Regulatory + Quality Assurance | Michelle Lott | lean RAQA

Emergency Use Authorizations: Masks, Respirators

“If somebody asks me about submitting an EUA, I will definitely point them to you. The software – and your counsel – are excellent!!”

– Larry Stevens, RAC
11-year FDA veteran

“I've seen the process. It's slick, efficient, and I can personally vouch for Michelle's work. Start now, be done as early as today!”

- Joe Hage
Medical Devices Group (355,000+ members)

The World Needed Your Masks Yesterday!

The pandemic is not waiting. We need your masks now! People are dying!

That’s why I beg you to accept my help. I spent TWO HUNDRED HOURS wrestling with EUA mask regulations.

Please don’t do that. We don’t have the time!

People think, “Oh, masks, easy.” No, they aren’t!

People think, “Class I Exempt.”

If it’s for healthcare, it’s not exempt.

Even if “exempt,” it’s not exempt from everything!
Fact #1:Most still require recall and adverse events procedures.
Do yours?
Fact #2:Few are exempt from testing prior to importing.
Do yours?

In fact, for a product “so simple,” masks and related personal protection equipment (PPE) are among the most difficult to submit.

The Code of Federal Regulations has 24 unique PPE product codes, many with easy-to-miss differences.

Pick the wrong guideline? Add weeks to your timeline.

I'm telling you, it's a mess.

Please let me help.

This is an emotional issue for me.

Have you lost anyone to coronavirus? I have.

I actually started crying during this webinar about masks.

So will you please let me help
you submit your EUA?


Let me tell you what you'll get:

  1. Review. We'll review your documents and suggest improvements to increase the likelihood you'll win emergency use authorization.
  2. Preparation. We'll assemble your documents and extract your information. We'll enter everything into the correct fields on the various forms for you.
  3. Submission. We'll compose the email communication and submit the completed request to FDA on your behalf.
  4. Delivery. We'll deliver the reply from FDA to you. It will include:
    • The full application;
    • EUA determination;
    • Required procedures; and,
    • Instructions how to fulfill FDA requirements.

* Services beyond these are available for you and would be billed separately.

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