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are labeling requirements that medical device manufacturers and distributors must meet to prevent the device from being withdrawn from market, or suffering lesser regulatory action, because it is “misbranded.”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.
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.
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.
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.
