This article explains how to create a template for 510k submission device description (i.e., Section 11). The template addresses each of the requirements of a device description in the FDA refusal to accept (RTA) guidance document. The template also serves as a summary technical document (STED) for submission to a Notified Body for CE Marking.
You would think that it’s really hard to screw up the device description, but the FDA screening reviewer is completing a new refusal to accept (RTA) checklist (effective October 1, 2015). That checklist has specific requirements for a device description. If you copy the device description from your draft IFU, then you will probably receive an RTA letter on Day 15 of the RTA screening process. The review “clock” is reset to zero, and you have to revise your device description and re-submit.
There are four specific requirements (questions 9-12) in section “B” of the RTA checklist which is titled “Device Description.” In addition to this, there are similar requirements for inclusion in a device description for technical file and design dossier submissions to Notified Bodies. Rather than creating two different device description documents, I prefer to create a template that addresses each of the regulatory requirements in a single controlled document. Therefore, I created a template for the 510k submission device description with the following headings for Section 11 of the 510k submission:
- Product or trade name
- General description—including intended purpose. The general description must be consistent with the device description in the labeling, and this section of the document is intended to address section 10 of the refusal to accept (RTA) checklist.
- A list and description of each device for which a 510(k) clearance is requested in the submission. The list may refer to models, part numbers, various sizes, etc. This section of the document is intended to address section 11c of the refusal to accept (RTA) checklist. It may be helpful to combine this section with section 3 of the template providing a table with UDI device identifier for each product listed.
- UDI device identifier(s)—if available.
- Intended patient population, medical condition to be diagnosed and/or treated and other considerations such as patient selection criteria.
- Principles of operation of the device. This section of the document is intended to address section 11a of the refusal to accept (RTA) checklist.
- A description of proposed conditions of use, such as surgical technique for implants; anatomical location of use; user interface; how the device interacts with other devices; and/or how the device interacts with the patient. This section of the document is intended to address section 11b of the refusal to accept (RTA) checklist.
- Risk class and applicable classification rule according to Annex VII (proposed EU regulations) or Annex IX (MDD). For this section I will cross-reference to a controlled document that includes the complete classification rationale, while this section only includes the classification and the applicable rule(s).
- Explanation of novel features (be careful, this is a regulatory document and not a marketing document).
- Description of components, accessories, other medical devices and other products that are not medical devices, which are intended to be used in combination with the device. Each component/accessory that was part of a previous submission should be identified by the 510k number. Any component(s)/accessory(s) that have not received prior clearance should also be identified. Sometimes a side-by-side table for USA and EU markets is needed for accessories where different accessories are used in different markets. This section of the document is intended to address section 12a, b and c of the refusal to accept (RTA) checklist.
- Description or complete list of the various configurations/variants of the device that will be available
- General description of the key functional elements, formulation, composition, and functionality—including labelled pictorial representations (e.g. diagrams, photographs, and drawings)
- Raw materials incorporated into key functional elements and those making direct contact with the human body or indirect contact with the body
- Technical Specifications of the device and any variants and accessories that would typically appear in the product specification made available to the user, e.g., in brochures, catalogues and the like.
- Representative engineering drawing(s), schematics, illustrations, photos and/or figures of the device. This section of the document is intended to address section 11d of the refusal to accept (RTA) checklist.
- Reference to similar and previous generations of the device. It is important to make sure these devices are included in the clinical evaluation report and if you are submitting a 510k submission you want to make sure that any devices are registered and listed with the US FDA in the same product category. For a device with multiple predicates, it may be necessary to create a table that organizes the “similar” devices by intended use and technological characteristics.
- Requirements specific to special controls guidance document. This section of the template is intended to address section 9 of the refusal to accept (RTA) checklist.
The last section of the device description STED is for any unique requirements specific to the special controls guidance document for the product classification I am working on. However, most of the requirements for a device description are met by the previous items in my outline. Therefore, I create a table that outlines each of the requirements of the special controls guidance document and I provide a cross reference to the section of the outline that includes this requirement. If there are requirements not covered elsewhere in the document, I address the requirement in the table itself. If there is no special controls guidance document, then I state that no special controls guidance document exists for the product.