Page 51 - Biomedical Engineering and Design Handbook Volume 2, Applications

30 MEDICAL DEVICE DESIGN

(v) The methods used in, and the facilities and controls used for, the manufacture, processing, pack-
ing, storage, and, where appropriate, installation of the device, in sufficient detail so that a per-
son generally familiar with current good manufacturing practice can make a knowledgeable
judgment about the quality control used in the manufacture of the device.
(5) Reference to any performance standard under section 514 of the act or the Radiation Control for
Health and Safety Act of 1968 (42 U.S.C. 263b et seq.) in effect or proposed at the time of the sub-
mission and to any voluntary standard that is relevant to any aspect of the safety or effectiveness of
the device and that is known to or that should reasonably be known to the applicant. The applicant
shall—
(i) Provide adequate information to demonstrate how the device meets, or justify any deviation
from, any performance standard established under section 514 of the act or under the Radiation
Control for Health and Safety Act, and
(ii) Explain any deviation from a voluntary standard.
(6) The following technical sections which shall contain data and information in sufficient detail to permit
FDA to determine whether to approve or deny approval of the application:
(i) A section containing results of the nonclinical laboratory studies with the device including
microbiological, toxicological, immunological, biocompatibility, stress, wear, shelf life, and
other laboratory or animal tests as appropriate. Information on nonclinical laboratory studies
shall include a statement that each such study was conducted in compliance with part 58, or, if
the study was not conducted in compliance with such regulations, a brief statement of the reason
for the noncompliance.
(ii) A section containing results of the clinical investigations involving human subjects with the
device including clinical protocols, number of investigators and subjects per investigator, subject
selection and exclusion criteria, study population, study period, safety and effectiveness data,
adverse reactions and complications, patient discontinuation, patient complaints, device failures
and replacements, tabulations of data from all individual subject report forms and copies of such
forms for each subject who died during a clinical investigation or who did not complete the
investigation, results of statistical analyses of the clinical investigations, device failures and
replacements, contraindications and precautions for use of the device, and any other appropriate
information from the clinical investigations. Any investigation conducted under an IDE shall be
identified as such. Information on clinical investigations involving human subjects shall include
the following:
(A) A statement with respect to each study that it either was conducted in compliance with the
institutional review board regulations in part 56, or was not subject to the regulations under
Sec. 56.104 or Sec. 56.105, and that it was conducted in compliance with the informed con-
sent regulations in part 50; or if the study was not conducted in compliance with those reg-
ulations, a brief statement of the reason for the noncompliance.
(B) A statement that each study was conducted in compliance with part 812 or part 813 con-
cerning sponsors of clinical investigations and clinical investigators, or if the study was not
conducted in compliance with those regulations, a brief statement of the reason for the
noncompliance.
(7) For a PMA supported solely by data from one investigation, a justification showing that data and
other information from a single investigator are sufficient to demonstrate the safety and effective-
ness of the device and to ensure reproducibility of test results.
(8)
(i) A bibliography of all published reports not submitted under paragraph (b)(6) of this section,
whether adverse or supportive, known to or that should reasonably be known to the applicant and
that concern the safety or effectiveness of the device.
(ii) An identification, discussion, and analysis of any other data, information, or report relevant to an
evaluation of the safety and effectiveness of the device known to or that should reasonably be
known to the applicant from any source, foreign or domestic, including information derived from
investigations other than those proposed in the application and from commercial marketing expe-
rience.
(iii) Copies of such published reports or unpublished information in the possession of or reasonably
obtainable by the applicant if an FDA advisory committee or FDA requests.
(9) One or more samples of the device and its components, if requested by FDA. If it is impractical to
submit a requested sample of the device, the applicant shall name the location at which FDA may
examine and test one or more devices.
(10) Copies of all proposed labeling for the device. Such labeling may include, e.g., instructions for
installation and any information, literature, or advertising that constitutes labeling under section
201(m) of the act.