Page 52 - Biomedical Engineering and Design Handbook Volume 2, Applications

FDA MEDICAL DEVICE REQUIREMENTS 31

(11) An environmental assessment under Sec. 25.20(n) prepared in the applicable format in Sec. 25.40,
unless the action qualifies for exclusion under Sec. 25.30 or Sec. 25.34. If the applicant believes that
the action qualifies for exclusion, the PMA shall under Sec. 25.15(a) and (d) provide information
that establishes to FDA’s satisfaction that the action requested is included within the excluded cate-
gory and meets the criteria for the applicable exclusion.
(12) A financial certification or disclosure statement or both as required by part 54 of this chapter.
(13) Such other information as FDA may request. If necessary, FDA will obtain the concurrence of the
appropriate FDA advisory committee before requesting additional information.
21 C.F.R. § 814.20, as amended, 71 Fed. Reg. 42,048 (July 25, 2006).

This can result in a submission, including the six copies, as large as a refrigerator.

2.9 PREMARKET NOTIFICATION [PMN OR 510(k)]

Unlike a PMA, where there is a requirement of begin safe and effective, there is no statutory stan-
dard of review for Class II and I devices. Rather, one uses the 510(k) process to show substantial
equivalence to a product legally marketed in the past.
This previously marketed product is known as a predicate. A predicate can be either a device
legally marketed before 1976 or a product brought onto the market thereafter through the 510(k)
process. The predicate cannot be an illegal or banned device. A PMA product cannot be used for a
510(k) predicate.
So, the first step in clearing a product through a 510(k) is to locate the proper predicate. This may
involve more than one device. Each of the elements of the algorithm for substantial equivalence must
be found in the devices used as the predicate. Therefore, a predicate is needed for the intended use
and for safety evidence. For example, it is common to create a new device to accomplish an old use,
using new technology. In this case, a predicate for the intended use is necessary. Next, a search for
predicates will have to be made that use some form of your technology if there are safety issues to
be satisfied.
A 510(k) is submitted to FDA containing the following information:
(a) Form FDA-2891 and Form FDA-2891(a) are the approved forms for initially providing the informa-
tion required by the act and for providing annual registration, respectively. The required information
includes the name and street address of the device establishment, including post office code, all trade
names used by the establishment, and the business trading name of the owner or operator of such
establishment.
(b) The owner or operator shall identify the device activities of the establishment such as manufacturing,
repackaging, or distributing devices.
(c) Each owner or operator is required to maintain a listing of all officers, directors, and partners for each
establishment he registers and to furnish this information to the Food and Drug Administration upon
request.
(d) Each owner or operator shall provide the name of an official correspondent who will serve as a point
of contact between the Food and Drug Administration and the establishment for matters relating to
the registration of device establishments and the listing of device products. All future correspondence
relating to registration, including requests for the names of partners, officers, and directors, will be
directed to this official correspondent. In the event no person is designated by the owner or operator,
the owner or operator of the establishment will be the official correspondent.
(e) The designation of an official correspondent does not in any manner affect the liability of the owner
or operator of the establishment or any other individual under section 301(p) or any other provision
of the act.
(f) Form FD-2892 is the approved form for providing the device listing information required by the act.
This required information includes the following:
(1) The identification by classification name and number, proprietary name, and common or usual
name of each device being manufactured, prepared, propagated, compounded, or processed for
commercial distribution that has not been included in any list of devices previously submitted on
form FDA-2892.