Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
Med Device Online

Duty Of Disclosure Considerations For Medical Device Patent Applicants With Parallel FDA Submissions

Understanding the crucial overlaps between FDA disclosures and patent law is important for medical device innovators seeking ...
Medscape

FDA Tightens Approval Process for Radiotherapy Devices

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...