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 ...
Medical News Today

What does FDA approval mean? A guide to understand the process

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

FDA Qualifies MolecuLightDX Wound Measurement as a Medical Device Development Tool (MDDT) for Evaluating New Products in Wound Care

PRNewswire/ - MolecuLight today announced that its MolecuLightDX(R) wound measurement has been qualified by the U.S. Food and Drug Administration (FDA) as a Medical Device Development Tool (MDDT). The ...
JD Supra

FDA's Guidance on the Use of Real-World Evidence for Medical Devices

Recently, the U.S. Food and Drug Administration (FDA) issued a guidance document entitled Use of Real-World Evidence to Support ...
The National Law Review

FDA Final Guidance on PCCP: Streamlining FDA Approval for AI-Enabled Medical Devices

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
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 ...
Healthline

Which Products Does the FDA Regulate?

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...