Novel Device Regulatory Relief Act of 2011

Referred to the Subcommittee on Health.

Congressional Research Service

Official summary

Version 00 · Introduced in House · Oct 14, 2011

Novel Device Regulatory Relief Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise the process for requesting classification for a type of medical device that has not been previously classified by removing the requirement that a person can only file a request for classification of a new medical device after the Secretary of Health and Human Services (HHS) classifies the device as a class III device in response to the person filing a notice of intent to market the device.

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People & committees

Who introduced it

Rep. Bilbray, Brian P. [R-CA-50] · R–CA

Committees

Energy and Commerce Committee

18 cosponsorship records, including any withdrawals

Legislative record

Actions

A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.

Oct 18, 2011
Referred to the Subcommittee on Health.
Oct 14, 2011
Referred to the House Committee on Energy and Commerce.
Oct 14, 2011
Introduced in House
Oct 14, 2011
Introduced in House

Primary sources

Bill text & related measures

Text links open the official source. We currently store references to these documents.

Introduced in House · Oct 14, 2011 Formatted Text PDF Formatted XML

Related bills identified by Congress.gov

No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.

Source last updated: Aug 14, 2025. Consult Congress.gov for the current record.

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Neutral evidence review

Objective

Analyze H.R.3203 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.

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Discuss H.R.3203, 112th Congress: Novel Device Regulatory Relief Act of 2011

Official record: https://www.congress.gov/bill/112th-congress/house-bill/3203

Text version to examine: Introduced in House · 2011-10-14.

Official full text: https://www.congress.gov/112/bills/hr3203/BILLS-112hr3203ih.htm

Imported record last updated by the source: 2025-08-14T14:17:59Z. Verify current status and distinguish any later version from the version above.

Read the official text before answering. If you cannot access it, say so and ask me to provide it; do not assume a link means you have read the document. Distinguish proposals from enacted law, cite sources, and separate facts, interpretation, and uncertain predictions. Include counterarguments even when using a particular perspective.

Analyze H.R.3203 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.

Fairness and public impact

Progressive lens

Examine H.R.3203 through a progressive lens, focusing on fairness, access, economic inequality, and effects on vulnerable communities. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and distinguish stated goals from demonstrated outcomes.

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Discuss H.R.3203, 112th Congress: Novel Device Regulatory Relief Act of 2011

Official record: https://www.congress.gov/bill/112th-congress/house-bill/3203

Text version to examine: Introduced in House · 2011-10-14.

Official full text: https://www.congress.gov/112/bills/hr3203/BILLS-112hr3203ih.htm

Imported record last updated by the source: 2025-08-14T14:17:59Z. Verify current status and distinguish any later version from the version above.

Read the official text before answering. If you cannot access it, say so and ask me to provide it; do not assume a link means you have read the document. Distinguish proposals from enacted law, cite sources, and separate facts, interpretation, and uncertain predictions. Include counterarguments even when using a particular perspective.

Examine H.R.3203 through a progressive lens, focusing on fairness, access, economic inequality, and effects on vulnerable communities. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and distinguish stated goals from demonstrated outcomes.

Institutions and government scope

Conservative lens

Examine H.R.3203 through a conservative lens, focusing on fiscal responsibility, institutional stability, federalism, and the scope of government. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and any provisions that challenge this perspective.

View full prompt & sources

Discuss H.R.3203, 112th Congress: Novel Device Regulatory Relief Act of 2011

Official record: https://www.congress.gov/bill/112th-congress/house-bill/3203

Text version to examine: Introduced in House · 2011-10-14.

Official full text: https://www.congress.gov/112/bills/hr3203/BILLS-112hr3203ih.htm

Imported record last updated by the source: 2025-08-14T14:17:59Z. Verify current status and distinguish any later version from the version above.

Read the official text before answering. If you cannot access it, say so and ask me to provide it; do not assume a link means you have read the document. Distinguish proposals from enacted law, cite sources, and separate facts, interpretation, and uncertain predictions. Include counterarguments even when using a particular perspective.

Examine H.R.3203 through a conservative lens, focusing on fiscal responsibility, institutional stability, federalism, and the scope of government. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and any provisions that challenge this perspective.

Individual rights and government power

Liberty lens

Examine H.R.3203 through a civil-liberties and limited-government lens. Consider individual rights, privacy, voluntary choice, accountability, and government power. Explain tradeoffs, possible safeguards, and the strongest counterarguments without assuming the proposal is beneficial or harmful.

View full prompt & sources

Discuss H.R.3203, 112th Congress: Novel Device Regulatory Relief Act of 2011

Official record: https://www.congress.gov/bill/112th-congress/house-bill/3203

Text version to examine: Introduced in House · 2011-10-14.

Official full text: https://www.congress.gov/112/bills/hr3203/BILLS-112hr3203ih.htm

Imported record last updated by the source: 2025-08-14T14:17:59Z. Verify current status and distinguish any later version from the version above.

Read the official text before answering. If you cannot access it, say so and ask me to provide it; do not assume a link means you have read the document. Distinguish proposals from enacted law, cite sources, and separate facts, interpretation, and uncertain predictions. Include counterarguments even when using a particular perspective.

Examine H.R.3203 through a civil-liberties and limited-government lens. Consider individual rights, privacy, voluntary choice, accountability, and government power. Explain tradeoffs, possible safeguards, and the strongest counterarguments without assuming the proposal is beneficial or harmful.