Page 50 - Biomedical Engineering and Design Handbook Volume 2, Applications

FDA MEDICAL DEVICE REQUIREMENTS 29

you label it for a specific use in treating a disease state, you can move it into a different range of risk.
This may make it a Class III device, requiring a PMA. This is true even if the identical hardware is
on sale under different labeling in Class II.
A PMA submission is a complex procedure, both for FDA and the industry. The regulatory require-
ments include
(1) The name and address of the applicant.
(2) A table of contents that specifies the volume and page number for each item referred to in the table.
A PMA shall include separate sections on nonclinical laboratory studies and on clinical investiga-
tions involving human subjects. A PMA shall be submitted in six copies each bound in one or more
numbered volumes of reasonable size. The applicant shall include information that it believes to be
trade secret or confidential commercial or financial information in all copies of the PMA and iden-
tify in at least one copy the information that it believes to be trade secret or confidential commercial
or financial information.
(3) A summary in sufficient detail that the reader may gain a general understanding of the data and
information in the application. The summary shall contain the following information:
(i) Indications for use. A general description of the disease or condition the device will diagnose,
treat, prevent, cure, or mitigate, including a description of the patient population for which the
device is intended.
(ii) Device description. An explanation of how the device functions, the basic scientific concepts that
form the basis for the device, and the significant physical and performance characteristics of the
device. A brief description of the manufacturing process should be included if it will signifi-
cantly enhance the reader’s understanding of the device. The generic name of the device as well
as any proprietary name or trade name should be included.
(iii) Alternative practices and procedures. A description of existing alternative practices or proce-
dures for diagnosing, treating, preventing, curing, or mitigating the disease or condition for
which the device is intended.
(iv) Marketing history. A brief description of the foreign and U.S. marketing history, if any, of the
device, including a list of all countries in which the device has been marketed and a list of all
countries in which the device has been withdrawn from marketing for any reason related to the
safety or effectiveness of the device. The description shall include the history of the marketing
of the device by the applicant and, if known, the history of the marketing of the device by any
other person.
(v) Summary of studies. An abstract of any information or report described in the PMA under para-
graph (b)(8)(ii) of this section and a summary of the results of technical data submitted under
paragraph (b)(6) of this section. Such summary shall include a description of the objective of the
study, a description of the experimental design of the study, a brief description of how the data
were collected and analyzed, and a brief description of the results, whether positive, negative, or
inconclusive. This section shall include the following:
(A) A summary of the nonclinical laboratory studies submitted in the application;
(B) A summary of the clinical investigations involving human subjects submitted in the appli-
cation including a discussion of subject selection and exclusion criteria, study population,
study period, safety and effectiveness data, adverse reactions and complications, patient dis-
continuation, patient complaints, device failures and replacements, results of statistical
analyses of the clinical investigations, contraindications and precautions for use of the device,
and other information from the clinical investigations as appropriate (any investigation con-
ducted under an IDE shall be identified as such).
(vi) Conclusions drawn from the studies. A discussion demonstrating that the data and information
in the application constitute valid scientific evidence within the meaning of Sec. 860.7 and pro-
vide reasonable assurance that the device is safe and effective for its intended use. A concluding
discussion shall present benefit and risk considerations related to the device including a discus-
sion of any adverse effects of the device on health and any proposed additional studies or sur-
veillance the applicant intends to conduct following approval of the PMA.
(4) A complete description of:
(i) The device, including pictorial representations;
(ii) Each of the functional components or ingredients of the device if the device consists of more
than one physical component or ingredient;
(iii) The properties of the device relevant to the diagnosis, treatment, prevention, cure, or mitigation
of a disease or condition;
(iv) The principles of operation of the device; and