When does FDA-regulated product development begin?
All medical devices intended for use in diagnosing or treating humans are required by the FDA to be developed under Quality System Regulations (QSR) that include the concept of “Design Controls”.
Design control regulations must be followed by all companies (regardless of size or stage of corporate development), starting from the initial development of product features and performance requirements, and continued through the transfer from engineering to manufacturing.
For more information on early-stage documentation requirements, see Customer Needs Assessment.
The basic idea of a Design Control system:
Commit at the beginning of the development process to what you are going to create, why you are designing it this way (customer needs), and then apply a standardized process for accepting and documenting changes along the way. Finally, you will demonstrate that you accomplished what you set out to do.
Documentation of compliance with this process is recorded in the company’s Design History File (DHF), which describes in detail the origin of the device design, all formally approved changes that take place leading up to final product design, and performance requirements that would be embodied in any application for clearance or approval to market the device.
It is not inexpensive to establish an FDA-compliant documentation system, especially if you require the assistance of consultants. It may also seem like a lot of work to create and follow such a system, but it is simply a necessary component of “doing business” in the medical products sector.
On the positive side, these quality controls not only protect patients from poorly designed devices, but also protect a company from increased liability associated with poor designs. Therefore, compliance with these regulations generally will save time and money in the long run and also establishes a history that becomes of great value to any potential acquirer of the technology.
Note: Design controls are also required for development of medical devices elsewhere in the world. For instance, CE Mark for clearance in Europe requires following ISO 13485 (Design Control standards).
Design Controls may be required during prototype development ...
Design Control documentation would be necessary if the prototype is destined to be tested on humans, or even if the prototype would ever be used to collect bench data that would subsequently be included in a regulatory submission to demonstrate safety and/or efficacy of the device.
In general, if a regulatory reviewer is not confident the prototype device (that was used to generate submitted data) is equivalent to the device for which approval is being sought, the submission may be rejected.
NOTE: In the event that prototype development work is being conducted within a university under a company-sponsored research agreement, it would be advisable for the university principal investigator to seek guidance from the company early in such a relationship regarding the level of design documentation the sponsor believes would be required in order to “bridge” successfully into the company’s DHF.
Remember, this would not become an issue unless there was an intention for the university-developed prototype to generate data (bench or pre-clinical) that would subsequently be presented within a submission to the FDA seeking clearance or approval of a later generation of the device (i.e., following additional development by the sponsor outside the university). For more discussion related to university prototyping of medical devices, go to Medical Device Prototypes.
For a review of QSR and Design Controls utilizing helpful examples, visit Stanford University’s Introduction to the Regulation of Medical Devices.
For definitive guidance on these regulations, visit this FDA website.