Recap Of The Required Documentation For Medical Devices For Premarket Notification

Recap of the Required Documentation for Medical Devices For Premarket Notification

The Required Documentation for Medical Devices For Premarket Notification

A premarket notification or 510(k) is a collection of documentation that establishes substantial equivalence to an existing medical device. The FDA does not provide regulatory writers with a 510(k) form to complete but rather guidance documents. The content in these guidance documents helps writers put together a package in a format called a 510(k). Most of the documentation provided in the 510(k) comes from the verification and validation testing. However, some testing might be leveraged from the predicate device.

The 510(k) has a few administrative sections, which include a formal cover letter, a few different FDA forms, a 510(k) summary, a description of the device, and proof of payment. More information on these sections can be found in the FDA guidance document, “Format for Traditional and Abbreviated 510(k)s.” The main sections of a 510(k) are the substantial equivalence, labeling, shelf life and sterilization, biocompatibility, software, electromagnetic compatibility and electrical safety, and performance testing sections. The sections that regulatory writers and design engineers spend the most time developing are the substantial equivalence and the performance testing sections.

Substantial Equivalence Section

Substantial equivalence is the bulk of the argument in a 510(k). The premise is that if a medical device is substantially equivalent to an existing medical device in terms of safety and efficacy, then it is cleared for market. However, to establish substantial equivalency, engineers design the product to be equivalent to the predicate device. In addition, FDA does not typically allow manufacturers to utilize two predicate devices. This section in the 510(k) will compare the new and predicate devices to illustrate the similarities and justify differences. Typically in this section, manufacturers will reference the 510(k) guidance documents and include 510(k) flow charts.

Performance Testing Section

Performance testing is conducted as benchtop testing, animal testing, or human clinical testing. The type of testing required depends on the device’s safety profile. Typically the testing is done using the new device and the predicate device. The predicate acts as a control device. The expectation is that the new device will perform the same way. The protocols for the bench, animal, or clinical testing will have different test cases to evaluate how well the device performs and if safety features perform as expected. Typically the performance testing includes both verification and validation testing. Therefore both user needs and design inputs are tested.

Documents not to submit as part of the 510(k)

When putting together a 510(k), it is important to be transparent with the FDA and submit all relevant documentation. However, an experienced regulatory writer will know what documentation is not needed to be included in the 510(k). Documentation not included in the 510(k) can still be reviewed by the FDA during an audit. Documents like procedures, work instructions, and quality manuals do not need to be included in the 510(k). 

How to submit a 510(k)

Once a 510(k) is completed and the cover letter is signed, then it is ready to be sent to the FDA. Typically, manufacturers choose to submit their FDA as an “eCopy.” What this means is the 510(k) is burned on a CD or USB and organized according to the eCopy guidance. The CD or USB and paper copy of the cover letter are mailed to the FDA’s document control center (DCC). 


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