Month: April 2022

News

EUA FDA Transition Plan for Medical Devices in 2022

Post author By Femi Morakinyo
Post date April 29, 2022
No Comments on 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 Therefore, FDA has developed and issued new draft guidance detailing phased transition plans for devices granted EUA designations as well as devices that fall within the enforcement policies issued during COVID-19.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.

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

Tags Eau, Fda, medical devices

Blog

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

Contact Quality Smart Solutions today! We can help.

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

DIN Infographic

OTC Drugs Infographic

References

https://www.canada.ca/en/health-canada/services/self-care-regulation-non-prescription-drugs.html

Tags Drug Products, Drug Regulations, OTC Drugs

Blog

Learn how to differentiate Dietary Supplement vs NHP Labeling

Post author By Quality Smart Solutions
Post date April 18, 2022
No Comments on 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?

The experts at Quality Smart Solutions can help with both!

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.

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!

References

https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/prodnatur/legislation/docs/label-list-etiquet-eng.pdf

https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide-chapter-i-general-dietary-supplement-labeling

Tags Dietary Supplements, Natural Health Products

Blog

4 Tips on How to Complete Your Cosmetic Notification Form

Post author By Andrew Lau
Post date April 11, 2022
No Comments on 4 Tips on How to Complete Your Cosmetic Notification Form

Are you a cosmetics manufacturer or distributor looking to navigate the complex world of regulatory compliance? Look no further than cosmetic notification forms—your roadmap to observation and success. In the ever-evolving cosmetics industry, staying on top of regulations and ensuring product safety is crucial. Understanding and adequately completing cosmetics notification forms allows you to meet legal requirements and build trust with your customers and stakeholders. This comprehensive guide will take you through everything you need to know about cosmetic notification forms, from what they are and why they are essential to how to fill them out correctly. Whether you are a seasoned player in the cosmetics industry or just starting, this guide will equip you with the knowledge and tools to stay compliant, drive growth, and set yourself apart from the competition. Don’t let regulatory hurdles hinder your success; let cosmetics notification forms be your guide to compliance and prosperity.

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.

What are cosmetic notification forms?

Cosmetics notification forms are vital to the regulatory landscape for cosmetics manufacturers and distributors. These forms serve as a means of communication between the industry and regulatory authorities, allowing for the monitoring and regulating of cosmetic products. Cosmetics notification forms provide essential information about the products being placed on the market, including the ingredients used, manufacturing processes, and labeling. By submitting these forms, manufacturers and distributors demonstrate their commitment to transparency and compliance with regulations.

Why are cosmetic notification forms vital for compliance in the cosmetics industry?

Compliance with regulatory requirements is not just a legal obligation; it is also crucial for the success and reputation of cosmetics businesses. Non-compliance can result in fines, product recalls, and damage to brand reputation.

In an industry where consumer trust is paramount, demonstrating compliance through properly completing cosmetics notification forms is a powerful way to build credibility. By proactively meeting regulatory requirements, cosmetics businesses can assure customers that their products are safe, reliable, and in line with industry standards.

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.

How do I complete a cosmetic notification form?

Completing cosmetic notification forms may seem daunting, but it can be straightforward with the right approach. Here’s a step-by-step guide to help you navigate the requirements and ensure accurate and timely submissions:

1. Familiarize yourself with the regulations: Start by understanding the specific rules for your cosmetic products. This will help you identify the relevant forms and the information you need to provide.
2. Gather the necessary information: Collect all the information needed for each form, including product composition, manufacturing processes, and safety data. This may involve liaising with suppliers, conducting lab tests, and reviewing existing documentation.
3. Fill out the forms accurately: Take your time to complete the forms accurately, ensuring that all information is correct and up to date. Pay close attention to details such as ingredient names, concentrations, and units of measurement.
4. Include supporting documentation: Attach any required supporting documents, such as safety assessment reports, test results, or compliance certificates. These documents will strengthen your submission and provide additional evidence of compliance.
5. Review and double-check: Before submitting the forms, thoroughly review them to ensure accuracy and completeness. Check for any errors, missing information, or inconsistencies. It may also be helpful to have a colleague or compliance expert review the forms.
6. Submit the forms as required: Follow the submission process outlined by the regulatory authorities. This may involve electronic submissions, physical copies, or online portals. Be aware of any deadlines or additional requirements for compliance.

By following these steps, you can streamline the process of completing cosmetics notification forms and ensure compliance with regulatory requirements.

What are the common mistakes to avoid when filling out cosmetic notification forms?

While completing cosmetics notification forms, one must be aware of common mistakes that can lead to delays, rejections, or non-compliance. Avoid these pitfalls by keeping the following in mind:
1. Inaccurate or incomplete information: Ensure that all information provided is accurate, complete, and current. Double-check ingredient names, concentrations, and any other relevant details.
2. Missing or incorrect supporting documentation: Include all required supporting documents, such as safety assessments, test reports, or certificates. Make sure these documents are valid, properly labeled, and relevant to the product being notified.
3. Failure to meet labeling requirements: Pay close attention to labeling requirements and ensure all mandatory information is included in the product packaging. This includes ingredient lists, warnings, claims, and proper language translations where applicable.
4. Not keeping up with regulatory changes: Stay informed about any changes or updates to cosmetic regulations that may affect your notification forms. Regularly check for updates from regulatory authorities and adjust your processes accordingly.
By avoiding these common mistakes, you can save time, reduce non-compliance risk, and ensure a smooth notification process.

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?

Contact Quality Smart Solutions today! We can help.

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 the sale

CNF Infographic

What is the role of cosmetic notification forms in ensuring product safety?

Cosmetic notification forms play a crucial role in ensuring the safety of cosmetic products. By providing detailed information on product composition, manufacturing processes, and safety assessments, these forms enable regulatory authorities to assess the potential risks associated with cosmetic products.

By submitting cosmetic notification forms, manufacturers and distributors demonstrate their commitment to product safety and compliance. This helps protect consumers from potential harm and ensures that cosmetic products meet the necessary safety standards.

How do cosmetic notification forms contribute to business success?

Compliance with cosmetics notification forms is not just a regulatory obligation; it can also contribute to the overall success of cosmetics businesses. Here’s how:

1. Building trust and credibility: By demonstrating compliance with regulatory requirements by properly completing notification forms, cosmetics businesses can build trust and credibility with customers, stakeholders, and regulatory authorities. This can increase customer loyalty, positive brand reputation, and better relationships with regulatory bodies.
2. Market access and expansion: Many countries and regions require cosmetics products to be notified before they can be placed on the market. By completing notification forms, businesses gain access to new markets. They can expand their reach, driving growth and increasing sales opportunities.
3. Risk mitigation: Compliance with cosmetics notification forms helps businesses mitigate the risk of non-compliance penalties, product recalls, and damage to brand reputation. By proactively meeting regulatory requirements, companies can avoid costly legal issues and maintain a positive image in the market.
4. Competitive advantage: Compliance with regulatory requirements sets businesses apart. By demonstrating a commitment to product safety and compliance, cosmetics businesses can differentiate themselves in the market and attract customers who prioritize safety and quality.

Resources and tools to help with cosmetics notification form compliance

Navigating the world of cosmetic notification forms can be complex. Still, there are resources and tools available to help businesses stay compliant. Here are some useful resources:

1. Regulatory authorities: Consult the websites and guidelines provided by regulatory authorities in your country or region. They often provide detailed information on the requirements for cosmetic notification forms and offer guidance on accurately completing them.
2. Industry associations: Join associations or organizations dedicated to cosmetics and personal care products. These associations often provide resources, training, and networking opportunities that can help businesses navigate the regulatory landscape.
3. Compliance consultants: Consider working with compliance consultants specializing in cosmetics regulations. These experts can provide valuable insights, guidance, and support throughout the notification process.
4. Technology tools: Explore software solutions to streamline the cosmetics notification process. These tools can automate data management, document generation, and submission tracking, saving time and reducing the risk of errors.

By leveraging these resources and tools, businesses can stay informed, navigate the compliance landscape, and ensure accurate and timely completion of cosmetics notification forms.

Conclusion: The key to compliance and success in the cosmetics industry

Cosmetics notification forms are more than just paperwork – they are a roadmap to compliance and success in the cosmetics industry. By understanding the importance of obedience, familiarizing yourself with the different types of notification forms, and following a step-by-step guide, you can confidently navigate the regulatory landscape.
Businesses can build trust with customers, stakeholders, and regulatory authorities by properly completing cosmetics notification forms.

Compliance ensures the safety and reliability of cosmetic products. It contributes to business success by opening new markets, mitigating risks, and differentiating from competitors.

Utilizing Consultants to Ensure You Fully Comply with Regulations:

It’s always important to seek out professional advice when completing any complex regulatory process, and this includes the completion of cosmetic notification forms. Consulting with an expert in the cosmetics field can help ensure the process runs as smoothly as possible by avoiding any incorrect information or compliance mistakes that could lead to sanctions or fines for your business. Utilizing their expertise will give you complete peace of mind that all aspects are being taken care of correctly and legally, helping you to avoid any unwanted regulation-related problems.

References

https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/regulatory-information.html

https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics/guidance-document-complete-cosmetic-notification-form.html

Tags Cosmetic, Cosmetic Notification, Cosmetic Regulations

Time-limited EUA

FDA Transition Plans for EUA Devices

FDA Transition Plan for Devices Within Enforcement Policies

Resources:

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

2. What licensing is required for OTC drugs?

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

Contact Quality Smart Solutions today! We can help.

References

Introduction

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

The experts at Quality Smart Solutions can help with both!

Summary

References

What is a Cosmetic?

Why are cosmetic notification forms vital for compliance in the cosmetics industry?

What are the common mistakes to avoid when filling out cosmetic notification forms?

Cosmetic Notification Form

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

Contact Quality Smart Solutions today! We can help.

Tips on How to Complete a Cosmetic Notification Form

Utilizing Consultants to Ensure You Fully Comply with Regulations:

References

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