA announced recognition of the ClinGen Clinical Genome Resource as a resource for clinicians and developers of genetic tests. This database is the first genetic variants...
How to Complete Form FDA 3602:
MDUFA Small Business Qualification and Certification for a Business Headquartered in the United StatesQualifying as a small business with the FDA gives a company a substantial discount in the user fees required under the Medical Device User Fee Amendments (MDUFA)....
47 New Medical Devices Approved under PMAs and HDEs in 2018
– Approvals Occurred Between 21DEC2017 and 18SEP2018Each year the FDA publishes data on the devices receiving approval through the various submission pathways. References to much of this information are available in several locations including the Federal Register. In...
Table of Surrogate Endpoints Published by the FDA
Per the requirements in the 21st Century Cures Act, the FDA has published this month the first ever “Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure”. Surrogate endpoints (SEs, not to be confused with Substantial Equivalence for medical...
The PSTC/FNIH Kidney Safety Biomarker
- is a good example of the requirements for qualification under the Biomarker Qualification ProgramThere is considerable public interest in using biomarkers (measurements of substances present in the body or physical health parameters such as blood pressure or changes...