USFDA (United States Food and Drug Administration) regulates medical devices in the USA. According to USFDA, medical devices are classified as class I, II and III and can be registered using different pathways i.e.; Premarket approval application (PMA), Premarket notification 510 k, De Novo, Humanitarian device exemption (HDE), Investigational Device Exemption (IDE).
This blog will discuss a recently released draft guidance for 510k submission for “best practices for selecting a predicate device”. Almost all Class II and certain Class I devices require a 510(k) clearance. As per the 510k requirement, a device gets cleared if it is substantially equivalent to a predicate device. To guide in selecting a predicate device, the FDA released a guidance document on July 28, 2014, “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]”, in which examples are provided for selecting a predicate device. The FDA has identified four best practices for selecting an appropriate predicate device in this guidance.
This guidance is recommended to be used in conjunction with “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” and other relevant guidance.
Let’s look at the best practices for selecting a predicate device:
FDA recommends four (4) best practices when selecting a predicate device to support a 510(k) submission. This guidance aims to improve the predictability, consistency, and transparency of the 510(k) premarket review process. The best practices are as follows:
- Predicate devices cleared using well-established methods
- Predicate devices meet or exceed expected safety and performance
- Predicate devices without unmitigated use-related or design-related safety issues
- Predicate devices without an associated design-related recall
1. Predicate devices cleared using well-established methods
FDA recommends that, once the predicates are identified, the submitter should select the predicate device that was cleared using FDA’s currently recognised consensus standard or FDA guidance documents. This will ensure that the subject device is evaluated using the most recent scientific techniques available and will encourage the growth of safer and more effective medical devices.
2. Predicate devices meet or exceed expected safety and performance
FDA recommends that the submitter select a valid predicate by considering the safety and effectiveness of the device. The submitter should search the FDA database for adverse events, malfunctions, or deaths reported against the predicate device on the following websites:
- Manufacturer and User Facility Device Experience (MAUDE) database,
- Medical Device Reporting (MDR) database and
- MedSun Reports Database
3. Predicate devices without unmitigated use-related or design-related safety issues
Once the valid predicate is identified, the submitter should consider emerging signals or safety communications while selecting the predicate device. These signals and communications can provide information about the device's use or design-related issues, and they are available on the “Medical Device Safety” and “CBER Safety and Availability (Biologics)” websites. FDA recommends that the submitter select a valid predicate not associated with emerging signals or safety communications related to unmitigated use- related or design-related safety issues whenever possible.
4. Predicate devices without an associated design-related recall
Recall can occur due to design, manufacturing, or labelling defects. Once the submitter identifies valid predicates, the FDA recommends searching for the Medical Device Recall Database to assess recall associated valid predicate devices and select the predicate device without design-related recall.
Additionally, to improve the transparency of predicate devices, the FDA recommends that the submitter include an explanation for the predicate device by using the FDA’s best practices for selecting a predicate device guidance. Suppose the submitter did not find a valid predicate device consistent with best practice guidance. In that case, the statement should be included in the 510k summary, indicating that a valid predicate consistent with the best practices was unavailable. The submitter should use performance data to describe that performance testing was conducted to address the predicate device’s known safety or effectiveness concerns to support the submission.
Let’s look at examples of how to select a predicate device and explain the selected predicate device.
The submitter identifies four valid predicate devices with the same intended use. Differences in technological characteristics do not raise different questions about safety and effectiveness.
In example 1, predicate 4 is cleared according to best practices requirement and does not have any design-related issues, as well as the frequency of adverse events is low even after a long time in the market, so it can be considered an appropriate predicate device.
Example 2
The submitter found only one valid predicate device with the same intended use, and the difference in technological characteristics does not raise different questions about safety and effectiveness.
Example 3
The submitter found two valid predicate devices with the same intended use. Differences in technological characteristics do not raise different questions about safety and effectiveness.
In example 3, both valid predicates cleared according to best practices, but predicate 1 has a longer duration in the market, a low frequency of adverse events, and no design-related recall. So, it can be considered that predicate 1 has a well-established safety profile and is selected for the predicate device.
Now that you know about the FDA’s expectations, you should be able to identify the appropriate predicate device. We will keep you updated on any upcoming regulatory requirements. Meanwhile, check out our services to help you gain access to the regulated markets.
