Medical Device Regulatory Modernization Act of 1997

Summary

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 annual FDA and Comptroller General reports to specified congressional committees. (Sec. 3) Directs the Secretary of Health and Human Services, when there is a scientific controversy between a regulated person and the Secretary, to establish a procedure under which the regulated person may request a review of the disputed subject matter. (Sec. 4) Revises or imposes requirements regarding: (1) investigational device exemptions; (2) premarket approval requirements (mandating a device review priority); (3) humanitarian device exceptions; (4) safety and effectiveness performance standards (allowing recognition of self-certifiable consensus standards); (5) effectiveness determinations (as used in classifying devices); (6) reliance on postmarket controls to expedite classification; (7) substantial equivalence; (8) labeling (as affecting premarket approval); (9) supplemental applications; (10) promotional material representations; (11) premarket notification; (12) initial classification; (13) classification panels; and (14) premarket approval application review (allowing review by accredited persons). (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 regulated as class III subject to general and appropriate special controls. (Sec. 14) Modifies requirements regarding: (1) device tracking; (2) postmarket surveillance; and (3) good manufacturing practice regulations (including foreign harmonization) and inspections (including adding references to accredited entities and post-inspection procedural requirements). (Sec. 17) Removes distributors from recordkeeping and reporting requirements. Removes reporting requirements regarding certain certification and removals and corrections. Mandates new user reporting regulations limiting user reporting to a user subset to create a representative profile of user reports. (Sec. 18) Prohibits subjecting a person to penalties if the person acted in good faith and had no reason to believe the acts violated the law. (Sec. 19) Mandates an information system to track the status of each submission requesting FDA action. (Sec. 20) Prohibits actions by the Secretary of Health and Human Services under the FDCA from requiring the preparation of an environmental assessment or impact statement. (Sec. 22) Regulates communications to non-FDA persons regarding certain matters before completion of related investigations.

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Timeline

1. 22 May 1997

   Introduced

   Referred to the House Committee on Commerce.

   Source: IntroReferral

2. 22 May 1997

   Introduced

   Sponsor introductory remarks on measure. (CR E1043)

   Source: IntroReferral

3. 22 May 1997

   Introduced

   Introduced in House

   Source: IntroReferral

4. 22 May 1997

   Introduced

   Introduced in House

   Source: IntroReferral

5. 14 July 1997

   Referred

   Referred to the Subcommittee on Health and Environment.

   Source: Committee

6. 17 September 1997

   Committee

   Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote.

   Source: Committee

7. 17 September 1997

   Committee

   Subcommittee Consideration and Mark-up Session Held.

   Source: Committee

8. 26 September 1997

   Reported

   Ordered to be Reported (Amended) by Voice Vote.

   Source: Committee

9. 26 September 1997

   Committee

   Committee Consideration and Mark-up Session Held.

   Source: Committee

10. 6 October 1997

    Calendars

    Placed on the Union Calendar, Calendar No. 178.

    Source: Calendars

11. 6 October 1997

    Reported

    Reported (Amended) by the Committee on Commerce. H. Rept. 105-307.

    Source: Committee

12. 6 October 1997

    Reported

    Reported (Amended) by the Committee on Commerce. H. Rept. 105-307.

    Source: Committee

Votes

No vote records are attached yet.

Versions

• Reported in House · 6 October 1997 · Download file
• Introduced in House · 22 May 1997 · Download file

Documents

6 official files

• Reported in House (text)

  Reported in House · EN · 6 October 1997

  ViewDownloadOpen at official source

• Reported in House (PDF)

  Reported in House · EN · 6 October 1997

  ViewDownloadOpen at official source

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  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

• Reported to House with amendment(s)

  summary · EN · 6 October 1997

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  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

• Introduced in House (text)

  Introduced in House · EN · 22 May 1997

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  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

• Introduced in House (PDF)

  Introduced in House · EN · 22 May 1997

  ViewDownloadOpen at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

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  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

• Introduced in House

  summary · EN · 22 May 1997

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Rep. Barton, Joe [R-TX-6] · R · Sponsor
• Rep. Eshoo, Anna G. [D-CA-18] · D · Sponsor
• Rep. Bliley, Tom [R-VA-7] · R · Sponsor
• Rep. Bilirakis, Michael [R-FL-9] · R · Sponsor
• Rep. Greenwood, James C. [R-PA-8] · R · Sponsor
• Rep. Schaefer, Dan [R-CO-6] · R · Sponsor
• Rep. Hall, Ralph M. [R-TX-4] · D · Sponsor
• Rep. Hastert, J. Dennis [R-IL-14] · R · Sponsor
• Rep. Manton, Thomas J. [D-NY-7] · D · Sponsor
• Rep. Tauzin, W. J. (Billy) [R-LA-3] · R · Sponsor
• Rep. Towns, Edolphus [D-NY-10] · D · Sponsor
• Rep. Oxley, Michael G. [R-OH-4] · R · Sponsor
• Rep. Furse, Elizabeth [D-OR-1] · D · Sponsor
• Rep. Upton, Fred [R-MI-6] · R · Sponsor
• Rep. Rush, Bobby L. [D-IL-1] · D · Sponsor
• Rep. Stearns, Cliff [R-FL-6] · R · Sponsor
• Rep. Paxon, Bill [R-NY-27] · R · Sponsor
• Rep. Gillmor, Paul E. [R-OH-5] · R · Sponsor
• Rep. Klug, Scott L. [R-WI-2] · R · Sponsor
• Sen. Crapo, Mike [R-ID] · R · Sponsor
• Rep. Cox, Christopher [R-CA-48] · R · Sponsor
• Rep. Deal, Nathan [R-GA-9] · R · Sponsor
• Rep. Largent, Steve [R-OK-1] · R · Sponsor
• Sen. Burr, Richard [R-NC] · R · Sponsor
• Rep. Bilbray, Brian P. [R-CA-50] · R · Sponsor
• Rep. Whitfield, Ed [R-KY-1] · R · Sponsor
• Rep. Ganske, Greg [R-IA-4] · R · Sponsor
• Rep. Norwood, Charles W. [R-GA-9] · R · Sponsor
• Rep. White, Rick [R-WA-1] · R · Sponsor
• Sen. Coburn, Tom [R-OK] · R · Sponsor
• Rep. Lazio, Rick [R-NY-2] · R · Sponsor
• Rep. Cubin, Barbara [R-WY-At Large] · R · Sponsor
• Rep. Rogan, James E. [R-CA-27] · R · Sponsor
• Rep. Shimkus, John [R-IL-15] · R · Sponsor
• Rep. Gordon, Bart [D-TN-6] · D · Sponsor
• Rep. Ehrlich, Robert L., Jr. [R-MD-2] · R · Sponsor
• Rep. Ramstad, Jim [R-MN-3] · R · Sponsor
• Rep. Wynn, Albert Russell [D-MD-4] · D · Sponsor
• Rep. McCarthy, Karen [D-MO-5] · D · Sponsor
• Rep. Pallone, Frank [D-NJ-6] · D · Sponsor
• Rep. Fazio, Vic [D-CA-3] · D · Cosponsor
• Rep. Gekas, George W. [R-PA-17] · R · Cosponsor
• Rep. Holden, Tim [D-PA-17] · D · Cosponsor
• Rep. Sawyer, Tom [D-OH-14] · D · Cosponsor
• Rep. Peterson, Collin C. [D-MN-7] · D · Cosponsor
• Rep. Cunningham, Randy (Duke) [R-CA-50] · R · Cosponsor
• Rep. McGovern, James P. [D-MA-2] · D · Cosponsor
• Rep. Campbell, Tom [R-CA-15] · R · Cosponsor

Showing 48 of 154 sponsors and actors.

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