A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.
Any medical device approved by the FDA Center for Devices and Radiological Health is classified as either Class I, II, or III
Premarket Notification FDA 510(k)
A 510k submission is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.
Manufacturers who want to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a FDA 510k to FDA unless the device is exempt from FDA 510k requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Premarket Notification 510ks may be filed to the FDA in one of three formats: traditional, special, or abbreviated. The Traditional 510(k) Program can be used under any circumstance to seek marketing authorization for a device through the 510(k) Program.
FDA recommends a 510(k) submission to include the following 20 sections, but all sections shall not be applicable to all devices.
- Section 1.0 – Medical Device User Fee Cover Sheet (Form FDA 3601)
- Section 2.0 – CDRH Premarket Review Submission Cover Sheet
- Section 3.0 – 510(k) Cover Letter
- Section 4.0 – Indications for Use Statement
- Section 5.0 – 510(k) Summary
- Section 6.0 – Truthful and Accuracy Statement
- Section 7.0 – Class III Summary and Certification
- Section 8.0 – Financial Certification or Disclosure Statement
- Section 9.0 – Declarations of Conformity and Summary Reports
- Section 10.0 – Executive Summary
- Section 11.0 – Device Description
- Section 12.0 – Substantial Equivalence Discussion
- Section 13.0 – Proposed Labelling
- Section 14.0 – Sterilization and Shelf Life
- Section 15.0 – Biocompatibility
- Section 16.0 – Software
- Section 17.0 – Electromagnetic Compatibility and Electrical Safety
- Section 18.0 – Performance Testing – Bench
- Section 19.0 – Performance Testing – Animal
- Section 20.0 – Performance Testing – Clinical
Depending on whether the proposed device is an active device, a non-active device, or a software device and the level of risks associated with the device, the documents required to prove the safety and efficacy of the device in the 510(k) submission will have different requirements.
Non-active Medical Device
Devices that do not use any external source of energy other than the human body and gravity to function are called non-active devices. Non-active devices that come under the 510(k) scope can range from examination gloves to orthopedic implants.
The amount of documentation required for 510(k) submission of non-active devices depends on the risk it poses and the tests that need to be performed to prove the safety and efficacy of the device.
For example, a non-sterile device with minimal body contact will require much less documentation than a sterile implantable device.
Sections 16 and 17 mentioned above will not be applicable in the case of a non-active medical device.
Active Medical Device
Active Medical Devices are devices that use electrical energy to achieve their intended purpose.
For electrically powered medical devices and medical devices with electrical or electronic functions, evidence must be provided to prove that the medical device is safe and performs as intended in the environments of use. This evidence includes:
- EMC Information for Premarket Submissions
- EMC-Related Device Characteristics and Intended Use Environments
- Assessment of Medical Device Risks
- Consensus Standards (For both Non-implantable Medical Devices and Active Implantable Medical Devices
(AIMDs))
- Essential Performance and Immunity Pass/Fail Criteria
- Medical Device Configuration and Functions Tested
- Results of EMC Testing
- Allowances
- Deviations
- Modifications
- Common Electromagnetic (EM) Emitters
- Labeling
Software Medical Devices
Software medical devices are medical devices that contain one or more software components, parts, or accessories, or are composed solely of software.
The documentation recommended for software medical devices in a premarket submission generally depends on the device’s Level of Concern. As the level of concern goes high, more documentation will be needed to prove the safety and efficacy of the device.
