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EUA FDA Transition Plan for Medical Devices in 2022

In response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations (EUA). This measure by the FDA was designed to mitigate the stress on the device supply chain and the associated scarcity of certain devices that are critical to the prevention and management of Covid-19. So far, FDA through the EUA and enforcement priority pathways issued approximately 450 devices EUAs and 17 medical device enforcement policies. Most of the devices receiving EUAs are in vitro diagnostic tests for COVID-19.

Given the magnitude of the COVID-19 pandemic, FDA recognizes that it will take time for device manufacturers, healthcare facilities, healthcare providers, patients, and consumers to adjust to the policies adopted and operations implemented during the declared COVID-19 public health emergency to someday resume normal regulatory operations. Therefore, FDA has developed and issued new draft guidance detailing phased transition plans for devices granted EUA designations as well as devices that fall within the enforcement policies issued during COVID-19. The Medical devices EUA transition guidance document provides more clarity on how device manufacturers whose devices were made available via pandemic-era EUAs will be affected once the public health emergency abates.

Time-limited EUA

The EUA declaration is temporary and can be terminated. When such happens, all EUAs issued under that declaration also terminate. Therefore, all EUA designations now in place for medical devices that are yet to obtain 510(k) clearance or other market registration from FDA would expire once the COVID-19 emergency is over. Once a device’s EUA designation expires, full US market registration is required to keep that device on the US market.

FDA Transition Plans for EUA Devices

  • FDA will provide advance notice of termination for each EUA in the US Federal Register 180 days before the final termination day.
  • FDA will not object to the continued distribution of devices within the scope of the guidance after the EUA termination date where:
    • The manufacturer has submitted a marketing submission to FDA and had it accepted by

FDA before the EUA termination date; and

  • FDA has not taken a final action on the marketing submission.
  • From the time between advance notice and termination date, manufacturers must continue to comply with the obligations under the respective EUA.
  • FDA recommends that manufacturers of specific reusable, life-supporting, and life-sustaining devices submit reports to the agency for the evaluation of potential product shortages post-EUA termination.
  • After the termination date, the manufacturer must follow the proper channels laid out in the guidance or discontinue manufacturing.

Are you Not interested in full FDA registration after EUA termination?

FDA generally will not request market removal of already distributed devices if they are:

1) Single-use, non-life-supporting/non-life-sustaining devices (e.g., face masks) and will be consumed by the end-user.

2) Reusable, non-life-supporting/non-life-sustaining devices (e.g., remote patient monitoring devices) provided the manufacturer either restores these devices to the previously FDA-cleared or approved version or ensures publicly available labeling that accurately describes the product features and regulatory status (i.e., that the product lacks FDA clearance or approval).

3) Reusable life-supporting/life-sustaining devices (e.g., ventilators, extracorporeal membrane oxygenation systems, continuous renal replacement therapy systems) again under the same conditions that the manufacturer either restores the devices to the previously FDA-cleared or approved version of the device or ensures publicly available labeling that accurately describes the product features and regulatory status (i.e., that the product lacks FDA clearance or approval).

4) In vitro diagnostic devices to be used for no more than 2 years after the EUA termination date or until the expiration date, whichever is less.

FDA Transition Plan for Devices Within Enforcement Policies

There is a 180-day transition period, consisting of three phases, starting on a yet-to-be-determined implementation date of the transition plan. If the transition plan is finalized before the termination of the PHE, the implementation date will be the date the PHE ends. If the PHE ends before the finalization of the transition plan, the implementation date will be at least 45 days after the transition plan is finalized.

Phase 1 begins on the implementation date, and manufacturers must follow the adverse event reporting requirements in 21 CFR Part 803.

Phase 2 begins 90 days after the implementation date, and manufacturers are expected to adhere to the reporting requirements for device corrections and removals in 21 CFR Part 806 in addition to meeting the requirements in Part 803. In addition, manufacturers must also register their facilities (if not already registered) and list the product consistent with 21 CFR Part 807 Subparts B-D.

Phase 3 begins 180 days after the implementation date. FDA plans to withdraw the specific Enforcement Policies as indicated in the guidance document and manufacturers will be expected to comply with all statutory and regulatory requirements applicable to their devices (e.g., 21 CFR Part 820, 21 CFR Part 801 Subpart B, and 21 CFR Part 830)

Manufacturers are strongly encouraged to work to complete submissions well in advance of the start of Phase 3 to avoid potential delays created by a large influx of new submissions and to best serve public health. FDA will expect the removal of all devices unless a marketing submission has been submitted and accepted by FDA before the start of Phase 3.  FDA has not taken a final action on the marketing submission.

How Quality Smart Solutions can help

How can Quality Smart Solutions help you regarding the EUA medical device transitioning? We offer medical device license application services that consist of preparing and submitting applications, as well as handling communication with the FDA. Our team of experts can handle all medical licensing matters and are happy to help you with future projects or questions! Please find our contact information here:

Contact our Compliance Experts to Discuss Your Needs (qualitysmartsolutions.com)

30 Minutes Free Consultation

Resources:

Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transition-plan-medical-devices-issued-emergency-use-authorizations-euas-during-coronavirus-disease?utm_medium=email&utm_source=govdelivery

Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transition-plan-medical-devices-fall-within-enforcement-policies-issued-during-coronavirus-disease

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Top 6 Questions to ask about OTC Drugs

1. What are over-the-counter drug products (OTC drugs)?

Non-prescription drugs also called over-the-counter (OTC drugs), are health products that can be bought without a doctor’s prescription. OTC drugs can include things like hand sanitizer, sunscreens, cold & flu medication, and medicated topical products such as skin treatments, lip ointment, and anti-fungal creams.

2. What licensing is required for OTC drugs?

Non-prescription drugs require a valid Drug Identification Number (DIN) to be sold in Canada. On a product label, this number indicates the drug has met our requirements for safety, quality, and effectiveness.

Furthermore, Canadian companies that manufacture, package, label, and import OTC drugs must:

A DEL is provided after a satisfactory inspection.

3. What is a DIN and how does it apply to OTC drugs?

A Drug Identification Number (DIN) is an eight-digit number that is assigned by Health Canada to OTC drugs prior to them being marketed in Canada. The DIN is a unique number that identifies all drug products sold in a dosage form in Canada. The DIN is located on the label of prescription and OTC drugs that have been evaluated and authorized for sale in Canada.

4. Can a product classified as an OTC drug be sold without a DIN?

If a product defined as a drug under the Food and Drugs Act is sold without a DIN, it is not in compliance with Canadian law, and regulatory action will be taken.

Looking for assistance with securing DIN numbers for your OTC drugs?

5. How do I obtain a DIN for my OTC drugs?

To obtain a DIN for your OTC drugs, a DIN submission must be filed with Health Canada. Prior to issuing DINs, Health Canada’s Drugs Directorate requires the submission of sufficient data to evaluate the safety and efficacy of a drug for its intended use. A submission for a DIN should contain the following information for review:

  • a completed Drug Submission Application, including proposed Canadian labels and prescribing information or a package insert where applicable
  • a completed DIN Submission Certification or Category IV Drug Submission Certification as appropriate
  • specific product type information as requested by Health Canada

6. How long does it take to get a DIN for my OTC drugs?

Health Canada offers the following service standards for DIN submissions:

  • DIN-A – Drug Identification Number Application (Labelling Only) – 180 days
  • DIN-A – Drug Identification Number Application (Labelling Standard) – 45 days
  • DIN-D – Disinfectant Drug Identification Number Application (Non-Clinical/Clinical Only) – 210 days
  • DIN-D – Disinfectant Drug Identification Number Application (Labelling Only) – 180 days
  • DIN-D – Disinfectant Drug Identification Number Application (Labelling Standard) – 45 days
  • DIN-F – Category IV Monograph Drug Identification Number Application (Labelling Standard) – 45 days

How Quality Smart Solutions can help

Our Experts at Quality Smart Solutions are here to help and offer any drug-related regulatory advice and support on successfully securing your DIN, responding to potential information requests, keeping your license updated, and reviewing your drug labels. Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: 

30 Minutes Free Consultation
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Learn how to differentiate Dietary Supplement vs NHP Labeling

Introduction

Dietary supplements in the USA are very similar to natural health products (NHP regulations) in Canada and many products can be classified as both. But not all dietary supplements are natural health products and vice-versa. There are some distinct classification factors for each. Generally, dietary supplements are labeled comparably to food products in the USA. Whereas natural health products are labeled more like drug products in Canada. This blog will provide an overview of some labeling requirements for both NHPs and dietary supplements, to compare the two product types.

Principal Display Panel Aka the Front Panel

Dietary Supplements – Must list a statement of identity and net quantity on the front panel.

Natural Health Products – Must list primary brand name, Natural Product Number (NPN label requirements), the net amount of product, specify if the product is sterile and if not already apparent, list the dosage form.

Nutrition Facts and Ingredients Listing

Dietary Supplements Labeling – Dietary Supplements must list a Supplement Facts panel hosting all nutritional information including daily value as well as the list of active ingredients. The listing of ingredients should be in descending order by weight.

Natural Health Products labeling– To best align with the regulations for Natural Health Products, we recommend a line listing for each of your medicinal ingredients. This would list common name and proper name, source material, label claim amount, extract information, and any potencies. Also, a list of all other ingredients preceded by a title of “non-medicinal ingredients” must be included.

Health Claims

Need help bringing your dietary supplement or NHP labels into compliance?

Dietary Supplements – All health claims should be structure-function based. Claims can be notified/approved for use through the FDA’s dietary supplement notification process. Many allowable claims can be found online through FDA resources and are like food claims in that way. We recommend the product owner hold a dossier of research to support the safety of the product and efficacy for any health claim made on a supplement label. We recommend you only use approved claims on product labels.

Natural Health Products – All health claims published on natural health product labeling must be in accordance with your product license. These come from Health Canada monographs or the class 3 application process where additional research can be submitted to support the efficacy of the product or an ingredient. We recommend you only use approved claims on product labels.

Caution and Risk Statements

Dietary Supplements – The general FDA caution statement must be listed when a structure/function claim is used. Other caution statements are voluntary to protect the consumer and certain subpopulations.

Natural Health Products – All risk statements for natural health product labeling must be as per your product license. These may come from Health Canada published monographs or through the class 3 application process where they can be added voluntarily or by the regulator.

Company Information

Dietary Supplements – For dietary supplement labeling, you must list the name and place of business for the manufacturer, packer, or distributor. You must list the street address if the company is not listed in a city directory or telephone book.

Natural Health Products – For natural health product NHP labeling you must list the name and address of the product license holder. You must also list the name and address of the importer if the product is made outside of Canada.

Other Information/Tips

Dietary Supplements – These products must specify on the front panel that they are dietary supplements. Font size for dietary supplements is 1/16 inch in height as measured by lowercase ‘o’. You may not place any non-required label content between required label content, this is known as intervening material.

Natural Health Products – All required content that is pertinent to the consumer must be printed in both official languages, English and French. Font size for natural health products is such that the average consumer can read the label (is legible). No minimum font sizes are prescribed/limited at this time.

Summary

In conclusion, there are many differences and similarities between natural health products and dietary supplement labels, most of which are apparent if you were to hold the two side by side. It would be difficult to prepare a label that is acceptable for both Canadian and US requirements, as each label type has its own intricacies. We recommend having separate labels for these markets based on many of the above requirements.

Please reach out to our team of specialists to further discuss your dietary supplements or natural health products. We are happy to help discuss the classification, labeling, and registration for your products in North America!

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5 Tips on How to Complete Your Cosmetic Notification Form

What is a Cosmetic?

Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance or mixture of substances manufactured, sold or represented for use in cleaning, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.” This is different than drugs and natural health products even though they are all regulated under the Food and Drug Act. The classification of the product depends on its function, purpose, and representation for use (such as claims or recommended purposes). Ingredients in the formula may also help determine the classification. For example, in Canada, ingredients like corticosteroids can only be licensed as drugs whereas Green Tea Leaf Extract may be licensed as a cosmetic product or a natural health product.

Types of Cosmetic Notification Form

This form can be used for new products, amendments, and discontinuation of sales. For new products, you must notify Health Canada within 10 days after you first sell the cosmetic product in Canada. For amendments, you must notify Health Canada of this within 10 days of the change and include the Cosmetic Number in the notification form. For discontinuation of sale, you must notify Health Canada of this within 10 days of the discontinuation and include the Cosmetic Number in the notification form. This notification form must be completed and submitted at the latest 10 days after it is first sold in Canada.

Cosmetic Notification Form

In Canada, it is the Food and Drugs Act and Cosmetics Regulations that require a Cosmetic Notification Form to be submitted by the manufacturer or importer for all cosmetic products. This notification form must be completed and submitted at the latest 10 days after it is first sold in Canada. This form is also used for amendments and discontinuation of sales. This form must include the following information:

  • Name and address of the manufacturer of the cosmetic product
  • Name of the cosmetic product
  • Function of the cosmetic product (i.e. moisturizer, shampoo, conditioner)
  • Ingredient list that includes each ingredient’s name and its concentration percentage or concentration range
  • Form of the cosmetic product (i.e. foam, liquid oil, semi-solid lotion)
  • Name and address Canadian manufacturer, importer or distributor
  • Name and address of individual who manufactures or formulates the cosmetic product
  • Name and title of individual who signs the notification form

Looking for assistance with submitting your Cosmetic Notifications to Health Canada?

Tips on How to Complete a Cosmetic Notification Form

To complete the Cosmetic Notification Form efficiently, it is recommended to:

  • Have a complete list of ingredients ready, including composition information of the formula
  • Have a copy of the bilingual product label prepared
  • Know who your manufacturer/importer/distributor is and have their contact information on file
  • Work with a third-party consulting firm like Quality Smart Solutions, that is familiar with the Canadian Cosmetics Regulations. This way you can have your cosmetic formulas and labels reviewed before submission to minimize any pushback from Health Canada
  • Have a copy of the previously submitted notification form and cosmetic number ready if this is an amendment or discontinuation of sale

How Quality Smart Solutions can help

QSS offers regulatory services from registering your cosmetic products to reviewing your cosmetic labels. Our experts are here to help and offer any cosmetic-related regulatory advice!

30 Minutes Free Consultation