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
  • Public Policy & Regulatory
      1. Regulation
        1. Regulation of OTC Medicines
        2. Regulation of Dietary Supplements
        3. Regulation of Consumer Medical Devices
        4. Submissions
        5. FDA Annual Forecast
        6. Current Good Manufacturing Practices
      2. Federal Legislative Priorities
        1. Cargo Theft
        2. Dietary Supplements Access Act
        3. 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
  • Events & Education
      1. Annual Self-Care Leadership Summit
      2. CHPA Academy
        1. Consumer Healthcare 101
      3. Regulatory, Scientific & Quality Conference
        1. 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. Consumer Medical Device Statistics
        4. Dietary Supplement Resource Library
      2. Multimedia
        1. Infographics
        2. Videos
        3. Podcast
      3. FAQs
      4. Activities & Initiatives
        1. Preventing Dextromethorphan Abuse
        2. Preventing Illegal Meth Production
        3. Safe Use of Acetaminophen
        4. Tax Free OTC
        5. 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
  • 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 Consumer Medical Devices
      • Submissions
      • FDA Annual Forecast
        • 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
      • 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 CMDs
        • 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
  • Events & Education
    • Annual Self-Care Leadership Summit
    • CHPA Academy
      • Consumer Healthcare 101
    • Regulatory, Scientific & Quality Conference
      • 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
      • Consumer Medical Device Statistics
      • Dietary Supplement Resource Library
    • Multimedia
      • Infographics
      • Videos
      • Podcast
    • FAQs
    • Activities & Initiatives
      • 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 on the Proposed Rule: Medical Devices; Quality System Regulation Amendments

Comments on the Proposed Rule: Medical Devices; Quality System Regulation Amendments

Share page:
Docket Number:
FDA–2021–N–0507
Download Document
Issues:
OTC Medical Devices
Other Issues
Quality

Related Posts

Colleagues Examining Data on a computer

Comments

Comments Regarding Provisions Pertaining to Preventing Access to U.S. Sensitive Personal Data and Government-Related Data

Nov 28, 2024

Stylized Graphic of DC government buildings

Polibrief

Per-and Polyfluoroalkyl Substances (PFAS)

Nov 20, 2024

Stylized Graphic of DC government buildings

Polibrief

Consumer Medical Devices

Nov 20, 2024

Consumer Healthcare Products Association | Taking healthcare personally.

  • LinkedIn
  • YouTube
  • Twitter
  • Facebook

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