Never is it too soon to contemplate the regulatory strategy of a new medical device technology. Several considerations should be considered early in the strategic development timeline:
- Has a predicate device been identified?
When a predicate device can be identified in the FDA database, then it is likely the new technology can be positioned as a Class I or II device. A Class I is exempt from the 510(k) process; a Class II requires a 510(k) pre-market approval.
- What is the level of safety risk to the patient?
New technology may present a higher safety risk than a similar Class I or II device, or possibly the new technology has progressed beyond its potential predicate device (i.e. an energy source for treatment has been added to a former diagnostic device). Then approval as a Class III must be considered.
- How will the proposed labeling impact the classification?
Whether a device is classified as a Class I or Class II may depend on the labeling and Indications for Use (IFU). For example, support stockings labeled for “general use” will be a Class I device. If the stockings are labeled as “prevents the pooling of blood,” then a submission for marketing clearance will be required.
- Have you defined the risks associated with the new technology?
Potential risks should be identified and a risk mitigation strategy developed. Even obvious risks need to be identified and their mitigation detailed. The FDA wants to know that the manufacturer considered the risk implications of the device.
- Is the end-user a patient under supervision of a healthcare professional, or will the technology be marketed directly to consumers?
Again, based on the risk assessment, a medical device may present risks which need to be mitigated by the judgment of a healthcare professional. A knee brace designed for support immediately following knee surgery will be available from the healthcare provider and used under professional direction.
Addressing these questions early in the development of the new technology will facilitate a quicker path to approval with a smaller investment of resources.