Surgical Mask Guidance

Surgical Mask EUA During the COVID-19 pandemic, the FDA issued Emergency Use Authorizations (EUA) for certain Personal Protective Equipment (PPE), including Surgical Masks.  Normally a FDA 510K Premarket Notification is required prior to marketing a mask as a Surgical Mask.  This is still a long term requirement.  However, due to the issuance of the Umbrella…

Read More

Pain is Weakness Leaving the Body!

Pain is Weakness Leaving the Body! I love this old military mantra!  Or then there’s “No pain no gain!” Sometimes a little bit of pain goes a long way for ultimate success! We accept this mantra at Quality Audit Consulting (QAC)! We can help you get through your growing pains with a gap assessment for…

Read More

N95 Respirator Test Requirements for NIOSH Submission

N95 Respirator Test Requirements for NIOSH Submission NIOSH requires that N95 manufacturers follow the guidelines in the Code of Federal Regulations (CFR), 42 CFR Part 84. 42 CFR Part 84 provides the test procedures, requirements, and documentation needed to file an application with NIOSH Before respirators can be submitted to NIOSH for certification, manufacturer’s must…

Read More

NIOSH and N95 Respirator Certification Steps

The FDA defines N95 Respirator as a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles.  The edges of the respirator should be designed to form a seal around the nose and mouth. Surgical N95 Respirators are commonly used in healthcare settings and are a subset…

Read More

Quality System Requirements, N95 NIOSH Approved Respirators

Quality System Requirements, N95 NIOSH Approved Respirators is required by the FDA.  FDA enforcement of normal requirements for Face Masks and N95 Respirators has relaxed during the COVID-19 Global Pandemic. On April 2020 (revised on May 2020) the FDA issued Guidance “Enforcement Policy for Face Masks and Respirators During the Corona Virus Disease (COVID-19) Public…

Read More

Hand Sanitizer Requirements, COVID-19

The COVID-19 Pandemic has brought the issue of hand sanitizer requirements and their regulation to the national forefront.   Because of the public health emergency, the FDA has stated that they do not intend to take action against firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs…

Read More

Metrics, the Foundation and Emotions

Metric Reporting

Metrics, This one word can cause many emotions, fear, trembling, excitement, or dread! I have experienced all of these emotions when it comes to metrics. That Pareto Chart ascending or descending in at a particular elevation or curve can have a profound effect upon us! The FDA has recognized the importance of Quality Management System…

Read More