Regulatory Challenges in Biomaterials: Focus on Medical Devices - Biomaterials Science: An Integrated Clinical and Engineering Approach - page 241

TABlE 10.2
Critical Steps in Medical Device Development

Stages Comments

Initial Stage
Familiarize oneself with applicable
regulations, including requirements of
Design Controls.

As discussed on the FDA Device Advice web
page, Design Control requirements begin at
the initial stages of device development. You
cannot go back later!

Preclinical Stages
Establish an animal model to evaluate
biocompatibility and device functioning.

Animal model should be scientifically
supported based on device design. Good
laboratory practices requirements apply.

Meet with FDA to discuss biocompatibility
testing and device design.

The types of biocompatibility tests rather than
detailed data would be discussed.

Submit pre-IDE. Provides opportunity for comments.

Submit IDE for FDA review. Local IRB submission may precede this.

Submit study application to local IRB. Studies in U.S. require both IRB and IDE

approval.

Initial Clinical Stages (Phase 1)
Conduct initial phase of human study and
analyze data.

Clinical data would be submitted at least yearly
in IDE annual progress report.

Modify device and clinical protocol as
appropriate.

Consider outcomes of feasibility phase in future
plans.

Later Clinical Stages (Phases 2 and 3)
Submit IDE supplement to FDA for next
phase of clinical testing (two or more
phases may be necessary).

Discussion with FDA advised, particularly if
device is re-designed.

Obtain IRB approval as necessary. More than one IRB approval may be needed,

depending on institutions involved.

Meet with FDA for pre-PMA submission
meeting.

Provides opportunity to discuss format and
content of PMA.

Submit PMA to FDA for review of
marketing application.

Database will have been closed and audited
prior to PMA submission.

Post Marketing Study (Phase 4)
If required as a condition of PMA approval. A post-approval study requirement is
dependent upon many factors.
Reprinted with permission from IOP Publishing Ltd.
Courtesy of Saviola, J. 2005. The FDA role in medical devices clinical studies of human subjects.
J Neural Eng 2: S1-S4.

intimately tied to regulatory requirements, including materials being used,
animal testing, and finally, in some cases, clinical trials.
Simply stated, a clinical trial is a research performed on human subjects. This
research is a scientifically and ethically controlled experiment performed on
a limited population that intends to statistically represent the real population