The Food and Drug Administration (FDA) has provided various Medical Device Development Tools for members of the medical manufacturing industry, tool developers and Food and Drug Administration staff. The tools are a great resource for those looking for materials pertaining to FDA approval requirements.
The Center for Device and Radiological Health (CDRH) has provided the tools as guidance, and as a voluntary qualification process for medical device development. The Medical Device Development Tool (MDDT) qualification is not intended to replace any current regulations, but is available to offer additional support for a more efficient way of providing the information needed for a proper evaluation.
Although the MDDT is intended only for additional support at the moment, the CDRH is developing a qualification process and intends to consider MDDT a valid tool that can be relied on for assessments and regulatory purposes.
“Qualification decisions will be made public and reflect CDRH’s support for the general use of the MDDT within the specified context of use, not just for a single, specific device submission. The value to the public health will be increased as new MDDTs become widely known and available for use by multiple device developers.”
For more information, read the full article on FDA.gov.