Compliance Submissions

Posted by Bob Duffy on March 17, 2011 in Regulatory & Standards Compliance

ANSI/AAMI EC13, Compliance Submissions, FDA Guidance Documents, IEC 60601-1

Some things in life are just not rocket surgery – one is product Compliance submissions. Just to clarify, I use the term “Compliance” to mean conformance to a published Standard or set of Standards such as IEC 60601-1, ANSI/AAMI EC13, or FDA Guidance documents. I use this definition to differentiate between Regulatory submissions, which I define to mean conformance to an enacted law or regulation. In practice, Compliance submissions and Regulatory submissions have many similarities, and in some cases are intertwined, such as an FDA Premarket Notification Submission (510(k)).

Here’s the tip: to make the submission process straightforward, I suggest the following steps:

1. Find out what the applicable Standards and/or Guidance Documents are for your product.
2. Get a copy of the applicable Standards and/or Guidance Documents and read them.
3. Evaluate your device against the requirements in the Standards and/or Guidance Documents. Make any updates or corrections necessary.
4. Prepare your submission following the structure and terminology of the Standards and/or Guidance Documents.

I admit this tip seems so obvious one might wonder “what kind of a tip is that?” Well, just like “common sense” (being not so common), I never cease to be amazed how rarely these simple steps are followed.

More details on Straightforward Compliance Submissions

One corollary to these suggested steps is to NOT solely depend on what someone else tells you what a given Standard or Guidance Document requires. Most Standards and Guidance Documents can be easily understood, and there are several reasons to gain your own understanding of the requirements:

1. If you understand the requirements yourself, you can use this knowledge not only in a current submission, but also for future design and development.
2. If you try to understand the requirements yourself, you’ll probably understand 80-90% of it, and thus focus on the parts you don’t understand if you need to seek additional insight. Even then, your question would be “I read section x, and I think it means abc – do I understand that correctly?” rather than “what does the Standard require?”. Since often the best person to ask for additional information is an official person from the agency evaluating your submission, you show a lot more seriousness about intending to comply with the 1st question than with the 2nd.
3. If you understand the requirements yourself, you can use your creativity to find new and novel ways to comply with the requirements.
4. Others’ opinions about what a Standard requires are often just stat – others’ opinions.
5. If you understand the requirements yourself, you not only learn what’s required, but also what’s NOT required. It’s amazing how much folklore there is about what’s “required”.

A second corollary to these suggested steps is to remember that people whose job it is to assess products for Compliance are people. That means that, even if you’re doing your very 1st Compliance submission, you can build a lot of credibility by following these steps to demonstrate a genuine desire to understand the requirements and a sincere intent to meet them. Even after 20 years, I have colleagues I once called up and asked “can you tell me what the applicable Standards are for my device?” Hey, when I don’t know, I still ask that question!

How does one find out what the applicable Standards and/or Guidance Documents are for one’s product? Here are (4) easy steps:

1. Determine where your product is planned to be sold – each market can have it’s own requirements, assessment agency, and submission process.
2. If your company already has a similar product, ask someone in your company:
   1. What’s the official category for your product?
   2. What’s the official classification for your product?
   3. What are the applicable Standards and/or Guidance Documents are for your product?
3. Do a quick internet search to see if there are new Standards or Guidance documents, or new versions of applicable Standards and/or Guidance Documents.
4. Contact the assessment agency(s) if possible to confirm what you think are the applicable Standards and/or Guidance Documents, and submission process.

Following these suggestions won’t necessarily make your submission perfect and issue-free, but it will likely be a shorter submission with far fewer hiccups. Remember, it’s not rocket surgery.