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Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries

Titles (3)

Short Titles

Short Titles - House of Representatives

Short Titles as Reported to House

Medical Device Regulatory Modernization Act of 1997

Short Titles as Introduced

Medical Device Regulatory Modernization Act of 1997

Official Titles

Official Titles - House of Representatives

Official Title as Introduced

To amend the Federal Food, Drug, and Cosmetic Act to facilitate the development, clearance, and use of devices to maintain and improve the public health and quality of life of the citizens of the United States.


Actions Overview (2)

Date
10/06/1997Reported (Amended) by the Committee on Commerce. H. Rept. 105-307.
05/22/1997Introduced in House

All Actions (10)

Date
10/06/1997Placed on the Union Calendar, Calendar No. 178.
Action By: House of Representatives
10/06/1997Reported (Amended) by the Committee on Commerce. H. Rept. 105-307.
Action By: Committee on Commerce
09/26/1997Ordered to be Reported (Amended) by Voice Vote.
Action By: Committee on Commerce
09/26/1997Committee Consideration and Mark-up Session Held.
Action By: Committee on Commerce
09/17/1997Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote.
Action By: House Commerce Subcommittee on Health and Environment
09/17/1997Subcommittee Consideration and Mark-up Session Held.
Action By: House Commerce Subcommittee on Health and Environment
07/14/1997Referred to the Subcommittee on Health and Environment.
Action By: Committee on Commerce
05/22/1997Referred to the House Committee on Commerce.
Action By: House of Representatives
05/22/1997Sponsor introductory remarks on measure. (CR E1043)
Action By: House of Representatives
05/22/1997Introduced in House
Action By: House of Representatives

Cosponsors (152)

* = Original cosponsor
CosponsorDate Cosponsored
Rep. Eshoo, Anna G. [D-CA-14]* 05/22/1997
Rep. Bliley, Tom [R-VA-7]* 05/22/1997
Rep. Bilirakis, Michael [R-FL-9]* 05/22/1997
Rep. Greenwood, James C. [R-PA-8]* 05/22/1997
Rep. Schaefer, Dan [R-CO-6]* 05/22/1997
Rep. Hall, Ralph M. [D-TX-4]* 05/22/1997
Rep. Hastert, J. Dennis [R-IL-14]* 05/22/1997
Rep. Manton, Thomas J. [D-NY-7]* 05/22/1997
Rep. Tauzin, W. J. (Billy) [R-LA-3]* 05/22/1997
Rep. Towns, Edolphus [D-NY-10]* 05/22/1997
Rep. Oxley, Michael G. [R-OH-4]* 05/22/1997
Rep. Furse, Elizabeth [D-OR-1]* 05/22/1997
Rep. Upton, Fred [R-MI-6]* 05/22/1997
Rep. Rush, Bobby L. [D-IL-1]* 05/22/1997
Rep. Stearns, Cliff [R-FL-6]* 05/22/1997
Rep. Paxon, Bill [R-NY-27]* 05/22/1997
Rep. Gillmor, Paul E. [R-OH-5]* 05/22/1997
Rep. Klug, Scott L. [R-WI-2]* 05/22/1997
Rep. Crapo, Mike [R-ID-2]* 05/22/1997
Rep. Cox, Christopher [R-CA-47]* 05/22/1997
Rep. Deal, Nathan [R-GA-9]* 05/22/1997
Rep. Largent, Steve [R-OK-1]* 05/22/1997
Rep. Burr, Richard [R-NC-5]* 05/22/1997
Rep. Bilbray, Brian P. [R-CA-49]* 05/22/1997
Rep. Whitfield, Ed [R-KY-1]* 05/22/1997
Rep. Ganske, Greg [R-IA-4]* 05/22/1997
Rep. Norwood, Charles W. [R-GA-10]* 05/22/1997
Rep. White, Rick [R-WA-1]* 05/22/1997
Rep. Coburn, Tom [R-OK-2]* 05/22/1997
Rep. Lazio, Rick [R-NY-2]* 05/22/1997
Rep. Cubin, Barbara [R-WY-At Large]* 05/22/1997
Rep. Rogan, James E. [R-CA-27]* 05/22/1997
Rep. Shimkus, John [R-IL-20]* 05/22/1997
Rep. Gordon, Bart [D-TN-6]* 05/22/1997
Rep. Ehrlich, Robert L., Jr. [R-MD-2]* 05/22/1997
Rep. Ramstad, Jim [R-MN-3]* 05/22/1997
Rep. Wynn, Albert Russell [D-MD-4]* 05/22/1997
Rep. McCarthy, Karen [D-MO-5]* 05/22/1997
Rep. Pallone, Frank, Jr. [D-NJ-6]* 05/22/1997
Rep. Fazio, Vic [D-CA-3] 06/20/1997
Rep. Gekas, George W. [R-PA-17] 06/20/1997
Rep. Holden, Tim [D-PA-6] 06/20/1997
Rep. Sawyer, Tom [D-OH-14] 06/20/1997
Rep. Peterson, Collin C. [D-MN-7] 06/20/1997
Rep. Cunningham, Randy (Duke) [R-CA-51] 06/20/1997
Rep. McGovern, James P. [D-MA-3] 06/20/1997
Rep. Campbell, Tom [R-CA-15] 06/20/1997
Rep. Buyer, Steve [R-IN-5] 06/20/1997
Rep. Archer, Bill [R-TX-7] 06/20/1997
Rep. Gutknecht, Gil [R-MN-1] 06/20/1997
Rep. Farr, Sam [D-CA-17] 06/20/1997
Rep. Frost, Martin [D-TX-24] 06/20/1997
Rep. Frank, Barney [D-MA-4] 06/20/1997
Rep. Canady, Charles T. [R-FL-12] 06/20/1997
Rep. Cramer, Robert E. (Bud), Jr. [D-AL-5] 06/20/1997
Rep. McHale, Paul [D-PA-15] 06/20/1997
Rep. Foley, Mark [R-FL-16] 06/20/1997
Rep. Neal, Richard E. [D-MA-2] 06/20/1997
Rep. Hayworth, J. D. [R-AZ-6] 06/20/1997
Rep. McKeon, Howard P. "Buck" [R-CA-25] 06/20/1997
Rep. Stump, Bob [R-AZ-3] 06/26/1997
Rep. Taylor, Charles H. [R-NC-11] 06/26/1997
Rep. Horn, Stephen [R-CA-38] 06/26/1997
Rep. Boehner, John A. [R-OH-8] 06/26/1997
Rep. Franks, Bob [R-NJ-7] 06/26/1997
Rep. Hostettler, John N. [R-IN-8] 06/26/1997
Rep. Watts, J. C., Jr. [R-OK-4] 06/26/1997
Rep. Lucas, Frank D. [R-OK-6] 06/26/1997
Rep. Doolittle, John T. [R-CA-4] 06/26/1997
Rep. Thornberry, Mac [R-TX-13] 06/26/1997
Rep. Royce, Edward R. [R-CA-39] 06/26/1997
Rep. Burton, Dan [R-IN-6] 06/26/1997
Rep. Saxton, Jim [R-NJ-3] 06/26/1997
Rep. DeLay, Tom [R-TX-22] 06/26/1997
Rep. Brady, Kevin [R-TX-8] 06/26/1997
Rep. Moakley, John Joseph [D-MA-9] 06/26/1997
Rep. Meehan, Martin T. [D-MA-5] 06/26/1997
Rep. Baesler, Scotty [D-KY-6] 06/26/1997
Rep. Ballenger, Cass [R-NC-10] 06/26/1997
Rep. Sessions, Pete [R-TX-5] 06/26/1997
Rep. Bonilla, Henry [R-TX-23] 06/26/1997
Rep. Hutchinson, Asa [R-AR-3] 06/26/1997
Rep. Granger, Kay [R-TX-12] 06/26/1997
Rep. Johnson, Nancy L. [R-CT-6] 07/17/1997
Rep. Porter, John Edward [R-IL-10] 07/17/1997
Rep. Dooley, Calvin M. [D-CA-20] 07/17/1997
Rep. Combest, Larry [R-TX-19] 07/17/1997
Rep. McIntosh, David M. [R-IN-2] 07/17/1997
Rep. Myrick, Sue Wilkins [R-NC-9] 07/17/1997
Rep. Duncan, John J., Jr. [R-TN-2] 07/17/1997
Rep. Gibbons, Jim [R-NV-2] 07/17/1997
Rep. Shays, Christopher [R-CT-4] 07/17/1997
Rep. Kleczka, Gerald D. [D-WI-4] 07/17/1997
Rep. Forbes, Michael P. [R-NY-1] 07/17/1997
Rep. Johnson, Sam [R-TX-3] 07/17/1997
Rep. Luther, Bill [D-MN-6] 07/17/1997
Rep. Herger, Wally [R-CA-2] 07/17/1997
Rep. Kolbe, Jim [R-AZ-5] 07/17/1997
Rep. Smith, Lamar [R-TX-21] 07/17/1997
Rep. Calvert, Ken [R-CA-43] 07/17/1997
Rep. Sensenbrenner, F. James, Jr. [R-WI-9] 07/17/1997
Rep. Weldon, Dave [R-FL-15] 07/17/1997
Rep. Clyburn, James E. [D-SC-6] 07/17/1997
Rep. Ehlers, Vernon J. [R-MI-3] 07/17/1997
Rep. Talent, Jim [R-MO-2] 07/17/1997
Rep. Tauscher, Ellen O. [D-CA-10] 07/17/1997
Rep. Roukema, Marge [R-NJ-5] 07/17/1997
Rep. Spence, Floyd [R-SC-2] 07/17/1997
Rep. Stenholm, Charles W. [D-TX-17] 07/25/1997
Rep. Kind, Ron [D-WI-3] 07/25/1997
Rep. Tanner, John S. [D-TN-8] 07/25/1997
Rep. Dreier, David [R-CA-28] 07/25/1997
Rep. Danner, Pat [D-MO-6] 07/25/1997
Rep. Pascrell, Bill, Jr. [D-NJ-8] 07/25/1997
Rep. Johnson, Eddie Bernice [D-TX-30] 07/25/1997
Rep. Minge, David [D-MN-2] 07/25/1997
Rep. Pickering, Charles W. "Chip" [R-MS-3] 07/25/1997
Rep. Menendez, Robert [D-NJ-13] 07/25/1997
Rep. Kelly, Sue W. [R-NY-19] 07/25/1997
Rep. Dunn, Jennifer [R-WA-8] 07/25/1997
Rep. Graham, Lindsey [R-SC-3] 07/25/1997
Rep. Bunning, Jim [R-KY-4] 07/25/1997
Rep. Rothman, Steven R. [D-NJ-9] 07/25/1997
Rep. Etheridge, Bob [D-NC-2] 07/25/1997
Rep. Packard, Ron [R-CA-48] 07/25/1997
Rep. Hoekstra, Peter [R-MI-2] 07/25/1997
Rep. Hansen, James V. [R-UT-1] 07/25/1997
Rep. Cook, Merrill [R-UT-2] 07/25/1997
Rep. Kim, Jay [R-CA-41] 07/31/1997
Rep. Frelinghuysen, Rodney P. [R-NJ-11] 07/31/1997
Rep. Reyes, Silvestre [D-TX-16] 07/31/1997
Rep. Sanchez, Loretta [D-CA-46] 07/31/1997
Rep. Capps, Walter [D-CA-22] 07/31/1997
Rep. Chenoweth-Hage, Helen [R-ID-1] 07/31/1997
Rep. Miller, Dan [R-FL-13] 09/11/1997
Rep. Hunter, Duncan [R-CA-52] 09/11/1997
Rep. Goodling, William F. [R-PA-19] 09/11/1997
Rep. Bishop, Sanford D., Jr. [D-GA-2] 09/11/1997
Rep. Rohrabacher, Dana [R-CA-45] 09/11/1997
Rep. Solomon, Gerald B. H. [R-NY-22] 09/11/1997
Rep. Sununu, John E. [R-NH-1] 09/11/1997
Rep. Christensen, Jon [R-NE-2] 09/11/1997
Rep. Thomas, William M. [R-CA-21] 09/11/1997
Rep. Northup, Anne M. [R-KY-3] 09/11/1997
Rep. Pitts, Joseph R. [R-PA-16] 09/11/1997
Rep. Souder, Mark E. [R-IN-4] 09/11/1997
Rep. Berman, Howard L. [D-CA-26] 09/11/1997
Rep. Fawell, Harris W. [R-IL-13] 09/29/1997
Rep. Aderholt, Robert B. [R-AL-4] 09/29/1997
Rep. Cannon, Chris [R-UT-3] 09/29/1997
Rep. Wamp, Zach [R-TN-3] 09/29/1997
Rep. Matsui, Robert T. [D-CA-5] 09/29/1997

Committees (1)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Reports
House Commerce05/22/1997 Referred to
09/26/1997 Markup by
10/06/1997 Reported by H. Rept. 105-307
House Commerce Subcommittee on Health and Environment07/14/1997 Referred to
09/17/1997 Markup by
09/17/1997 Reported by

No related bill information was received for H.R.1710.


Latest Summary (2)

There are 2 summaries for H.R.1710. View summaries

Shown Here:
Reported to House with amendment(s) (10/06/1997)

Medical Device Regulatory Modernization Act of 1997 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to set forth the Food and Drug Administration (FDA) mission and to mandate an annual FDA report to specified congressional committees.

(Sec. 3) Directs the Secretary of Health and Human Services, when there is a scientific controversy between a sponsor, applicant, or manufacturer and the Secretary regarding an FDCA obligation and no specific FDCA provision or regulation provides a right of review, to establish by regulation a procedure under which that party may request a review of the controversy by an appropriate scientific advisory panel.

(Sec. 4) Revises or imposes requirements regarding: (1) investigational device exemptions; (2) expanded access procedures permitting the use of a device for the diagnosis, monitoring, or treatment of conditions that are life-threatening or could be irreversibly debilitating; (3) premarket approval requirements (mandating a device review priority); (4) humanitarian device exceptions; (5) safety and effectiveness device standards (allowing recognition of self-certifiable standards); (6) effectiveness determinations (as used in classifying devices); (7) reliance on postmarket controls to expedite classification; (8) substantial equivalence; (9) labeling (as affecting premarket approval); (10) supplemental applications; (11) premarket notification; (12) initial classification; (13) classification panels; and (14) premarket approval application review.

(Sec. 12) Mandates accreditation of persons to review and initially classify devices.

(Sec. 13) Mandates publication of a list of types of class III devices that are not subject to regulation under specified provisions and for which the Secretary has determined that premarket approval is unnecessary, requiring each to be reclassified into class II or class I.

(Sec. 14) Modifies requirements regarding: (1) device tracking; (2) postmarket surveillance; and (3) good manufacturing practice regulations (including foreign harmonization) and inspections.

(Sec. 17) Modifies recordkeeping and reporting requirements applicable to distributors. Removes reporting requirements regarding annual report filing certifications. Removes references to distributors from provisions relating to removals and corrections. Exempts wholesale distributors who do not manufacture, repackage, process, or relabel a device from provisions requiring annual registration of producers of drugs or devices. Modifies device user facility reporting requirements. Requires, for such facilities that are hospitals or nursing homes, user reporting regulations limiting user reporting to a user subset that constitutes a representative profile of user reports.

(Sec. 18) Mandates an applicant-accessible information system to track the status of each device submission requesting agency action.

(Sec. 20) Prohibits considering a computer software product a device solely because its primary use is related to the provision of health care.

(Sec. 21) Removes from the list of prohibited acts provisions prohibiting, on a drug's or device's labeling or advertising, any suggestion that approval of an application is in effect under, or that the drug or device complies with, specified FDCA provisions.

(Sec. 22) Expresses the sense of the Congress that the availability of a safe, effective, noninvasive glucose meter would greatly enhance the health and well-being of all people with diabetes.