Federal Policies and the Medical Devices Industry Page: 9
This report is part of the collection entitled: Office of Technology Assessment and was provided to UNT Digital Library by the UNT Libraries Government Documents Department.
Extracted Text
The following text was automatically extracted from the image on this page using optical character recognition software:
Ch. 1-Introduction and Summary .9
III preamendments devices of these types could
begin. Instead, FDA has completed classifications
of device types in the medical specialty catego
ries in which most of the device associated deaths
and injuries have been and continue to be re
ported e.g., cardiovascular (pacemakers, heart
valves) and obstetrics-gynecology (intrauterine
devices (IUDs)). Furthermore, in September 1983,
FDA expressed its intention of reviewing evidence
of safety and effectiveness for 13 preamendments
Class III device types that it considers of highest
priority. Documentation of safety and effective
ness of products of these types will be needed for
their continued marketing.
Another of FDA's priorities has been to imple
ment the premarket approval process for post
amendments Class III devices. Guidelines for the
procedures by which investigational Class III
devices may be tested and evidence gathered had
been completed by FDA by 1980.
FDA's premarket approval process has been ap
plied to only a small fraction of the devices mar
keted after 1976. Postamendments devices that are
found substantially equivalent to a device already
on the market are automatically classified and reg
ulated like their preamendments equivalent. By
the end of fiscal year 1981, only about 300 of the
17,000 products submitted for clearance to FDA
after 1976 had been found not substantially
equivalent. Although products that are not sub
stantially equivalent are automatically placed in
Class III, the manufacturer can petition FDA for
reclassification, and some manufacturers have
done this.
No performance standards have yet been de
veloped for Class II devices. In practice, there
fore, Class II devices have been regulated like
Class I devices. In mid 1983, FDA identified 11
priority Class II device types for which it was
starting to develop the first performance stand
ards. There is a consensus among industry and
consumers that although an intermediate class of
devices is advisable, it is impractical for FDA
to formulate performance standards for the
more than 1,000 device types now designated as
Class II.Other examples of how FDA has set priorities
in implementing the Medical Device Amendments
can be cited. In 1980, for example, FDA exempted
30 Class I device types in the General Hospital
and Personal Use category from the requirement
that their manufacturers notify FDA before mar
keting them. The manufacturers of these device
types, which include medical absorbent fibers and
specimen containers not represented to be ster
ile, continue to be subject to FDA registration and
surveillance for conformity with good manufac
turing practices regarding manufacture, packing,
and storage.
Substantial negative effects of the 1976 Medi
cal Device Amendments on the medical devices
industry have not been documented to date. Per
haps this result is not surprising, because major
sections of the law have not been fully imple
mented. Patents on medical devices, one indicator
of innovative activity, have shown the same
trends as before the law, with a higher rate of
awards continuing for more sophisticated devices.
Manufacturers have reported increases in R&D,
sales, and new devices introduced since the Med
ical Device Amendments, and national data bear
out these reports. One third of the manufacturers
responding to a national survey in 1981 had entered
the industry after the amendments, and 80 per
cent were optimistic about business in the field
during the next decade. Surprisingly, however,
almost half of the survey respondents stated that
Federal regulation had been a major problem for
them.
The regulations have been more burdensome
to small manufacturers than to large ones; smaller
manufacturers reported higher regulatory costs
per employee than larger ones. Small establish
ments are particularly important in the medical
devices field: about 70 percent of all establish
ments have fewer than 20 employees, and these
small establishments have historically accounted
for substantial innovation. The law expressed par
ticular concern about small manufacturers by re
quiring that FDA establish an office to provide
them information. Although large manufacturers
in the 1981 survey were much more likely to con
sider producing a Class 111 device, it is noteworthy25-406 0 84 2
Upcoming Pages
Here’s what’s next.
Search Inside
This report can be searched. Note: Results may vary based on the legibility of text within the document.
Tools / Downloads
Get a copy of this page or view the extracted text.
Citing and Sharing
Basic information for referencing this web page. We also provide extended guidance on usage rights, references, copying or embedding.
Reference the current page of this Report.
United States. Congress. Office of Technology Assessment. Federal Policies and the Medical Devices Industry, report, November 1984; [Washington D.C.]. (https://digital.library.unt.edu/ark:/67531/metadc39542/m1/15/: accessed March 29, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.