All "Fda" articles

5 ways to make the FDA audit process easier for your life sciences company

Benjamin Franklin once said that two things in life are certain—death and taxes—and if you’re running a life sciences company, add going through the ...

A guide to writing Corrective and Preventive Action (CAPA) reports

Listen to the audio version of this article read by a real person here (Sound on!): It’s stressful to receive an observation or warning letter from ...

The FDA's approach to digital health technology (DHT) is changing. That's a big deal.

In December 2021, the FDA revealed its draft guidance on "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations".

How Long Does the FDA Medical Device Approval Process Take? [Timeline]

How long before your medical device startup runs out of money? That depends on how long it takes before you start generating revenue. And generating ...

Premarket Notification 510(k) and Premarket Approval

 

What is the FDA 21 CFR? Requirements Overview

What is the best way to ensure that your medical device complies with all applicable laws and regulations?  Title 21 of the Code of Federal ...

5 FDA Audit Preparation Tips for Life Science Startups

Are you preparing for an FDA audit? If so, there's a lot that can go wrong if your organization fails to take the time to adequately prepare. ...

FDA to Issue New Guidance on QMS Validation: 4 Major Changes

Are you having difficulty validating a quality management system (QMS)? As you know, validation provides a level of confidence in the software's ...

5 FDA Pre-Submission Tips for Medical Device Manufacturers

You've just designed the greatest medical device of all-time. Now what? If you've developed a medical device similar to one that's already available ...

A Complete Overview of the FDA 510(k) Process (And How to Shorten It)

Did you know that the FDA rejects more than 75% of 510(k) applicants? Unfortunately, even the slightest delay or setback could spell disaster for ...

What Are The Top FDA Software Validation Requirements? [Review]

Learn about the FDA and its current guidance on General Principles of Software Validation and how it has changed since its initial release date in ...

4 Reasons Overhauling FDA 510(k) is a Great Move

Recent high-profile failures of medical devices have caused harm and injury to patients while damaging the FDA and medical device industry's ...
1 2 Next