FDA Regulatory Requirements and Approvals

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IEC 60601-1

The IEC 60601-1 medical device standard is the authoritative document on product safety and the technical requirements of meeting the rigid FDA approval standards.

Medical devices as determined by the FDA are placed into one of three categories of classes, Class I, Class II or Class III.

Class I devices are defined as devices used in non-life sustaining tasks.  This is the least complicated of the 3 classes of devices.  These devices conform to  the "General Controls" type of devices.

Class II devices are also defined as devices used in non-life sustaining situations.  These devices are more complicated and present more risk than Class I.  These devices are subject to more requirements and must meet specific labeling requirements, mandatory performance standards and postmarket surveillance..  These devices must conform to both the "General Controls" and "Special Controls"  type of devices.

Class III devices sustain or support life.  Failure of this device is life threatening.

Class I - General Controls

Class I devices are subject to the least amount of regulatory control. They present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices.

Class I, II and III devices are subject to the "General Controls" listed below.

General controls include:

1. Establishment Registration (use FDA Form 2891) of companies which are required to register under 21 CFR Part 807.20, such as manufacturers, distributors, repackages and relabelers. Foreign establishments, however, are not required to register their establishments with FDA.
2. Medical Device Listing (use FDA Form 2892) with FDA of devices to be marketed.
3. Manufacturing devices in accordance with Good Manufacturing Practices (GMP) in 21 CFR Part 820.
4. Labeling devices in accordance with labeling regulations in 21 CFR Part 801 or 809.
5. Submission of a premarket notification [510(k)] before marketing a device.

Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments.

Class II - Special Controls

 Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls.

A few Class II devices are exempt from the premarket notification.

Special controls may include special labeling requirements, mandatory performance standards and postmarket surveillance.

Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.

Class III - Premarket Approval

Class III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls.

Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.

Premarket approval is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Not all Class III devices require an approved premarket approval application to be marketed. Class III devices which are equivalent to devices legally marketed before May 28, 1976 may be marketed through the premarket notification [510(k)] process until FDA has published a requirement for manufacturers of that generic type of device to submit premarket approval data.

Class III devices which require an approved premarket approval application to be marketed are those:

1. regulated as new drugs prior to May 28, 1976, also called transitional devices.
2. devices found not substantially equivalent to devices marketed prior to May 28, 1976.
3. Class III preamendment devices which, by regulation in 21 CFR, require a premarket approval application.

Examples of Class III devices which require a premarket approval include replacement heart valves, silicone gel-filled breast implants, and implanted cerebella stimulators.

Class III devices which can be marketed with a premarket notification 510(k) are those:

Examples of Class III devices which currently require a premarket notification include implantable pacemaker pulse generators, vascular grafts less than 6mm in length, and endosseous implants (implants that are surgically inserted into the jawbone).