October 20, 2016 by David Lennarz
Filed under: Medical Devices |
On October 14, 2016, the U.S. Food and Drug Administration (FDA) announced a proposed rule that would require device manufacturers to submit labels and package inserts to FDA electronically when listing Class II and Class III home-use devices. The rule would allow manufacturers to submit labels and package inserts for Class I or other excluded home-use devices voluntarily.
FDA defines a home-use device as “a medical device intended for users in any environment outside of a professional healthcare facility.” These devices are intended for use in homes and healthcare facilities where:
- A user is a patient (care recipient), caregiver, or family member that directly uses the device or provides assistance in using the device.
- A qualified healthcare professional is a licensed or non-licensed healthcare professional with proficient skill and experience with the use of the device so that they can aid or train care recipients and caregivers to use and maintain the device.
Some examples of class II home-use devices include powered wheelchairs as well as certain pregnancy test kits. Examples of class III home-use devices include implantable pacemakers and replaceable heart valves.
According to FDA, the proposed rule would “better allow manufacturers to provide such facilities with information that is more robust, up-to-date, and user-friendly.” Once finalized, FDA has plans to make the device labeling information public through an FDA-managed or partner website. If finalized, manufacturers of class II and class III home-use devices would have to begin submitting labeling information 90 days after the publication of the final rule.
FDA opened this proposed rule for comments on October 17, 2016 for a 90-day period. Interested parties may submit electronic comments at www.regulations.gov. Enter docket number FDA-2016-N-2491 in the search box. FDA will review all comments before the release of the final rule, expected January 17, 2017.
Registrar Corp is a U.S. FDA consulting firm that helps businesses comply with FDA regulations for medical devices, including labeling requirements. You can reach Registrar Corp by phone at +1-757-224-0177 or our Regulatory Advisors are available 24-hours a day online at www.registrarcorp.com/livehelp.
October 3, 2016 by David Lennarz
Filed under: FDA News |
On September 28, 2016, the U.S. Food and Drug Administration (FDA) opened the term “healthy” to public comment through a “request for information.” The agency’s goal is to promote the development of healthier foods and to assist consumers in making food choices that are consistent with current public health recommendations. Food manufactures may continue using the term “healthy” as long as they meet the current regulatory guidelines during the comment period.
Examples of questions FDA hopes to have answered during the comment period include “What should healthy mean from a nutrition perspective?” and “How do consumers view the word healthy?” Interested parties can find information for submitting written and electronic comments here. In addition to allowing industry to submit written comments, FDA plans to host public forums to receive further feedback.
FDA’s request for information on the term was sparked in part by a citizen petition filed by KIND LLC in December 2015 after receiving a warning letter for using the term “healthy” on some of its product labels. In its petition, KIND urged FDA to update its definition of “healthy” to be consistent with evolving information on overall nutrition quality rather than specific nutrient levels. For example, foods like almonds, avocados, and salmon are too high in fat to meet FDA’s current regulations for “healthy,” but are recognized as having a valuable place in a healthy diet.
Until FDA lands on a final definition for “healthy,” the agency is using enforcement discretion to allow certain foods that don’t meet the agency’s current requirements to bear the content claim “healthy.” According to a guidance document recently published by FDA, it has no intention to “enforce the regulatory requirements for products that use the term if certain criteria described in the guidance document are met.” The criteria outlined in the guidance document apply to foods that:
- Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or
- Contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.
Registrar Corp stays up-to-date on U.S. FDA food labeling regulations and will continue to update industry as FDA’s decision on redefining “healthy” unfolds. Please feel free to contact us with any questions regarding U.S. FDA requirements for using certain claims or other FDA labeling regulations, including the recently finalized changes to the Nutrition Facts Chart. You can reach Registrar Corp by phone at +1-757-224-0177 or our Regulatory Advisors are available 24-hours a day online at www.registrarcorp.com/livehelp.
September 22, 2016 by David Lennarz
Filed under: Food & Beverages, FSMA |
The U.S. Food and Drug Administration (FDA) recently suspended the food facility registration of SM Fish Corp, located in Far Rockaway, NY, following a failed re-inspection and re-sampling of their ready–to-eat (RTE) seafood products. An initial inspection of the facility from June 14, 2016 to July 6, 2016 revealed that several environmental samples tested positive for Listeria. FDA requested that SM Fish Corp. recall some of its RTE products and shut down briefly to revise its cleaning and sanitation procedures, to which the facility agreed.
Following the initial inspection SCORE, a decision making body of individuals intended to ”ensure the agency engages in an integrated approach to identifying timely and efficient measures in order to help mitigate public health risks,” requested a re-inspection of SM Fish Corp. in order to ensure the problems found at the facility were resolved.
The decision to suspend the facility’s registration was made under the authority of the 2011 Food Safety Modernization Act (FMSA) after FDA’s re-inspection in August 2016 revealed a continued widespread Listeria contamination within the facility. As a result of this suspension, SM Fish Corp. is banned from marketing food in the United States. FDA may lift the suspension only when the agency determines the facility’s food no longer has reasonable probability of posing serious health issues or death to human consumers.
Facilities are often unaware of the cost and time associated with FDA re-inspections. When FDA initially inspects a food facility, it is financed by the agency, but if FDA finds reason to re-inspect, the agency may charge re-inspections fees. For facility re-inspection fees, FDA will invoice the responsible party for the direct hours; including time spent preparing and traveling, at the appropriate hourly rate. The FY 2017 hourly rates for FDA re-inspections are as follows:
- $221 per hour for domestic facilities
- $285 per hour when foreign travel is required
It is crucial to prepare for possible FDA inspections in order to prevent costly re-inspections that may lead to the suspension of your food facility registration. Registrar Corp can assist facilities preparing for FDA inspections. A Food Safety Specialist can perform mock FDA inspections at the request of both foreign and domestic facilities to help identify any potential problems and help facilities to better understand FDA’s expectations. Additionally, if your foreign food facility utilizes Registrar Corp as its U.S. Agent, Registrar Corp will perform a mock inspection free of charge (other than travel and lodging expenses) when FDA issues a Notice of Inspection for that facility.
For more information or assistance regarding FDA inspections, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.
September 13, 2016 by David Lennarz
Filed under: FDA News, Registrar Corp |
Registrar Corp writes to remind the food industry of an important upcoming regulatory deadline. Under the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), food facilities that manufacture, process, pack, or store food for distribution in the United States are required to renew their FDA registrations between October 1 and December 31, 2016.
Food facilities have been required to register with FDA since 2003. FSMA updated this requirement in 2011 to include biennial renewals in order to keep FDA’s registration database up-to-date. Food facilities are now required to renew every even numbered year between October 1 and December 31.
FDA’s Registration Renewal requirement applies to both domestic and foreign food facilities registered with FDA. Foreign facilities must also designate a U.S Agent for FDA Communications in Section 7 of their renewal. It’s important to designate a professional knowledgeable on FDA regulations , as this U.S. Agent will have access to information submitted in the facility’s registration and may speak on behalf of the facility to FDA regarding inspections, shipments, and other regulatory matters.
Facilities must renew their FDA registration no matter when they submitted their initial registration. A facility could have registered with FDA one month or even one day before October 1, and the facility would still need to renew. If a facility does not renew its registration by December 31, FDA will consider the registration to be expired. Distributing food in the United States with an expired registration is a prohibited act and may lead to detention of products or other regulatory action by FDA.
There was a 14% decrease in the number of food facilities registered with FDA from January 2014 to January 2015. Registrar Corp believes the drop was due to facilities failing to renew their registration during the 2014 renewal period.
Registration renewals may be completed directly with FDA by mail, fax, or online, or facilities may authorize a third party individual to complete their renewal.
Registrar Corp is a U.S. FDA consulting firm that helps food facilities comply with FDA regulations, including registration, U.S. Agent requirements, food labeling, and new requirements under the Food Safety Modernization Act. Registrar Corp’s Regulatory Specialists register and renew thousands of food facilities each year and act as the U.S. Agent for over 13,000 facilities around the world. Contact Registrar Corp for assistance.
This article was originally published as a press release.
September 9, 2016 by David Lennarz
Filed under: FDA News |
On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule on the effectiveness and safety of over-the-counter (OTC) antibacterial soaps. This final rule affects consumer antiseptic wash products for both hands and body which contain the frequently used ingredients triclosan and triclocarban as well as 17 other active ingredients (See 81 FR 61110 for a full list of eligible ingredients). Beginning September 6, 2017, companies that manufacture and market affected antibacterial soaps may not legally introduce or deliver for introduction their products into interstate commerce unless approved under a new drug application.
FDA first proposed this rule in 2013 after research suggested that long-term use and exposure to specific active ingredients used in antibacterial soaps may cause a health risk to consumers. Examples of these health risks include hormonal effects and bacterial resistance. According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), “Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water.”
FDA has postponed a rule making decision for consumer antiseptic soaps and washes that contain the ingredients- benzalkonium chloride, benzethonium chloride, and cloroxylenol (PCMX) for one year to allow industry to provide additional safety information. FDA will take regulatory action at that time, dependent upon whether the data provided by industry supports the conclusion that those active ingredients are generally recognized as safe and effective for this intended use.
FDA’s final rule only applies to consumer rinse-off antibacterial soaps. This final rule does not affect consumer no-rinse handnitizers or antibacterial products used in hospital or health care settings.
Registrar Corp can help manufacturers determine whether their product is affected by FDA’s final rule. For questions or assistance with the compliance of the final rule on antibacterial soaps, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.come/livehelp.
Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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