Companies that are strapped for time and cash would do well to understand exactly what the agency wants and avoid unnecessary pitfalls, says Michael Lynch, managing consultant at Intertek.

(Lynch will be presenting a straightforward webinar on Jan. 31, at 2 p.m. Eastern time: “5 Steps to Medical Device Commercialization in the U.S.”)

“FDA is a whole new paradigm for international manufacturers,” Lynch said. Likewise, startups don’t have the institutional knowledge to know the pitfalls that can arise.

“There are plenty of pitfalls in the process,” Lynch adds.

Here are four pitfalls that stick out to Lynch:

1. Using multiple predicates for a 510(k)

Many companies try to use two different products to define the predicate device for a 510(k) submission—one that represents the technology and one that represents the intended use. “FDA had been pretty clear, however, that a single predicate is preferred and it should match both the technology and the intended use,” he says.

2. Going De Novo without understanding the consequences

Lynch also notes that companies with new technology might find the only alternative to a PMA is to use the De Novo pathway, but Lynch says that might not give you the intended result. “If you are first via De Novo, you might have lowered the bar for people following you.” That might be an acceptable risk depending on the circumstance, but companies need to understand it up front.

3. Rushing to market

Lynch also says he sees a lot of companies, particularly startups, in a hurry to get to market. They might submit to FDA, saying the product was developed using design controls, but in reality, they haven’t fully implemented design controls or their quality management system. “Startups don’t want to spend time and money developing systems unless they are sure they will have an approved product to sell. ”

Surprisingly, this isn’t an enormous business risk in the US. “You have to consider that for a Class II 510(k), you might have two to three years before your first FDA audit. The challenge comes in when companies put in the design controls later and then all the documentation is dated after the FDA submission.”

And, if your technology is new and you are submitting a PMA, Lynch advises that those design controls better be in place and fully compliant. Evidence must be included in the submission and an inspection is typically part of the submission review process.

4. International companies not understanding the nuances

For international companies the challenges are different. Many times, these companies have the quality management system in place, but they don’t necessarily understand the deviations that exist between the requirements of ISO 13485 and the U.S. regulations 21 CFR 820, as well as the differences in the approval processes for class II and III devices. “These device makers should spend some time exploring those differences, which is exactly why we developed this webinar.”

FDA requirements for submission of a medical device for commercialization in the U.S. have many facets for manufacturers to consider when developing their products. Companies will save themselves a lot of heartache, time, and money, says Lynch, if they can get it right the first time.

(Lynch will be presenting a webinar on Jan. 31, at 2 p.m. Eastern time: “5 Steps to Medical Device Commercialization in the U.S.”)

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