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said that the FDA staff reviewers "sent back 510(k)s with so

many trivial, unimportant questions that they eventually

became the same as a PMA."30  In an apparent acceptance of

reality, the SMDA of 1990 formally altered the 510(k) pro-

cess from notification to an approval process and augmented

the types and quantities of required data.

Approval Rates for Medical Devices

Table 1 shows the number of submissions for FDA approv-

al of medical devices and the number of approvals each year

from 1989 through mid-1995.  As can be seen, the number of

submissions was highest in 1989, probably because of manu-

facturers' desires to avoid the new requirements expected

with the passage of the SMDA in 1990.  Since then the number

of 510(k) submissions has remained constant at about 6,000

per year.  PMAs have fallen from more than 70 per year to

the 40s, and PMA Supplementals have fallen from about 600 to

about 400.

Approvals per year of 510(k)s have remained nearly

constant, and approvals of PMAs and PMA Supplementals have

fallen.  According to a 1995 GAO report, the FDA has ap-

proved 73 percent of the 40,950 510(k) applications received

during 1989 through May 1995 and disapproved 2 percent.  As

Table 1

Submissions and Approvals for Medical Devices

________________________________________________________________________

510(k)s

PMAs

PMA Supplementals

___________________

___________________

___________________

Year

Total

Approved  Total

Approved  Total

Approved

_________________________________________________________________________

1989

7,023

5,258

84

45

804

640

1990

5,835

4,633

77

36

660

557

1991

5,835

4,513

72

21

595

493

1992

6,533

4,888

66

21

605

474

1993

6,306

4,654

40

7

394

311

1994

6,446

4,342

43

3

372

269

1995

3,033

1,429

19

0

210

78

_________________________________________________________________________

Source: "Medical Devices: FDA Review Time," GAO/PEMD-96-2, October

1995, p. 27.