• Login
    • Join
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Applications
    • Technology
    • Market
    • Other
    • Top 40
    • Buyers Guide
    • Hygiene Directory
    • More
  • Magazine
  • News
  • Exclusives
  • Applications
  • Technology
  • Market
  • Other
  • Top 40
  • Buyers Guide
  • Hygiene Directory
  • Current / Back Issues
    Features
    Editorial
    Columns
    Digital Edition
    Southeast Asia Edition
    eNewsletter Archive
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Biosphere Corporation: Expands into Baby Diaper Production in Ukraine

    Trends in Diapers: Sustainability, Natural Ingredients or Other Features?

    Baby Diapers: A Changing Market

    Ultrasonics for Nonwovens

    Hygiene Machinery Review
    Company Cameo
    Financial News
    Machinery Equipment
    New Products
    Nonwovens News
    Patent Review
    People in the News
    Supplier News
    Top News
    Live From Shows
    Top News
    Armbrust American Adds Meltblown Manufacturing

    First Quality Launches Incognito by Prevail

    Essity Launches Reusable Underwear Product

    Techtextil, Texprocess Postponed to 2022

    Ontex Honored for Mask Production
    Nonwovens Insights
    Online Exclusives
    Absorbent Core
    Adult Incontinence
    Antimicrobials
    Apparel
    Automotive and Transportation
    Chemicals / Adhesives
    Construction
    Contract Services
    Diaper, Baby
    Electronics
    Feminine Hygiene
    Fibers
    Filtration
    Flame Retardance
    Geotextile / Agrotextile
    Home Products
    Hygiene Film/Components
    Industrial / Institutional
    Inspection / Quality Control
    Machinery and Equipment
    Medical
    Wipes

    Armbrust American Adds Meltblown Manufacturing

    First Quality Launches Incognito by Prevail

    Essity Launches Reusable Underwear Product

    Shemesh Adds U.S. Headquarters

    TZMO USA, Special Needs Group Form Partnership
    Air Through Bonding
    Airlaid
    Carded/Carding
    Chemical Bonded
    Composite
    Meltblown
    Needlepunch
    Nanotechnology
    Spunbond
    Spunlace
    Thermal Bonded
    Wetlaid

    Armbrust American Adds Meltblown Manufacturing

    Radici Adds Meltblown Line

    Biosphere Corporation: Expands into Baby Diaper Production in Ukraine

    Nonwovens Industry’s Top 10 Breaking News Stories of 2020

    Jacob Holm to Expand Spunlace Capacity in Candler
    China
    Eastern Europe/Russia
    India
    Middle East/North Africa
    North America
    Pacific Rim
    South/Central America
    Turkey
    Western Europe

    Shemesh Adds U.S. Headquarters

    Domtar Sells Personal Care Unit

    Jacob Holm to Expand Spunlace Capacity in Candler

    Nice-Pak to Construct New Facility in Mooresville, IN

    United Sewing Automation Produces U.S.-Sourced and Manufactured PPE Face Masks
    Associations
    Contracts / Awards
    Education
    Facilities / Capacity
    Green / Sustainability
    Legal / Regulatory
    Market Data
    Mergers and Acquisitions
    Product Improvement / Innovation
    R&D/Basic Research
    Shows / Events

    Armbrust American Adds Meltblown Manufacturing

    Techtextil, Texprocess Postponed to 2022

    Shemesh Adds U.S. Headquarters

    Domtar Sells Personal Care Unit

    Record Mask Production from BelEmsa
    Chart
    Companies
    All Companies
    Categories
    Company Profiles
    Add New Company
    International Buyers Guide Companies
    Alliance Machine and Engraving

    Fagus GreCon, Inc

    Investkonsult Sweden AB

    Top Polymer Enterprise, LLC

    Omya International AG
    Brands
    Brand Owners
    • Magazine
      • Current / Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Edition
      • Southeast Asia Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
    • Breaking News
    • Buyers Guide
      • All Companies
      • Categories
      • Company Profiles
      • Add Your Company
    • Applications
      • Absorbent Core
      • Adult Incontinence
      • Antimicrobials
      • Apparel
      • Automotive and Transportation
      • Chemicals / Adhesives
      • Construction
      • Contract Services
      • Diaper, Baby
      • Electronics
      • Feminine Hygiene
      • Fibers
      • Filtration
      • Flame Retardance
      • Geotextile / Agrotextile
      • Home Products
      • Hygiene Film/Components
      • Industrial / Institutional
      • Inspection / Quality Control
      • Machinery and Equipment
      • Medical
      • Wipes
    • Technology
      • Air Through Bonding
      • Airlaid
      • Carded/Carding
      • Chemical Bonded
      • Composite
      • Meltblown
      • Needlepunch
      • Nanotechnology
      • Spunbond
      • Spunlace
      • Thermal Bonded
      • Wetlaid
    • Market
      • China
      • Eastern Europe/Russia
      • India
      • Middle East/North Africa
      • North America
      • Pacific Rim
      • South/Central America
      • Turkey
      • Western Europe
    • Other
      • Associations
      • Contracts / Awards
      • Education
      • Facilities / Capacity
      • Green / Sustainability
      • Legal / Regulatory
      • Market Data
      • Mergers and Acquisitions
      • Product Improvement / Innovation
      • R&D/Basic Research
      • Shows / Events
    • Top 40 Companies
      • Chart
      • Companies
    • Online Exclusives
    • Hygiene Directory
      • Brands
      • Brand Owners
    • Slideshows
    • Experts Opinions
    • Videos
    • Podcasts
    • Infographics
    • Whitepapers
    • Jobs
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
      • Live From Asian Connections
    • Resources
      • Suppliers Gallery
      • Literature Showcase
      • Web Showcase
      • Home Page Showcase
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Capitol Comments

    FDA Seeks Comment on Labeling Requirements for Nonwoven Medical Devices

    Agency seeking knowledge on whether new regulations are a burden.

    Related CONTENT
    • Record Mask Production from BelEmsa
    • 3M Offers Next Generation Silicone Adhesives
    • HanesBrands Surgical Face Mask Receives Authorization by U.S. FDA
    • UPenn Grads Use Nonwovens to Develop First Flushable Pregnancy Test
    • Muumi Baby
    Peter G. Mayberry02.02.18
    Every once in a while, an opportunity comes along for the industry to inform the U.S. government about the impact certain regulations have on industry operations; this is one of those opportunities. In this case, it involves compliance reporting with U.S. Food and Drug Administration (FDA) requirements that single-use medical devices (SUD) be “prominently and conspicuously” labeled to identify the SUD manufacturer. 

    FDA is calling for industry comment on whether these reporting requirements are a burden and whether changes should be made to existing regulations. FDA even invites comment on the need for these regulations outright and questions if the reporting requirements should be done away with altogether.

    The issue grows out of sections from the U.S. Food Drug and Cosmetic Act (FDCA) – Federal law overseen by FDA for selling medical devices to the U.S. market – among other things. 

    Sections of the FDCA cover a litany of medical devices made from nonwovens including, among others (some incredibly complex): surgical drapes/gowns, personal protective devices, wound care products, absorbent pads intended for medical use, tampons, adult incontinent devices—it’s a long list. 

    Contained in the FDCA (21 USC 352) are labeling requirements that medical device manufacturers and distributors must meet to prevent the device from being withdrawn from market, or suffering lesser regulatory action, because it is “misbranded.” 

    The law requires devices (new and reprocessed) to be “prominently and conspicuously” labeled with the “name of the manufacturer, a generally recognized abbreviation of such name or a unique and generally recognized symbol identifying the manufacturer.”

    When it comes to medical devices manufactured from nonwovens, these labeling requirements fall primarily on manufacturers/distributors of single-use devices, but there are provisions that also apply should an SUD be reprocessed for reuse.

    According to FDA, these requirements impose a “minimal burden” on industry because the FDCA “only requires the manufacturer, packer or distributor of a device to include their name and address on the labeling of a device. This information is readily available to the establishment and easily supplied.” 

    Nevertheless, FDA invites comments on the following topics:

    1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;
    2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
    3) ways to enhance the quality, utility, and clarity of the information to be collected; and
    4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate and other forms of information technology.

    As for Topic 2, FDA estimates current regulatory requirements regarding labels that require the identification of manufacturers for SUD products – based on registration and premarket submission databases – translate to about six minutes per device per year.

    That’s six minutes.  Per device.  Per year.  

    Sounds about right?  Then here’s an opportunity to agree with FDA in public comment. 

    Or is it more like six minutes! Are you kidding me? Then this is an opportunity to tell that to FDA too. Perhaps best of all, it’s an opportunity to call for changes – or even repeal – of the reporting requirements if that’s what is needed. 

    Whichever way, all comments – written or electronic – are due before midnight (Eastern time), February 20. All submitted comments must reference Docket Number FDA-2011-N-0672 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices.”

    Electronic comments must be filed using www.regulations.gov, and written comments can be sent via mail, hand delivery or courier. Regulations.gov will accept and publish all comments received by the deadline. Written comments will be considered timely if postmarked or delivered on or before the February deadline. Written comments will also be published, in full, on regulations.gov. 

    Written comments should be directed to Dockets Management Staff (HFA-305), U.S. Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    More information: Amber Sanford, FDA’s Office of Operations; 301-796-8867;  PRAStaff@fda.hhs.gov.


    Judge Rules DC Can’t Prosecute K-C for Flushable Wipes Claim
    A Federal judge has temporarily barred the District of Columbia from enforcing part of a city-passed law that requires special labeling for “flushable” wipes. In the court case – brought by Kimberly-Clark – Judge James Boasberg issued a preliminary injunction that prevents the D.C. government from enforcing city-enacted labeling requirements for “flushable” wipes as they apply to K-C products. The decision was based on K-C’s First Amendment rights to corporate free speech. 

    D.C.’s newish law, which was enacted in late 2016 and, technically, took effect on January 1 of this year, can still be applied to other companies that offer “flushable” wipes for sale in the District. But that’s not likely until the city agrees to an underlying standard – as required by the same law – for making a “flushable” claim. 

    Meanwhile, Walmart private-label Equate wipes – prominently-labeled “Flushable” – are being offered for sale in D.C. These wipes also carry a labeled disclaimer referencing INDA standards, alone, as basis for flushable claims. This despite the fact that INDA-developed flushability standards have repeatedly been rejected by municipal waste water operations internationally. 
    Related Searches
    • technology
    • tampons
    • food
    • industry
    Related Knowledge Center
    • Legal/Regulatory
    Suggested For You
    Record Mask Production from BelEmsa Record Mask Production from BelEmsa
    3M Offers Next Generation Silicone Adhesives 3M Offers Next Generation Silicone Adhesives
    HanesBrands Surgical Face Mask Receives Authorization by U.S. FDA HanesBrands Surgical Face Mask Receives Authorization by U.S. FDA
    UPenn Grads Use Nonwovens to Develop First Flushable Pregnancy Test UPenn Grads Use Nonwovens to Develop First Flushable Pregnancy Test
    Muumi Baby Muumi Baby
    Innovation is Alive and Well in Private Label Innovation is Alive and Well in Private Label
    Focus on: Hygiene Components Focus on: Hygiene Components
    Flushable Pregnancy Test Earns FDA Clearance Flushable Pregnancy Test Earns FDA Clearance
    Jet.com Launches Private Label Brand Jet.com Launches Private Label Brand
    2017 Converting and Contract Manufacturing Review 2017 Converting and Contract Manufacturing Review
    Walmart Adds Premium Diaper to Store Brand Walmart Adds Premium Diaper to Store Brand
    NDBN, Huggies Release Study on Diaper Need NDBN, Huggies Release Study on Diaper Need
    Focus On: Regulated Wipes Focus On: Regulated Wipes
    Montalvo Makes New Hire Montalvo Makes New Hire

    Related Capitol Comments

    • Legal/Regulatory | North America

      TRUMP’S TRADE WARS: Battling on Multiple Fronts

      New administration policy’s are shaking up global industry.
      Dawnee Giammittorio, Associate Director at The Franken Group 07.06.18

    • Legal/Regulatory | North America
      Commerce Secretary Outlines Trump Administration Policies of Interest to the Nonwovens Industry

      Commerce Secretary Outlines Trump Administration Policies of Interest to the Nonwovens Industry

      Ross discusses NAFTA renegotiation, U.S. trade relations and domestic workforce issues.
      Peter G. Mayberry 10.09.17

    • Legal/Regulatory
      Data Show U.S. Imported More Nonwoven Roll Goods Last Year than it Exported

      Data Show U.S. Imported More Nonwoven Roll Goods Last Year than it Exported

      USITC reports that U.S. exports have fallen roughly 4%
      Peter G. Mayberry 09.11.17


    • Legal/Regulatory

      With U.S. Withdrawal from TPP, Japan and Europe embark on “Colossal Trade Deal”

      World nations race to fill void in international trade issues left by exit
      Peter G. Mayberry 07.31.17

    • Legal/Regulatory | North America

      USTR Outlines Goals for NAFTA Renegotiation and Calls for Public Comment

      Any change to trade deal could have major implications for nonwovens industry.
      Peter G. Mayberry, Contributing Editor 07.10.17

    • Legal/Regulatory

      White House Issues Executive Orders on Trade Agreement Violations and New Office for Trade and Manuf

      Trump administration is better poised to identify trade abuse than its predecessors.
      Peter G. Mayberry, Contributing Editor 05.31.17


    • Legal/Regulatory | North America | Wipes

      DC Approves Flushable/Non-Flushable Labeling Requirements for Consumer Nonwovens

      If approved, bill will be first of its kind in the U.S.
      Peter G. Mayberry 01.02.17

    • Legal/Regulatory

      Recent Action on EPA Emission Standards for Industrial Boilers

      25,000 existing facilities could be affected by change.
      Peter G. Mayberry 11.07.16

    • Fibers | Legal/Regulatory

      Residential Insulation Under Review at the Federal Trade Commission:

      Public Comments on FTC’s R-Value Rule Now Being Accepted
      Peter Mayberry, contributing editor 05.13.16


    • Apparel | Education | Legal/Regulatory | Medical | North America

      FDA Issues Guidance Document on Gowns Used in Healthcare Settings

      Webinar will provide both manufacturers and users of terms used to describe the protective availability of gowns
      Peter Mayberry, contributor 01.05.16

    • Antimicrobials | Feminine Hygiene | Legal/Regulatory

      FDA Guidance Eases Regulatory Burdens on Certain Nonwovens

      surgical gowns, adult diapers, fem hy pads are among the nonwovens impacted by measure
      Peter Mayberry, contributing editor 10.13.15

    • Construction | Legal/Regulatory | North America

      NIOSH Calls for Innovation in Personal Protective Equipment for Healthcare Workers

      Can nonwovens come to the rescue?
      Peter Mayberry, contributing editor 08.03.15


    • Filtration | Legal/Regulatory | Nanotechnology

      Proposed Rule could have a Big Impact on Nanoscale Chemicals used in Nonwovens

      EPA Proposes TSCA Reporting/Recordkeeping Requirements
      Peter Mayberry 05.05.15

    • Construction | Legal/Regulatory

      New Mandatory Standard and Testing Requirements for Frame Child Carriers Now in Place

      two million frame child carriers currently exist in U.S. households.
      Peter Mayberrry, contributing writer 04.07.15

    • Filtration | Legal/Regulatory

      EPA Updates Compliance Model for Radionuclide Emissions

      Nonwoven Filtration Media Potentially Im
      Peter Mayberry, contributor 03.09.15

    Trending
    • Techtextil, Texprocess Postponed To 2022
    • Essity Launches Reusable Underwear Product
    • Armbrust American Adds Meltblown Manufacturing
    • Lemu Group Building Surgical Mask Production Line
    • Domtar Sells Personal Care Unit
    Breaking News
    • Freudenberg to Establish Apparel Interlining Competence Centers
    • Minet Adds Spunlace Line in Romania
    • Lemu Group Engineers Mask-Making Machine
    • Armbrust American Adds Meltblown Manufacturing
    • P&G Reports 8% Sales Increase
    View Breaking News >
    CURRENT ISSUE

    January 2021

    • Biosphere Corporation: Expands into Baby Diaper Production in Ukraine
    • Trends in Diapers: Sustainability, Natural Ingredients or Other Features?
    • Baby Diapers A Changing Market
    • Ultrasonics for Nonwovens
    • Hygiene Machinery Review
    • The Private Label Market
    • View More >



    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    NIH Study Compares Low-Fat, Plant-based to Low-Carb, Animal-Based Diet
    Gadot Positions Mineral Line for Vegan Market
    Nutritfy India to Launch Global Broadcast Channel Covering Nutrition
    Coatings World

    Latest Breaking News From Coatings World

    LINE-X Launches Dealer Program with International Truck
    Engaging Programs Secure Top Employer Status for AkzoNobel
    PPG Reports Q4, Full-year 2020 Financial Results
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Cretex Companies CEO Steps Down
    Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread
    Endoscopic Hemostasis Devices Market Valued at $730 Million
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Pfizer, BioNTech Enter Vax Pact with COVAX
    FDA Approves Janssen’s CABENUVA
    AGC Biologics Appoints Boulder Site GM
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Weekly Recap: JLo Beauty Launches, Unilever Partners with Alibaba, Estée Lauder Appoints SVP & More
    Coty Appoints Chief Procurement Officer
    Lageen Tubes Launches Mono-Material PE Tube Solutions
    Happi

    Latest Breaking News From Happi

    Carol’s Daughter Adds New Hair Products
    Moroccan Gold Series Launches NuDo Shampoo
    Youbody Debuts Waterless Body Wash
    Ink World

    Latest Breaking News From Ink World

    BOBST Demonstrates Future of Flexible Packaging Production at Virtual Open House
    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    AR Packaging Acquiring Firstan Holdings Ltd
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Gallus planning virtual event for March
    Lemu Group engineers mask-making machine
    Niagara Label upgrades with Nilpeter flexo press
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Freudenberg to Establish Apparel Interlining Competence Centers
    Minet Adds Spunlace Line in Romania
    Lemu Group Engineers Mask-Making Machine
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Cretex Companies CEO Steps Down
    Conformis Enters Development & Supply Agreement with SITES Medical
    Sectra, RSA Biomedical Sign Distribution Agreement for Implant Stability Tool
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    UDC Subsidiary Adesis' Website Wins 2020 MarCom Platinum Award
    Ambiq Wins IoT Semiconductor Company of the Year Award
    Ynvisible Names Michael Robinson CEO, Jani-Mikael Kuusisto SVP Ventures

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login