After the FDA has accepted a manufacturer’s premarket notification, if the agency requests additional information by telephone, fax, or letter, the manufacturer should either submit it within 30 days, or request an extension and state the time needed. When respond­ing, identify the additional information with your company name and 510(k) number. If you submitted a […]

A premarket notification must include either a summary of the 510(k) safety and effec­tiveness information upon which the substantial-equivalence determination is based or a statement that this information will be made available by the 510(k) applicant to any person within 30 days of a written request.129,130 In order to comply with this requirement, manu­facturers should […]

If the device is to be marketed as part of a convenience kit, the FDA guidance regarding kits should be consulted.1 28 A critical part of that guidance calls for certification by the applicant that the components of the kits have already cleared FDA. If the sterile kit con­tains finished sterile examination gloves, the notification […]

Submissions for devices that are labeled sterile must cite their sterilization method, as well as the method used to validate the sterilization cycle. The notification does not, how­ever, have to include actual validation data. The device’s sterility assurance level (SAL) that the manufacturer intends to meet must be included. Note that an SAL of 106 […]

Applications for computerized devices must follow the appropriate CDRH guidance.124 Test data must support all performance and safety claims under routine and limited conditions. Most laser and light-based devices have some element of software control. The FDA published the guidance on May 11, 2005 for software controlled devices: “Guidance for the content of premarket submissions […]

Submissions for devices that directly contact the body—for example, gloves and condoms—must include a description of the characteristics of their materials. This descrip­tion should compare the device to its predicate in sufficient detail to determine biocompat­ibility, as well as the kind of tests needed to determine biocompatibility. Any material differences between the device to be […]

Performance data are often needed to help demonstrate that the proposed device is as safe and effective as the predicate device. These data may include results from engineering, bench, design verification, human factors, animal, or clinical studies. Tests should be conducted in a manner as similar as possible to how the device will be used […]

The 510(k) notification should include a physical description of the new device, together with an explanation of its intended use, principles of operation, power source, composition, and other information necessary to understand the device. If the notification is for an acces­sory, it should describe a typical device with which the accessory will be used. All […]

Before claiming substantial equivalence to a Class III preamendment device, the manu­facturer should determine whether a PMA is required for that generic type of device and, thus, for their product. If no PMA is required, the 510(k) submission must still have a spe­cial added certification statement.122,123