Testing and introduction of new materials - Orthopaedic Biomaterials in Research and Practice - page 390

submitted to support claims of safety must be obtained in facilities oper-
ated in compliance with FDA Good Laboratory Practices regulations.
See the Federal Register 43(247):59986, 1978.) In essence, it contains the
information that will be required later for class III premarket approval,
except for the specific results on safety and efficacy, which will be
obtained from the proposed clinical trial.
If a good case can be made that the proposed trial will operate within
the applicable standards and regulations and will expose the patient vol-
unteers to no foreseeable exceptional risk, the IDE will be granted. The
trial may then proceed under the surveillance of an independent quality
control organization, which is charged with reporting both compliance
to protocol and the results of the trial to its sponsors in a form satisfac-
tory to the FDA. Changes in the protocol, including alterations of treat-
ment indications, treatment procedures, and number of patients, may be
necessary as the trial proceeds. Provisions in the IDE regulations permit
such changes to be made, although frequently with some difficulty, by
amendment of the original application.
release for general use
After completion of the clinical trials, the entire body of information
gathered must be submitted to the FDA for final approval (the so-called
PMA or premarket approval) before the device containing the new mate-
rial passes into general clinical use. The material will be reviewed by an
advisory panel of academic and clinical experts in the field (in this case,
orthopaedics). The advisory panel will recommend approval or disap-
proval, and the FDA will act on this recommendation.
Approval will generally be given if the findings suggest that the mate-
rial in this application meets the conditions of safety and efficacy previ-
ously stated. However, there are a number of caveats to such approval:
1. The approval will only be given for the application that was the
subject of the clinical trial. Other, expanded indications may be
added at a later date through amendments to the original PMA
or possibly through 510(k) applications, but may also require
additional clinical trials. In particular, approval of a material in
one device does not signify blanket approval for other device
applications.
2. The indications and contraindications for use must be agreed to
between the FDA and the manufacturer. In particular, they must
appear in the packaging insert and in advertising material, and
advertised claims must be restricted to agree with them.
3. Some form of long-term follow-up of the original study group may
be required as well as surveillance of patients treated for some
period after initial release (typically 2-4 years). Such a follow-up
may produce additional information on clinical performance and
may require changes in the previously agreed indications and con-
traindications for use.