Summary
The FDA does not issue recalls quickly, because it is not the FDA's responsibility to issue recalls quickly; that is the manufacturer's responsibility. The FDA generally only issues recalls when the manufacturer fails to do so in a timely manner.
How does the abbreviated approval work?
Device manufacturers may choose to submit an Abbreviated [Approval] 510(k) when:
- a guidance documents exists,
- a special control has been established, or
- FDA has recognized a relevant consensus standard.
[...]
An Abbreviated 510(k) that relies on a guidance document should include a summary report that describes adherence to the relevant guidance document and how the guidance document was used during device development and testing. The summary report should include information regarding the manufacturer's efforts to conform with the guidance document and should outline any deviations.
[...]
In an Abbreviated 510(k) submission, manufacturers elect to provide summary reports on the use of guidance documents and/or special controls, or declarations of conformity to recognized standards, to expedite the review of a submission.
[...]
An Abbreviated 510(k) that relies on a recognized standard must include a Declaration of Conformity to the recognized standard. Under certain conditions, conformance test data are not required to be submitted in the 510(k).
(Source, emphasis added)
In short: A manufacturer of a new medical device can refer to studies, standards and even approved medical devices of another manufacturer and claim the same effectiveness and safety for their own new device (that's based on the same technology) without having to repeat clinical studies. The reasoning behind that is that if someone else proved that X-ray is a valid technology to diagnose bone fractures, the manufacturer of an X-ray device doesn't have to prove the same facts again.
All you have to submit to the FDA is a huge amount of documentation claiming that you (the manufacturer) follow all the guidelines and standards that should result in the production of safe medical devices. The FDA trusts that if you follow all the guidelines, you create safe products. It is possible to modify and fake the documentation in a way that it obscures small deviations on your part.
If you chose not to adhere to the given standards and guidelines (maybe because you want to cut costs and decrease the diameter of an implanted electrode), all you have to do is a risk-benefit-analysis showing that the added risk of this measure does not outweight the benefit. If the electrode breaks due to the decreased diameter, you can get away with claiming coincidental failures or temporary deviations in the manufacturing process for a long time.
What the FDA does not do (and is not qualified to do) is testing the safety and effectiveness of a medical device itself. It solely relies on documentation by the manufacturer to approve a device for the US market.
How are medical devices pulled from the market?
First and foremost, the manufacturer of a faulty medical device is supposed to recall such devices. See the list of medical device recalls. Any respectable manufacturer recalls devices after receiving an unusual high number of incident reports, but this is still a voluntary action most of the time and seldom forced by the FDA (see below).
If a manufacturer fails to recall devices on their own, the FDA has the authority to issue a warning letter, force a recall, and take more severe legal actions. The FDA Enforcement Statistic of the Fiscal Year 2017 lists the following types of inforcements:
| Enforcement Type |
Number |
| Seizures |
3 |
| Injunctions |
12 |
| Warning Letters |
15,318 |
| Recall Events |
2,945 |
| Recalled Products |
9,199 |
| Drug Product Debarments |
5 |
| Food ImportationDebarments |
0 |
As you can see, the number of recall events is only 1/5th of the number of warning letters issued and the statistic doesn't even distinguish between voluntary recalls by the manufacturers and recalls forced by the FDA.
The openFDA API is an interface to query the publicly available FDA database. A query of all mandatory vs. voluntary recalls ever yields:
| Term |
Count |
| Voluntary: Firm Initiated |
18,943 |
| FDA Mandated |
94 |
| Voluntary: FDA Requested |
8 |
(Source; the query used is: https://api.fda.gov/device/enforcement.json?count=voluntary_mandated.exact)
How fast does the FDA respond?
This is where it gets blurry. I haven't found any practical means to compare the date of the first incident report of a product to the issue date of the recall. But realistically we have to assume:
- Incident reports for medical devices are a quite common occurance, since manufacturers and users of such devices are supposed to report any problems with the usage, effectiveness, documentation and marketing of it.
- Single reports do not warrant any action from the FDA. There has to be a significant number of reports or at least a significant trend in numbers to warrant any action from the FDA.
- The FDA mostly relies on the good will of manufacturers to recall their own products and will only take legal actions after the manufacturer failed to react on its own.
When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform FDA of its plans for correction. FDA then checks to ensure that the company’s corrections are adequate.
(Source, emphasis added by me)
This adds another, undefined period of time to the time frame between the first occurance of a fault and the correction or recall.
Why does it take so long?
In the comments the question arised why the FDA takes so long to take actions against unsafe medical devices.
If you look at it from the FDA's perspective, they take actions before any unsafe products can even do harm to people, meaning they do not approve products for the US market if there are doubts about the quality of the product or production process. But all they have to make this assessment is a huge documentation (easily hundrets of pages). Manufacturers who care more about money than safety can fake and manipulate documents to a certain degree to push products on the market or they can simply do sloppy work and not be aware of the risks and faults of their own product.
Once a product is approved, there is quite a lot of trust implied. This trust is hard earned (FDA does have one of the strictest medical device oversights globally) and is equally hard to lose.
If you read a story about a man crippled by a malfunctioning medical device, you feel sorry and maybe enraged. If the FDA gets one incident report, it's no big deal. Medical devices are used to treat or cure patients who are ill or injured to begin with. If one of them dies it's always hard to tell if they wouldn't have died without the device just the same. Who is to blame? Did the device itself malfunction? Was the manual unclear and lead the surgeon or even the patient use the device in an inappropriate way? Did anyone even read the manual? Did someone conciously use the device in an inappropriate way?
Immagine reading that 85% of patients treated with SecretDevice X died immediately during treatment. Sounds severe, right? Now immagine that SecretDevice X is a defibrillator. Without this device probably 98% of patients in the same situation would have died, but no one would connect their deaths to any medical device. That's why it's so difficult to tell from incident reports alone whether a device is unsafe.
