Unpacking the Means: Assessing the FDA’s Emphasis on Enforcing 510(K) Import Requirements | Epstein Becker & Green


[co-author: Dawn Norman]*

A private equity client recently asked us to assess a rumor that the FDA was on a war footing by enforcing the 510(k) requirement on medical devices from a particular region. Such a government initiative would significantly deter investment in companies that matter. Turns out the agency wasn’t. Recent FDA activities in the region were well below their historical standards.

But the project got us thinking, what does the agency’s huge database of import actions tell us about the agency’s enforcement priorities more generally? There are literally thousands of ways to slice and dice the import dataset to get insights, but we’ve picked just one as an example. We wanted to assess, globally, over the past 20 years, in which therapeutic areas has the FDA most often applied the 510(k) requirement?

The FDA maintains and publishes a database of import inspection activities that includes refusal to import. The database contains a lot of information for each denial, including the importing company’s establishment registration number, name, address, product description, a shipment number, domain clinic in which the product is classified, the industry of the importer and a code representing the reason for rejection. FDA denial. The FDA provides a complete list of these codes and what they represent in a downloadable Excel spreadsheet.

Over the past 22 years reflected in the database, there have been approximately 125,000 device shipment denials.

There is a specific code, 508, which identifies denials based on the absence of a required 510(k). Certainly, the FDA may have several reasons for denying entry. So, I filtered the data on the basis that at least one of these reasons was 508. There have been just over 18,000 such rejections in the last 22 years. We might as well make one for the lack of premarket approvals, but we didn’t combine them because we were concerned it would obscure trends related specifically to the 510(k) requirement.

We decided to present the results in a heat map showing where, in the context of import denials, FDA activity enforcing the 510(k) requirement has been greatest over time and relative to the clinical area.

I find the visualization fascinating in that there are a number of import denials based on not having a 510(k), and large differences by clinical area and time for those denials.

Expected volume of FDA denials

Mechanically, Customers and Border Protection (CBP) uses an automated system to screen input data for entry. If the import contains a medical device, the data will be sent to the FDA and its PREDICT system[1]as shown in Figure 1. The system will query the databases for relevant information such as establishment records, drug lists, marketing approvals, etc. code accuracy, data anomalies in the information transmitted and admissibility history (importer, exporter, manufacturer and final consignee). [2] If accurate data is provided, the entry will pass the system’s automatic re-search and will likely be logged as “Can Continue” by the system. If the entry does not pass the automatic search, it will be reviewed manually by an Entry Examiner, as shown in Figure 2. Therefore, it is important that importers complete the documents correctly so as not to be tricked by the automated system. system. It’s possible that much of what we see is simply the product of incorrect documents that are ultimately settled manually.

Figure 1: Automated Business Environment (ACE) Process

More importantly, if the entry is kicked out of the automated system, to assess whether a 510(k) is needed, inspectors look at the product code the importer declared for the product and search the database of the FDA to see if a 510(k) is necessary. k) is required, then consult the documents provided by the importer to see if a 510(k) for such a product code is identified. This 510(k) simply needs to be associated with the establishment number of the importer’s establishment. So when the automated system refuses entry, the FDA can check if the import documents do not identify any 510(k) when, based on the claimed product code, a 510(k) is required.

In some ways, enforcing import rules in this space is difficult for the FDA because it relies in part on an honor system. Import documents must identify an applicable 510(k) and a list of devices for imported products, if a 510(k) is required. But the import inspector really has little opportunity to assess whether this assertion is valid or not.

It’s not the most elegant or polished analysis, but it’s for importers who reference a product code that requires a 510(k) but haven’t listed it with their establishment. The point is, no one should be caught at the border by the system if they’ve simply checked ahead of time to see if the product code they’re using requires a 510(k). It’s simple to do on the FDA website.

FDA import inspectors have very little visibility into whether or not the claimed 510(k) applies to the product. For example, if a product was changed such that a new 510(k) would be required but was incorrectly documented as an internal letter to file rather than a new 510(k), FDA staff in the ports has little ability to assess this. All they can really check is if in the system the importer has a 510(k) for the product code that the company declared for the imported product.

Unfortunately, dishonest or ignorant importers might just pretend their product matches a product code that doesn’t require 510(k), and inspectors might not notice. Many goods pass through ports, and these inspectors do not have the time or technical knowledge to physically walk through and inspect all products and their instructions for use, and decide on the correct product code. Additionally, inspectors really have no infrastructure or system in place, as already explained, to judge whether the referenced 510(k) is up to date with the current product design.

You might be tempted to assume that people know if a 510(k) is required for their imported product, and dishonest people take steps to avoid getting caught. If the system mostly only catches a few honest people who haven’t realized that a 510(k) is required for a given product code, and doesn’t catch people clever enough (dishonest) to at least fill out the paperwork in a way that passes inspection, one would expect enforcement to be light in volume overall.

While the data can’t tell us how many scammers get away with importing an unapproved product, there are apparently plenty of honest people who apparently haven’t checked whether their product code requires a 510(k). To the credit of the FDA, the system prevents the importation of these products. It’s just surprising to me that so many people haven’t done the basic check, once they find a product code, to determine if a 510(k) is required.


We noticed a high level trend. It appears that the areas on the chart that are significantly low in terms of FDA enforcement levels on this particular 510(k) issue are in vitro diagnostic devices, or IVDs. In the table, this includes chemistry, hematology, immunology, microbiology, pathology and toxicology. Compare the application levels there with general hospital or general surgery.

We wondered why? Granted, with DIVs, many of them are 510(k) exempt, but many are not. Many IVDs are Class I devices that still require a 510(k). Unfortunately, many people think that a Class I product means you don’t need to submit a 510(k) at all. Also, some of the international products could be considered components of IVDs rather than finished IVDs, or they could be placed in categories such as research use only. But honestly, we haven’t offered a satisfying theory as to why IVDs aren’t denied entry more often based on no 510(k) compared to other clinical areas.

Other comparisons

Besides this high-level trend, it is also interesting to simply compare two different clinical fields, such as ophthalmology with orthopedics. Both include many products that require a 510(k), and yet ophthalmic devices tend to have much more difficulty at the borderline with the 510(k) issue.

If you came to this post via LinkedIn or other social media, we’d love to hear your interpretation of this data. Obviously, there are underlying things going on here that we haven’t identified. But overall, we’re surprised that so many importers simply haven’t checked to see if the FDA requires a 510(k) for their product code.

[1] https://www.cbp.gov/sites/default/files/documents/Final%20FDA%20ACE%20FOODS%20Webinar%20Powerpoint.pdf

[2] http://www.aaei.org/wp-content/uploads/2015/12/FDA-Best-Practices-Manual-Update-FINAL-Sept-2015.pdf

*EBG Advisors

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