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Act.  In other words, some uses of some devices would be

permitted even before the devices were approved for market-

ing.  In addition, manufacturers would be permitted to make

minor modifications to devices that are undergoing clinical

trials without having to restart the review process with a

new application.  The bill also provides exemptions for

devices that will serve only a tiny patient population and

that probably would not be brought to market if the costs of

the full review process had to be borne.

The Barton-Eshoo Bill directs the secretary of HHS to

publish

notices identifying and adopting applicable na-

tionally or internationally recognized consensus

standards to which a person [a manufacturer] may

self-certify compliance for the purpose of demon-

strating a reasonable assurance that a device is

safe or effective or to determine compliance with

any requirement of this Act.

This provision reserves to the secretary the decision about

which consensus standards to recognize, and a later provi-

sion reserves to the secretary the authority to demand all

data and information considered by the applicant, thereby

maintaining government control.  Even so, if consensus

standards are published, manufacturers will be spared at

least some of the delay now imposed by the FDA.

The bill also directs the secretary to accredit third-

party organizations to review applications for 510(k) devic-

es.  Third-party accreditation would be limited to Class I

and Class II devices (excepting Class II devices that are

designed for implantation or that could have life-threaten-

ing consequences should they fail).  The secretary would

provide manufacturers that choose the third-party route with

a choice between at least two accredited organizations.

The FDA Monopoly Is Preserved

The bills are a step forward in the review of 510(k)

applications, but the FDA retains its powers.  As the Senate

report says,

The provision maintains a strong, continued role

for the FDA in the device approval process. . . .

The FDA alone accredits the pool of qualified

private parties to conduct the reviews. . . .