FDA 510(k) or CE Marking?

Today’s guest post comes from Rob Packard. Rob is a Regulatory Affairs and Quality Management System expert whose specialty is helping companies with regulatory submission of a Design Dossiers for CE Marking of high-risk Class III medical devices. You can read more of Rob’s work (and his colleagues) at Medical Device Academy blog

I’ve read a few business plans that propose to obtain a 510(k), CE Marking and a Canadian Medical Device License all in six months. My first impression is, “Lots of Luck!” Often I will ask how many people are working on this ambitious regulatory project. If the answer in “one”, they haven’t even got a clue. For a low-risk device this MIGHT be possible, but there are “If” qualifiers:

  1. If the device is a Class 2 device in the US requiring a 510(k), and the device is extremely similar to the predicate device, the 510(k) might get approved within 90-120 days.
  2. If the device is a Class IIa device in Europe, an expedited review ($$$) can be as short as 90 days.
  3. If the device is a Class 2 device in Canada, a Medical Device License can be approved in less than 60 days.
  4. If the company has already completed all the verification and validation testing, including any electrical safety and shelf-life testing, a regulatory expert can assemble a submission for all three markets in less than 60 days—assuming the design team has already written most of the documentation.
  5. If the regulatory expert has successfully submitted multiple applications to each of these markets previously, they will have templates to work from and know exactly what each country wants—including formatting.
  6. If the company already has a registered Quality Management System (i.e. – ISO 13485:2003 with CMDCAS), then they won’t need to have a Phase 1 audit, open a bunch of CAPAs, have a Phase 2 audit, and open some more CAPAs.

On rare occasions a motivated team can accomplish the impossible. For example, I started helping a team last year around August 1st. The team was half-way done with their Technical File for CE Marking, already had a 510(k), and they had just finished a pre-assessment audit for ISO 13485. After an obscene amount of work, we achieved CE Marking of their Class IIa device by mid-November (~100 days). CMDCAS and a Canadian Medical Device License application would have killed us, so we postponed that goal for this year.

Why would you want to commit your team to such a ridiculous goal of 3 regulatory approvals in a 6-month period?

The answer is that most companies have the common sense not to. Instead, most companies pick one market and focus on that. Most US-based companies pick the US market and submit a 510(k) first. Why?!

The 510(k) process is harder than CE Marking, new technology takes three years longer on average to get approved in the US than Europe, and the rules change faster than the US FDA publishes guidance documents to explain what they are doing.

Canada is the least rigorous of the three markets I mentioned (If you really want easy, New Zealand only requires registration—there is no “approval” at all for that market.). The Canadian market is 10% of the US Market size, and New Zealand is…well not worth comparing. Europe, however, is a big market.

Most small and mid-sized medical device companies rely upon distributors to sell their devices rather than developing their own direct sales force. What difference does it make if you are selling to a distributor in Austin, TX or Galway, IRE? If your company is going to use distributors, pick the easier regulatory hurdle first and work your way up the ladder of difficultly while your distributors bring in some cash.

Success in any business is about sales, sales and sales.

Before you even start designing a medical device, you should be talking to potential distributors. Distributors and sales people are one of the best sources of product ideas. If you are a CEO/founder hopeful, you are more likely to succeed if your background is sales and marketing. Engineers can invent 100’s of medical devices and mousetraps (MD&M), but it is rare to find an inventor that can sell—let alone explain the difference between the strategic marketing plan and the advertising plan.

My advice is to start with the strategic marketing plan for Canada and then one or two countries in Europe. If you have trouble identifying distributors for your type of device in these markets, then you are not competent as a sales and marketing person. You need to get help!

If you don’t know where to look for help, you might ask your regulatory expert. Regulatory experts have to research the competitor products in order to identify known risks and typical adverse events. Regulatory experts also need to identify the competing products before they can be certain of a regulatory pathway. Authorized representatives are sometimes quite helpful in identifying distributors too.

My final advice is to save the US Market for last!

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