AssurX Blog
Straight talk for regulated industries.
FDA IDE Guidance Offers Industry Important Clarity
In its August 19 guidance for Investigation Device Exemption (IDE) Clinical Investigators, the FDA attempts to better outline its thought process for reviewing, accepting, accepting wi [...]
Cybersecurity & Reliability Assurance Initiatives Top Priority at NERC Board Meetings
NERC held its Board of Trustees (BOT) and Member Representatives Committee (MRC) meetings in Vancouver, BC on August 13 – 14, 2014. The meeting included lively discussions on all the i [...]
FDA Guidance Advises Device Makers to Think About Home-Use
Medical device manufacturers would be well-advised to address any potential home-use product risk at the design stage, says an August guidance from the FDA. As the agency notes, "Failu [...]
FDA Spreads Regulatory Love Nationwide
Detroit may be struggling with bankruptcy, but in a flurry of activity that would make industrialist Henry Ford proud, the local FDA office has been active in our latest warning letter [...]
Time to Take a Closer Look at FDA MDDS Moves
The FDA recently released a new draft guidance document for Medical Device Data Systems (MDDS). The FDA defines MDDS as "hardware or software products that transfer, store, convert for [...]
FDA Lets MDDS Off The Regulatory Hook
FDA won't enforce compliance with regulatory controls that apply to medical image storage devices (MDDS) and medical image communications devices recognizing the "low risk" they pose t [...]
