Page 53 - Biomedical Engineering and Design Handbook Volume 2, Applications

32 MEDICAL DEVICE DESIGN

(2) The Code of Federal Regulations citation for any applicable standard for the device under section
514 of the act or section 358 of the Public Health Service Act.
(3) The assigned Food and Drug Administration number of the approved application for each device
listed that is subject to section 505 or 515 of the act.
(4) The name, registration number, and establishment type of every domestic or foreign device estab-
lishment under joint ownership and control of the owner or operator at which the device is man-
ufactured, repackaged, or relabeled.
(5) Whether the device, as labeled, is intended for distribution to and use by the general public.
(6) Other general information requested on form FDA-2892, i.e.,
(i) If the submission refers to a previously listed device, as in the case of an update, the docu-
ment number from the initial listing document for the device,
(ii) The reason for submission,
(iii) The date on which the reason for submission occurred,
(iv) The date that the form FDA-2892 was completed,
(v) The owner’s or operator’s name and identification number.
(7) Labeling or other descriptive information (e.g., specification sheets or catalogs) adequate to
describe the intended use of a device when the owner or operator is unable to find an appropriate
FDA classification name for the device.
Id. § 807.25, as amended, 69 Fed. Reg. 11,312 (Mar. 10, 2004).

Note that there is no FDA form or required format for this filing. Over time, tools have been
developed, both by FDA and by regulatory personnel, so that 510(k)s look similar. However, it is not an
FDA-regulated format. FDA has published a checklist that many filers actually include in the submission.
The heart of the 510(k) process is to show substantial equivalence. After you submit your 510(k),
FDA reviews it. The statute requires that it be finished in 90 days. FDA has rarely had the resources
to meet this statutory agenda, but had recently come close to 90-day review periods. FDA may send
a letter finding your submission substantially equivalent (SE) or not substantially equivalent (NSE).
An SE letter will contain a 510(k) number for your product which is the letter K followed by two
digits indicating the year and four digits indicating the numerical place in which your 510(k) was
issued in that year.
Note that this is not a legal order, like a PMA letter. FDA has far less authority to place any con-
ditions on a 510(k). It is basically a form letter finding your submission SE.
The heart of this process is substantial equivalence. The statutory algorithm for showing sub-
stantial equivalence to a predicate is

(i) Substantial Equivalence
(1) (A) For purposes of determinations of substantial equivalence under subsection (f) and section
520(l), the term “substantially equivalent” or “substantial equivalence” means, with respect to a
device being compared to a predicate device, that the device has the same intended use as the
predicate device and that the Secretary by order has found that the device—
(i) has the same technological characteristics as the predicate device, or
(ii) (I) has different technological characteristics and the information submitted that the device is
substantially equivalent to the predicate device contains information, including appropriate
clinical or scientific data if deemed necessary by the Secretary or a person accredited under
section 523, that demonstrates that the device is as safe and effective as a legally marketed
device, and (II) does not raise different questions of safety and effectiveness than the predi-
cate device. (B) For purposes of subparagraph (A), the term “different technological charac-
teristics” means, with respect to a device being compared to a predicate device, that there is
a significant change in the materials, design, energy source, or other features of the device
from those of the predicate device.
21 U.S.C. 360c.

This algorithm has allowed science to march on, producing improved technologies for medical
devices without resorting to the PMA process unnecessarily. When one works through the Boolean
algebra, you can see that it results in a standard with remarkable flexibility.