Skip to main navigation Skip to main content
Home
Consumer Healthcare Products Association
Taking healthcare personally.

User account menu

  • About CHPA
  • Membership
  • Health In Hand Foundation
  • Career Center
  • Login
  • Our Issues
      1. OTC Medicines
        1. Acetaminophen
        2. Children's Cough and Cold Medicines
        3. DXM (Dextromethorphan)
        4. Monograph Reform
        5. NSAIDs
        6. OTC Distribution
        7. Pediatrics Medicine
        8. PE (Phenylephrine)
        9. PSE (Pseudoephedrine)
        10. RX-to-OTC Switch
        11. Sunscreen
        12. Take Back/Drug Disposal
      2. Dietary Supplements
        1. CBD and Hemp Oil
        2. DSHEA
        3. Immunity
        4. New Dietary Ingredients
        5. Probiotics
        6. Vitamins and Minerals
      3. OTC Medical Devices
        1. 510(K) Modifications
      4. Other Issues
        1. Branding
        2. Digital Health
        3. FSA/HSA
        4. Good Manufacturing Practices
        5. Health Literacy
        6. Ingredient Safety
        7. Labeling
        8. NPLEx (National Precursor Log Exchange)
        9. Packaging
        10. PFAS
        11. Quality
        12. Research
        13. Sales Tax Exemption
        14. Supply Chain
        15. Sustainability
        16. Tariffs
        17. Titanium Dioxide
  • Public Policy & Regulatory
      1. Regulation
        1. Regulation of OTC Medicines
        2. Regulation of Dietary Supplements
        3. Regulation of OTC Medical Devices
        4. Submissions
        5. FDA Annual Forecast
        6. Current Good Manufacturing Practices
      2. Federal Legislative Priorities
        1. Cargo Theft
        2. Tariffs: Ongoing Actions and Industry Guidance
        3. Dietary Supplements Access Act
        4. Expanding FSA/HSA Eligibility for Oral Care Products
      3. State & Local Government Affairs
        1. Critical Ingredients & Chemicals
        2. Dietary Supplements in the States
        3. OTC Medications in the States
        4. Sustainability Issues in the States
        5. State Government Reports
      4. Voluntary Codes and Guidelines
        1. OTC Voluntary Codes and Guidelines
        2. Industry Self-Regulation for Dietary Supplements
      5. Advisory Documents
        1. In-use Product Stability Testing for OTC Products – Advisory Document
        2. OTC Monograph Product Technical Data Outline
  • Events & Education
      1. Annual Self-Care Leadership Summit
      2. CHPA Academy
        1. Consumer Healthcare 101
      3. Regulatory, Scientific & Quality Conference
        1. William Cooley Regulatory & Scientific Affairs Career Achievement Award
      4. Health In Hand Foundation Gala
        1. Self-Care Marketing Awards
        2. Marketing Forum
      5. Meetings & Education Calendar
        1. Become a Sponsor
  • About Consumer Healthcare
      1. Research & Data
        1. Research Reports
        2. OTC Sales Statistics
        3. OTC Medical Device Statistics
        4. Dietary Supplement Resource Library
      2. Multimedia
        1. Infographics
        2. Videos
        3. Podcast
      3. FAQs
      4. Activities & Initiatives
        1. Survey: Americans Overwhelmingly Want Modernized Regulations for Dietary Supplements
        2. Preventing Dextromethorphan Abuse
        3. Preventing Illegal Meth Production
        4. Safe Use of Acetaminophen
        5. Tax Free OTC
        6. The Value of OTC Medicines
  • News
Open Search
Open Menu

Main navigation

  • Our Issues
    • OTC Medicines
      • Acetaminophen
      • Children's Cough and Cold Medicines
      • DXM (Dextromethorphan)
      • Monograph Reform
        • User Fees
      • NSAIDs
      • OTC Distribution
      • Pediatrics Medicine
      • PE (Phenylephrine)
      • PSE (Pseudoephedrine)
      • RX-to-OTC Switch
      • Sunscreen
      • Take Back/Drug Disposal
    • Dietary Supplements
      • CBD and Hemp Oil
      • DSHEA
      • Immunity
      • New Dietary Ingredients
      • Probiotics
      • Vitamins and Minerals
    • OTC Medical Devices
      • 510(K) Modifications
    • Other Issues
      • Branding
      • Digital Health
      • FSA/HSA
      • Good Manufacturing Practices
      • Health Literacy
      • Ingredient Safety
      • Labeling
      • NPLEx (National Precursor Log Exchange)
      • Packaging
      • PFAS
      • Quality
      • Research
      • Sales Tax Exemption
      • Supply Chain
      • Sustainability
      • Tariffs
      • Titanium Dioxide
  • Public Policy & Regulatory
    • Regulation
      • Regulation of OTC Medicines
        • Child-Resistant Packaging
        • Switch List
        • Drug Distribution and National Uniformity
        • OTC Drug Advertising
        • Structured Product Labeling
      • Regulation of Dietary Supplements
        • Labeling Dietary Supplements
        • Marketing and Advertising Dietary Supplements
        • Standardized Information on Dietary Ingredients (SIDI)
        • Dietary Supplement Safety
      • Regulation of OTC Medical Devices
      • Submissions
      • FDA Annual Forecast
        • Effectiveness of Phenylephrine as an Oral Decongestant
        • Pediatric Cough/Cold Dosing
        • Risks Associated with Codeine-Containing Cough Medicine
        • Pediatric Acetaminophen Dosing
        • Risks Associated with Propylhexedrine Abuse and Misuse
        • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and Oligohydramnios
        • Oral Healthcare in Infants and Children - Benzocaine and/or Phenol Preparations
        • Proposed Safety Administrative Order for Serious Skin reactions Associated with Acetaminophen
        • Anticaries Test Methods
        • Risks Associated with use of Ipecac Syrp as OTC Poison Treatment
      • Current Good Manufacturing Practices
    • Federal Legislative Priorities
      • Cargo Theft
      • Tariffs: Ongoing Actions and Industry Guidance
        • Additional Tariff Documents and Informational Opportunities
      • Dietary Supplements Access Act
      • Expanding FSA/HSA Eligibility for Oral Care Products
    • State & Local Government Affairs
      • Critical Ingredients & Chemicals
        • Acetaminophen
        • Color Additives
        • Dextromethorphan
        • Diphenhydramine
        • Loperamide
        • Pseudoephedrine
        • Volatile Organic Compounds
      • Dietary Supplements in the States
      • OTC Medications in the States
        • Animal Testing
        • Dispensing Authority
        • Ingredient Disclosure
        • Emergency Scheduling of Ingredients
        • Insurance Coverage
        • Labeling OTC Medications
        • Sales Tax
        • Supply Chain
        • Vending Machine Sales
      • Sustainability Issues in the States
        • Batteries in OTC Devices
        • Chemical Restrictions in Children’s Products
        • Drug Take-Back
        • Green Chemistry
        • Microplastics
        • PFAS
        • Packaging
        • Proposition 65
        • Sunscreen
      • State Government Reports
    • Voluntary Codes and Guidelines
      • OTC Voluntary Codes and Guidelines
      • Industry Self-Regulation for Dietary Supplements
    • Advisory Documents
      • In-use Product Stability Testing for OTC Products – Advisory Document
      • OTC Monograph Product Technical Data Outline
  • Events & Education
    • Annual Self-Care Leadership Summit
    • CHPA Academy
      • Consumer Healthcare 101
    • Regulatory, Scientific & Quality Conference
      • William Cooley Regulatory & Scientific Affairs Career Achievement Award
    • Health In Hand Foundation Gala
      • Self-Care Marketing Awards
      • Marketing Forum
    • Meetings & Education Calendar
      • Become a Sponsor
  • About Consumer Healthcare
    • Research & Data
      • Research Reports
      • OTC Sales Statistics
      • OTC Medical Device Statistics
      • Dietary Supplement Resource Library
    • Multimedia
      • Infographics
      • Videos
      • Podcast
    • FAQs
    • Activities & Initiatives
      • Survey: Americans Overwhelmingly Want Modernized Regulations for Dietary Supplements
      • Preventing Dextromethorphan Abuse
      • Preventing Illegal Meth Production
      • Safe Use of Acetaminophen
      • Tax Free OTC
      • The Value of OTC Medicines
  • News

User account menu

  • About CHPA
  • Membership
  • Health In Hand Foundation
  • Career Center
  • Login
  • LinkedIn
  • YouTube
  • Twitter
  • Facebook

Breadcrumb

  1. Home
  2. Public Policy & Regulatory
  3. Regulation
  4. Submissions
  5. Comments Regarding Predetermined Change Control Plans for Medical Devices;

Comments Regarding Predetermined Change Control Plans for Medical Devices;

Share page:
Docket Number:
FDA–2024-D-2338
Download Document
Issues:
OTC Medical Devices
510(K) Modifications
Other Issues
Labeling

Related Posts

2025 Mid-Year Impact Report Page 1
2025 Mid-Year Impact Report

Jun 20, 2025

FDA Approved Stamp with OTC Medicines

Letter

Letter Regarding Office of Management & Budget Request for Information: Deregulation

May 12, 2025

Dr. Scott Furness, CHPA's New Senior Vice President of Regulatory & Scientific Affairs

Press Releases and Statements

Veteran Scientist & Regulator Joins CHPA’s Senior Management Team

May 12, 2025

Consumer Healthcare Products Association | Taking healthcare personally.

  • LinkedIn
  • YouTube
  • Twitter
  • Facebook
  • Instagram

Consumer Healthcare Products Association
1625 Eye Street, NW, Suite 600
Washington, DC 20006
T: 202.429.9260
F: 202.223.6835

About Us

  • Contact Us
  • Our Members
  • Our Team

Quick Links

  • Health In Hand
  • Know Your Dose
  • Up and Away

© 2025 Consumer Healthcare Products Association - CHPA. All Rights Reserved

Footer

  • Privacy Policy
  • Terms of Use
  • Sitemap