Knowledge Center

Writing your 510(k) Doesn’t Have to be Expensive or Risky

Medical Device DocumentationIf you are doing anything innovative in the life sciences industry, you should be familiar with 510(k) documentation required by the Food and Drug Administration (FDA).

You are familiar with the 510(k), right? If not, take a look at the regulations. Fair warning: your eyes likely will start to cross in 30 seconds or so. New products (and even improvements to existing products) in the life sciences industry are governed by the 510(k), which is required for new or modified devices, drugs, products, software, and even new or modified claims or uses. Everything from catheters and alcohol rubs to CT machines and drugs are subject to the 510(k).

Startup companies, especially, must be aware of the documentation requirements at the front end of their development efforts. Documentation is required before you start building your new wonder drug, device or app, although few start the documentation as early as they should.

If you’re tempted to procrastinate, just be aware that both your development and your documentation are required to proceed in a proscribed order and that anything you do out of order or without the requisite accompanying documentation could be disallowed, meaning that you might be forced to repeat it. In other words, requirements and intended function and use must precede design and testing. You can’t simply build something, write down what it does and then call that functionality the “requirements” or write down how it works it and call that the “design.”

When it comes to 510(k) documentation, you have five choices:

  1. Hire full-time help. That’s a great option – if you can afford it. But in a startup where you’re working toward your first submission, it probably doesn’t make financial sense. People who shine at taming complex documentation like this are hard to find and command premium salaries. The also-rans don’t know what they are doing, which creates unnecessary work for your company and still may not get that 510(k) filed.
  2. Do it yourself. Take another look at those regulations. They are complex and maddeningly time consuming. Submitting a 510(k) correctly the first time requires years of specialized experience. Do you do your own accounting, or have you hired a CPA? Same thing, here. Your time and talents are better spent developing your products and your business instead of filling out paperwork that’s difficult to understand and even more difficult to file correctly the first time.
  3. Hire an attorney. If your business is of any size, you probably already have a relationship with a law firm and you are well aware of what you’re paying for legal services. Given the specialized skillset required to successfully file 510(k) documentation, can you afford to have an attorney do this? There definitely are more cost-effective (and generally effective) options.
  4. Do nothing. Shockingly, some companies actually take this approach. Bad idea. Very bad idea. Last year a medical device company was fined $80 million and its former CEO fined and given a two-year prison sentence for failing to receive approval for a device used in conjunction with knee-replacement surgery. That may be an extreme case, but the FDA takes this documentation seriously. And you should, too.
  5. Hire a quality and regulatory specialist. This solution ticks both of the boxes that really count: job done right at a price you can afford. These specialists offer 510(k) documentation services that help companies understand where they are from a documentation standpoint and what needs to be done to complete the application, including any testing that may be required.

Most companies that call Provaré have already tried some combination of the first four options and haven’t had success. Shouldn’t you just skip the painful intermediary steps and get the help you need the first time?