32

''device. The cross checking of required, submitted information should make it possible to remove many devices before

they cause injury.

Another new power given the FDA is that if after court adjudication the Secretary's order is upheld then the manufacturer must recall all of the defective devices sold.

Failure to do so is punishable under the penalties provisions of the Act.

PART IX

Conclusion

Both bills suggest viable alternatives to todays regulation of the device industry. The pre-clearance method would definitely create a safer and more effective mechanical device. Its drawbacks are that it does not confront the problems created by the untrained user of the device, and also it does not explore what effects pre-clearance would have on the device manufacturer, innovation in the device field, or the extra need for manpower in the FDA to examine and test all the device applications.

H.R. 10061

proceeds at a more cautious pace. Its major drawback is that there would be no possibility of pre-clearance for at least two more years. Its major advantages are that it would implement long range programs to

33

educate the user of the device, and the testing of the devices before use on the patient.

This education program coupled with pre-clearance of the device would probably give the patient his utmost protection. Attached to these two principles must be the recall idea of H.R. 10061_so that all defective devices can eventually

be removed from the market.

These reforms are available, but the historical cycle

of the Congress indicates that probably nothing will be done
about the problem until large groups of people are injured
or killed by defective medical devices within a short period
of time. As long as the thousands of victims that are in-
Jured or killed because of defective medical devices are in
different hospitals in different cities which are spread
apart by time and different means of information, the public
will not notice the danger, and this will permit Congress to
avoid confronting the danger.

But even if no crisis ever occurs, how can Congress justify its laxity on device regulation? What arguments can anyone have against requiring device manufacturers to register their name and place of establishment? Why should not the public expect device manufacturers to operate under good manufacturing practices, or why should not the FDA in the interest of public health be permitted to inspect the records, and investigational reports of the device manufacturer?

Yet, Congress stands and waits. For what? Another tragedy?

1.

2.

FOOTNOTES

21 U.S.0. $321(g)(1); Federal Food, Drug, and Cosmetic

Act 21 201 (g)(1).

21 U.S.C. $321 (h); Federal Food, Drug, and Cosmetic Act 21 $201 (h).

3. 21 U.S.C. $321(g)(1)(D); Federal Food, Drug, and Cosmetic

Act 21 201 (g)(1)(D).

4.

5.

6.

7.

8.

9.

10.

11.

12.

.S. v. Bacto Unidisk

1906, ch. 34 Stat. 768.

No.343 (April 28, 1969).

S. 1944, 73d Cong., 1st Sess. $2(b)(3) (1933).

AMP v. Gardner 389 F.2d 229 (1968).

79 Cong. Rec. 4841 (74th Cong. 1st Sess., 1935).

389 F.2d 829.

44 Ind. L.J. 504 (1969).

Federal Food, Drug, and Cosmetic Act of June 25,1938,

ch. 675, 52 Stat 1040, $201(p).

Address by Mrs. Virginia Knauer, Special Assistant for Consumer Affairs before the National Conference on Med

ical Devices, Sep. 6, 1969. (page 10 of the text of the speech).

13 Address by President Richare M. Nixon to the Congress

13.

14.

of the United States, October 30, 1969. (Document No. 91-188, at 9).

See ppendix for list of the 28 Bills.

Washington Post, Feb. 20, 1969, at A2.

Consumer Reports at 257, April, 1970.

The Electronic Engineer, July 1969 at 37.

19. Paper by Robert L. Ringler, Ph.D. presented

March 19, 1970 at 1.

See Appendix for detailed Literature Study by the FDA. 20. See Appendix for the FDA Literature Studies of the

21.

22.

IUD injuries.

43 Hospitals 65, Dec.1, 1969.

21 U.S.C. $ 360 (b), Federal Food, Drug, and Cosmetic

Act 21 $510 (b).

23. 21 U.S.C. $ 355, Federal Food, Drug, and Cosmetic Act

21 $ 505.

24. Id. at # 505.

25. 21 U.S.C. $ 374(a)(2), Federal Food, Drug, and Cosmetic

26.

Act 21 $ 704 (a)(2).

21 U.S.C. $355 (e), Federal Food, Drug, and Cosmetic Act

21 $ 505(e).

27. Id. at $ 505 (e).

21 U.S.C. $ 351, Federal Food, Drug, and Cosmetic Act

21 $ 501.

281 21 U.S.C. $352, Federal Food, Drug, and Cosmetic Act 21 $ 502.

29. 21 U.S.C. $334, Federal ood, Drug, and Cosmetic Act

32.

33.

34.

210 JAMA 1749, Dec.1, 1969.

Consumer Reports at 257.

Id. at 257. or Federal Food, Drug, and Cosmetic Act

36.

25 Food, Drug, and Cosm. L.J. 238 (1970).

Health and cientific Affairs U.S. Department of Health, Education, and Welfare, before the Second National

52.

Conference on Electronics in Medicine, San Francisco,

California, Feb. 12, 1970.

Medical World News at 11.

***NOTE***