1.2. Establish Product Description/Specifications/Labeling
A formal description of the proposed product and design requirements based on customer requirements determined from a variety of sources including customer feedback, formal or informal customer surveys, physician feedback, peer-reviewed literature, and medical meetings, presentations and abstracts, and issues identified with previous versions of the device. The Product Description/Definition should establish the initial intended use and indications for use of the device.
The general purpose of a product, which is the objective intent of the persons legally responsible for labeling of a product (or their representatives).
User Needs and Use Case documents additional inputs to ensure that the requirements for the device to meet its intended use and the needs of the customer, user, and patient have been identified. Input considerations may include performance characteristics, product specifications (including tolerances and precision requirements), product features and benefits, proposed indication(s) for use, product indication(s) and contraindications, safety and reliability requirements, environmental requirements and limitations, accessories, interfacing/use with other devices, device serviceability, labeling, applicable national and/or international standards, and regulatory requirements. User Needs and Use Cases are used as an input into the Product Specification.
Claims are part of marketing and advertising of the product which must be correctly describing the device's intended purpose, safety and performance. Claims must not be misleading and must be within scope of the device’s cleared indications for use.
A specific definition of the labeling requirements for product labels, the instructions for use, and any marketing literature required for the design. An assessment of the compliance of the labeling with applicable regulatory requirements, identification of the costs and lead times for procuring the labeling should be performed. The applicable requirements for Unique Device Identification (UDI) must be established at this stage.