Most medical devices sold in the United States today are cleared for commercial distribution or marketing by premarket notification (Class II). However, most Class I devices and some Class II devices are exempt43,44 from the premarket notification and/or good manufacturing practices regulation. The Federal Food, Drug, and Cosmetic Act requires device manufacturers to submit a premarket notification to FDA if they intend to introduce a device into commercial distribution for the first time, or to introduce—or reintroduce—a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such a change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use of the device.
The 510(k) submission identifies characteristics of the new or modified medical device as compared to a medical device with similar intended use, currently legally marketed in the United States. The currently legally marketed device is referred to as the “predicate” device.
The information required in a 510(k) submission is defined in 21 CFR §807.87 and includes the following elements: [5]
• Name and address of manufacturing/packaging/sterilization facilities, Registration number of each manufacturing facility
• Action taken to comply with the requirements of the Special Controls
• Proposed labels, labeling, and advertisements to describe the device, its intended use, and the directions for its use
• 510(k) summary or a 510(k) statement.
• For Class III medical device, a Class III certification and a Class III summary
• Photographs of the device, Engineering drawings of the device
• Identification of the marketed device (s) to which equivalence is claimed including labeling and description of the medical device
• Statement of similarities and/or differences with marketed device(s)
• Data to show consequences and effects of a modified device, performance data (bench, animal, clinical)
• Sterilization information (as applicable)
• Software development, verification, and validation information
• Hardware design and development information
• Information requested in specific guidance documents (as applicable)
• Kit Certification Statement (for a510(k) submission with kit components only)
• Truthful and Accurate Statement
Additional information may also be included in a 510(k) application. For example, contraindications such as skin conditions (for light-based devices) and situations where the device should not be used; warnings describing the significant safety risks from using the device for intended or unintended use; anticipated adverse effects (undesirable side effects) from the use of the device and precautions such as general situations where the use of the device can result in a hazardous condition during the treatment procedure or can cause harm to the treating clinician, patient, or other bystanders in the room (for laser devices).
Depending on the complexity of the new or modified medical device, the FDA Review of a 510(k) submission takes between 60 and 90+ days. The more complex the changes or comparison required to support the safety and effectiveness of the new or modified medical device, the longer will be the FDA review process.
A Traditional 510(k) submission45,46 must include the required elements identified in 21 CFR §807.87. CDRH recommends that device sponsors follow the Traditional 510(k) format provided in their guidance document.47 The 510(k) Screening Checklist48,49 should be used to assure the 510(k) is complete. It is helpful to attach the 510(k) screening checklist to the submission after the table of contents. It should include page numbers where each of the elements in the 510(k) can be found.