Browse regulations

Establishes FDA procedures to ban medical devices based on substantial deception or unreasonable and substantial risk, and lists specific banned devices including powdered surgical gloves, absorbable glove lubricating powder, prosthetic hair fibers, and electrical aversive conditioning devices.

Imposes billions in compliance costs, stifles innovation, creates regulatory capture risks, assumes unconstitutional federal authority over local medical practice, and substitutes bureaucratic prior restraint for market-driven safety improvements and tort liability.

This regulation classifies neurological medical devices into three risk-based categories (Class I, II, III) and establishes corresponding regulatory requirements including premarket approval for Class III devices, special controls for Class II, and general controls for Class I. It includes detailed mandates for software documentation, clinical performance testing, biocompatibility, electrical safety, electromagnetic compatibility, labeling, and manufacturing practices.

The regulation imposes massive hidden compliance costs—exceeding $2 trillion annually across all federal rules—that burden small innovators, raise healthcare prices, and delay access to lifesaving technologies. It creates regulatory capture where large incumbents influence rules to their advantage while stifling competition. Federal overreach violates Tenth Amendment principles, supplanting state and private certification systems that could more efficiently balance safety and innovation. Unseen consequences include reduced R&D investment, fewer startups, slower adoption of breakthrough devices, and worsened healthcare disparities. The assumption that centralized bureaucrats can optimize device safety better than decentralized market processes—coupled with tort law and professional standards—contradicts the free-market principles of Mises, Hayek, and Friedman.

FDA regulations for acidified foods manufacturing, including pH control, thermal processing, personnel training, record-keeping, and container coding to prevent foodborne illness from low-acid foods with added acids

Excessive federal micromanagement of food processing that could be handled by state-level health departments, creating $2+ trillion compliance costs while small businesses bear disproportionate burden; basic food safety principles are common knowledge and industry self-regulation would achieve same goals without federal bureaucracy

FDA regulation establishing technical requirements for thermal processing of low-acid foods in hermetically sealed containers to ensure commercial sterility and prevent foodborne illness. Covers retort equipment specifications, temperature and pressure controls, operator training, and process monitoring.

Deletion would risk fatal botulism outbreaks; private alternatives cannot assure commercial sterility because consumers cannot verify safety ex ante, testing is destructive, and the catastrophic externalities of contamination justify mandatory, uniform engineering standards that are hard to replicate voluntarily.

Establishes procedures for FDA regulatory hearings when the Commissioner considers enforcement actions (detentions, withdrawals, recalls, etc.). Provides notice, hearing requests, presiding officer rules, conduct standards, record requirements, and decision procedures. Designed to ensure due process in FDA enforcement while maintaining informality and agency discretion.

Without these procedures, the FDA could enforce its vast regulatory regime through arbitrary, unreviewable actions. The hearing requirement provides critical due process protections—notice, opportunity to be heard, impartial presiding officer, and reasoned decisions—that prevent agency overreach and protect property rights. While compliance costs exist, eliminating procedural safeguards would create far greater liberty costs: unchecked seizures, product bans, and license revocations without defense. The informal, flexible design minimizes burden while ensuring basic fairness, and the exclusion of most routine enforcement activities keeps scope limited.

This regulation establishes procedures for FDA public hearings, including notice requirements, participation rules, hearing conduct, and record-keeping. It covers discretionary hearings, statutorily required hearings, and formal evidentiary hearings converted to public hearings, with specific procedures for notice publication, participant scheduling, hearing conduct, and transcript maintenance.

This regulation creates unnecessary bureaucratic overhead and compliance costs without providing meaningful benefits. The FDA already has authority to conduct hearings through other mechanisms, and these detailed procedures add complexity without improving outcomes. The rules around notice publication, participant scheduling, and transcript requirements create a procedural maze that delays decision-making and increases administrative burden on both the agency and participants, ultimately slowing down the drug approval process and harming patients who need timely access to treatments.

FDA advisory committee procedures for public hearings, including meeting conduct, public participation, closed sessions for confidential information, and member appointment rules.

This regulation creates unnecessary bureaucratic overhead for FDA advisory committees, imposing rigid procedural requirements that delay medical and scientific decision-making. The extensive public hearing requirements and closed session protocols add compliance costs without improving outcomes, while the complex member appointment procedures create barriers to expert participation. Free markets and scientific progress would be better served by allowing FDA to operate with more flexibility and less regulatory constraint.

Procedural rules for FDA Public Boards of Inquiry covering: when boards are convened; member selection with conflict-of-interest rules; informal hearing format as scientific inquiry; document submission and service requirements; administrative record preparation; and public access to records.

Adds billions to the $2T regulatory burden through unnecessary complexity; small businesses disproportionately harmed by arcane filing requirements and deadlines; slows FDA approvals, delaying life-saving products; confidential nominee selection lacks transparency. Essential fairness and expertise could be achieved with streamlined rules—this labyrinth entrenches bureaucratic power, not public welfare.

This FDA regulation (21 CFR Part 12) establishes detailed procedural rules for formal evidentiary public hearings, including how to file objections and requests for hearings, standards for granting hearings, and hearing conduct procedures.

The regulation imposes complex, costly procedural requirements that create barriers to challenging FDA actions, favoring sophisticated incumbents. It adds to the $2 trillion annual compliance burden and the 185,000-page CFR labyrinth, while providing only limited check on agency power. Small businesses and citizens face disproportionate burdens navigating these rules, enabling regulatory capture through procedural delays.

FDA procedural regulations governing petitions, hearings, and administrative proceedings under federal food, drug, and cosmetic laws, establishing filing requirements, public participation processes, and decision-making procedures.

These regulations create unnecessary bureaucratic overhead for FDA administrative processes without improving public safety or efficiency. The extensive procedural requirements increase compliance costs for businesses and citizens while creating delays in bringing beneficial products to market. Many procedures could be streamlined or handled through simpler mechanisms without sacrificing transparency or due process.

This regulation implements labor surplus area classification and agricultural housing standards. It establishes criteria for designating areas with high unemployment rates, sets housing standards for agricultural workers, and provides procedures for variances and complaints.

Creates unnecessary federal bureaucracy that distorts labor markets, imposes costly housing regulations on farmers, and duplicates state/local oversight. The unseen costs include reduced agricultural productivity and barriers to entry for small farmers.

Procedural rules governing the U.S. International Trade Commission's investigations under the Tariff Act of 1930, primarily covering antidumping and countervailing duty cases. Establishes processes for petition filing, record maintenance, business proprietary information protection through administrative protective orders, ex parte meeting disclosure, service requirements, and enforcement mechanisms for non-compliance.

Americans would be worse off without these procedural safeguards: they ensure fair, transparent, and efficient administration of trade remedy laws while protecting legitimate confidential business information. Eliminating these rules would create chaos, undermine due process, expose trade secrets, and impair the Commission's ability to lawfully enforce statutory duties against dumped or subsidized imports that harm domestic industries. The administrative framework balances transparency with necessary protections, enabling agencies to fulfill their Congressionally-mandated role.

This regulation establishes the procedures for entry of merchandise into the United States, including documentation requirements, timing, bonding, and special permits for immediate delivery of imported goods under the Tariff Act of 1930.

This regulation facilitates international trade by providing clear procedures for merchandise entry, ensuring proper documentation, duty collection, and compliance with customs laws. Without it, the US would lack systematic procedures for legal importation, creating chaos at ports and undermining revenue collection.

Regulation implements the Contract Disputes Act of 1978 for TVA contracts, establishing a mandatory administrative process for resolving disputes. It defines terms, sets claim requirements, outlines Contracting Officer decisions, creates the TVA Board of Contract Appeals, and provides procedures for appeals, hearings, discovery, and subpoenas, with expedited tracks for claims under $10,000 and $50,000.

This regulation forces contractors into a bureaucratic administrative tribunal that denies access to Article III courts and juries, violating due process principles. The unseen costs include: conflict of interest (Contracting Officers judge their own actions), lack of precedent in 'expedited' cases, broad discretion for the Chairman to reassign appeals arbitrarily, and forced administrative delay rather than timely judicial resolution. Contract disputes are matters of private rights that belong in regular courts—not in specialized agency forums designed to protect the government. Eliminating this board would restore constitutional judicial independence and reduce compliance complexity for small contractors.

Regulation establishes mandatory public participation guidelines for the Upper Mississippi River Basin Commission's Comprehensive Master Management Plan, requiring surveys, meetings, hearings, information/education programs, evaluations, and detailed reporting by the Commission and participating federal, state, and local agencies.

Imposes substantial compliance costs through mandated bureaucratic processes that duplicate natural stakeholder engagement and existing administrative procedures. Resources diverted to surveys, hearings, reporting, and centralized information centers detract from actual river management. Subjective participation standards invite regulatory capture and mission creep while adding to the $2 trillion annual regulatory burden on households and small businesses.