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Replacing a draft guidance issued in February 2016, FDA recently finalized its guidance on the use of human factors engineering (HFE) in the development of combination medical devices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 Developing and Respondi
