Getting to Yes From FDA
As the co-founder and CEO of FastWave Medical and the founder of Medsider, I’ve spoken to entrepreneurs who have found the regulatory journey to be more collaborative than confrontational.
ISO 80369-7: Changing the Standard for Luer Connectors
ISO 80369 Part 7, the long-awaited replacement to ISO 594, introduced a number of changes to the standard governing dimensions and performance requirements of Luer connectors. Its publication in October 2016 capped a monumental change in the fundamental thinking surrounding devices that transfer liquids and gases in healthcare settings. Despite the Technical Committee’s desire to disrupt as little as possible surrounding the current practices with Luer connectors, ISO 80369-7 still makes many significant changes.
MasterControl Study: FDA, CPSC Recalls Up 115% Since 2018
MasterControl , a provider of quality and manufacturing software solutions for the life sciences industry, has released a new study analyzing five years of product recall data from the Food and Drug Administration (FDA) and Consumer Product Safety Commission (CPSC) showing that recalls have increased more than 115 percent since 2018.
FDA Clarifies Recommendations on Cardinal Health Monoject Recall
The new letter by FDA aimed to expand the recall notice to PCA pumps, which the original recall did not mention. It’s that gap in information that concerned FDA.
FDA Finalize Human Factors Guidance in Combination Medical Devices
Replacing a draft guidance issued in February 2016, FDA recently finalized its guidance on the use of human factors engineering (HFE) in the development of combination medical devices with a drug or biological product.
FDA Hits Integra with Warning Letter
Editor’s note: This story has been updated to include a statement from Integra LifeSciences about the FDA warning letter.
ISO Chemical Characterization for Medical Devices
By comprehensively evaluating the allowed limit of extractable chemical levels in medical devices, manufacturers can ensure that their device is safe for its intended use.
FDA Pilot Program Supports Streamlined Regulatory Submission Processes for Medical Device Manufacturers
The current U.S. regulatory framework for medical devices under the Center for Devices and Radiological Health (CDRH) includes extensive review of test protocols and results for each submission, a process that can be burdensome for both manufacturers and regulatory bodies.
Timeline Mystery for Updated EtO Rules
Thirty-six months (give or take a few) filled with controversy, legal battles, protests, anxiety, anger, and bewilderment—with likely more to come.
FDA updates guidance on identifying and responding to deficiencies
The FDA has revised the guidance document Developi […]
