Consumers may find change in the design of medical device

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Consumers may find significant change in the design of medical device that they have used, for the following reasons: 

A. CHANGES TO THE DEVICE OR THE MANUFACTURING PROCESS

Under the new law, certain developmental changes to the investigational device,

including manufacturing changes, are eligible for implementation during the course of the

clinical investigation without prior FDA approval. Modifications that constitute a

significant change in design or basic principles of operation, or that were not made in

response to information gathered during the course of an investigation, however, may not

be made without prior approval of an IDE supplement. In the guidance document

entitled, “Deciding When to Submit a 510(k) for a Change to an Existing Device,”2 the

agency identified generic types of device and manufacturing modifications. Although this

guidance applies to modifications of marketed devices, the types of changes identified are

also applicable to investigational devices. These include changes to the control

mechanism, principle of operation, energy type, environmental specifications,

performance specifications, ergonomics of patient-user interface, dimensional

specifications, software or firmware, packaging or expiration dating, sterilization, and the

manufacturing process (including the manufacturing site).

In the preamble of proposed IDE Modification regulation, FDA stated that all changes to

the basic principles of operation of a device would be considered significant changes and

solicited comments on this premise. No comments were received. Therefore, in the final

rule, FDA stated that all changes to the basic principles of operation of a device should be

submitted in an IDE supplement for prior approval.

For the remaining types of device and manufacturing changes listed above, the changes

can range from minor to significant, depending upon the particular device, the type of

modification, and the extent of the modification. According to the statute, it is the

sponsor’s responsibility to determine if a change made to the device or the manufacturing

process would be considered a significant change requiring prior agency approval. 

This guidance may be found at https://www.fda.gov