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EUA FDA Transition Plan for Medical Devices in 2022

Post author By Femi Morakinyo
Post date April 29, 2022
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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 Therefore, FDA has developed and issued new draft guidance detailing phased transition plans for devices granted EUA designations as well as devices that fall within the enforcement policies issued during COVID-19.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

News

Your Health Canada eMCE Update For 2022

Post author By Femi Morakinyo
Post date February 5, 2022
No Comments on Your Health Canada eMCE Update For 2022

Manufacturers and companies exporting medical devices from Canada may be asked by foreign customers or foreign governments to supply certification that their medical devices can be marketed in Canada and meet Canadian regulations. As a service to the Canadian medical industry, Health Canada through the Regulatory Operations and Enforcement Branch (ROEB) issues these certificates to facilitate the export process. The Manufacturer’s Certificate to Export licensed medical devices from Canada (MCE) includes an attestation by both the manufacturer and by Health Canada. To obtain an MCE, the following requirements must be met:

the medical device is manufactured in Canada
the medical device has an active Canadian device license for Class II, III, and IV devices, or
the manufacturer of a Class I device has an active MDEL

Previously, the application process for MCE has been manual / paper-based with the applicant sending a completed and notarized application form as well as supporting documentation submitted to the Medical Devices Compliance and Licensing Unit of the Regulatory Operations and Enforcement Branch of Health by regular mail. Unfortunately, due to the impact of Covid-19 pandemic, Health Canada stopped processing requests for paper-based MCE.

Here comes the good news, Health Canada on January 5, 2022, announced the launch of the pilot program for electronic MCE (eMCE). This process will replace the suspended paper-based process that requires wet-ink signature from the company official. The new eMCE with e-signature is a more efficient process that offers a more environmentally friendly way of doing business. Aside from this benefit, eMCE will no longer require additional documentation, such as a cover letter, notarized form, and a copy of all listed licences. In addition, the new eMCE application form will produce a certificate entitled “MCE/Certificate of Free Sale”

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Steps to completing the new eMCE application form

For each licensed or authorized medical device that you intend to export, complete the licensing or authorization information for each medical device.
For medical device(s) with a medical device establishment licence (Class I), provide the licence number, company ID and device name.
For medical device(s) with a medical device licence (Class II-IV), provide the licence, device ID, Class of the device and the device name.
For medical device(s) with an interim order authorization, provide the authorization ID, authorization date, device name, device ID and the manufacturer’s name.
Provide the name and address for the manufacturer of the device(s). This should be the name of the MDEL, MDL or IO authorization holder.
Submit a completed and electronically signed eMCE application with supporting documentation* to the Medical Devices Compliance and Licensing Unit of the Regulatory Operations and Enforcement Branch of Health Canada.

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*Supporting Documentation

Class II, III or IV devices — a copy of the Medical Device Licence (MDL) for each device.
Class I devices — a copy of the Medical Device Establishment Licence (MDEL).
Class I, II, III or IV devices authorized under the IO — a copy of the IO authorization for each device as applicable.

Features of the eMCE

The eMCE will be digitally signed with an electronic signature that authenticates the signer’s identity and demonstrates proof of signing. The certificate will also be locked to protect the integrity of the certificate and prevent any modifications to the document from being made after it is signed and prevent the content in the certificate from being copied. The electronically signed certificates will be sent by email only to the applicant’s email address, which was used to submit the application.

The eMCE pilot project will last for 6 months from January 5, 2022.

Resources:

Health Canada Launches Electronic Manufacturer’s Certificate to Export.

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/electronic-manufacturer-certificate-export-medical-devices.html

Guidance to apply for a Manufacturer’s Certificate to Export licenced medical devices from Canada (GUI-0097)

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/application-manufacturer-certificate-cover-export-medical-devices-0097/document.html#a4

Tags Health Canada, Manufacturer’s Certificate to Export, Mdel, Medical Device Licence

Blog

How Your NHP & Drug Products are Reviewed in Canada CTA v.s NDS

Post author By Femi Morakinyo
Post date January 19, 2022
No Comments on How Your NHP & Drug Products are Reviewed in Canada CTA v.s NDS

In general, all drug products (including over-the-counters and biologics) must be authorized for sale by Health Canada, before they can be distributed in the Canadian market. Drugs include both prescription and non-prescription pharmaceuticals; biologically derived products such as vaccines, blood derived products, and products produced through biotechnology; tissues and organs; disinfectants; and radiopharmaceuticals.

Natural health products, such as vitamin and mineral supplements and herbal products for which therapeutic claims are made are also considered drugs at the level of the Food and Drugs Act; however, these products are regulated as natural health products under the Natural Health Products Regulations and not as drugs under the Food and Drug Regulations.

Health Canada will generally authorize a drug product after a drug review process to assess the safety, efficacy, and quality of a drug and if it is satisfied that:

the overall intended benefits to a user of the therapeutic product outweigh the overall risks associated with the use of the therapeutic product; and
the therapeutic product is suitable for its intended purpose and that any risk associated with its use is minimised, based on its formulation, manufacturing process controls, specifications, and shelf life, as well as its stability under the recommended storage conditions.

Steps to obtain authorization to develop, test, and/or market a drug product

It is important to quickly mention that “drug development” as a process of bringing a new drug molecule into clinical practice in its broadest definition encompasses all steps from the basic research process of finding a suitable molecular target to supporting the commercial launch of the drug. However, before testing a drug in humans, scientists must test whether it has the potential to cause serious harm, also called toxicity via in vivo experiments, in vitro experiments, or both. If the results are promising – demonstrate acceptable safety levels and clear or potential efficacy, the team will proceed to the next step of development. This step requires an application to Health Products and Food Branch of Health Canada for authorization to conduct a clinical trial in Canada.

1. Clinical Trial Application (CTA): If the preclinical research indicates that a substance produces the desired result and is not toxic, the sponsor applies to Health Products and Food Branch (HPFB) of Health Canada to conduct a clinical trial in Canada. According to NIH, “clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment”.

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The Health Canada review team has 30 days to review a CTA from the date of receipt of a complete application in Health Canada. The application first undergoes a screening phase to ensure that all submission components have been provided. Once screened for acceptability, the application is processed for review and an acknowledgement letter is issued to the sponsor to indicate the start of the review period. Once review is completed, the application is either authorized (a No Objection Letter is issued) or rejected (a Not Satisfactory Notice is issued). It is worth noting that CTAs are required for only phases I to III clinical trials. Clinical trials involving marketed drugs where the investigation is to be conducted within the parameters of the authorized NOC or DIN application (Phase IV clinical trials) do not require a CTA.

2. New Drug Submission (NDS): If clinical trial studies prove that the drug has potential therapeutic value that outweighs the risks associated with its use (e.g. adverse effects, toxicity), the sponsor may choose to file a NDS with HPFB. The NDS must provide information and data about the drug’s safety, effectiveness and quality. And this includes the results of the preclinical and clinical studies, whether done in Canada or elsewhere, details regarding the production of the drug, packaging and labelling details, and information regarding therapeutic claims and side effects.

Within the first 10 day after receiving the application, Health Canada will assign a control number to the submission and subject the application to a thorough screening to ensure that the correct application type has been selected, that the format, structure and attributes of electronic data submitted comply with the CTD format and specifications, and that the submitted dossier is complete. Where the HPFB identifies deficiencies in the dossier, it will send a query stating the same to the applicant and put in place a stop-clock, which ends when the HPFB receives a complete and satisfactory response.
Upon acceptance of the application, the HPFB will begin its evaluation. Similarly, a stop-clock starts when the HPFB issues a query to the applicant and ends when a complete and satisfactory response is received. Where necessary, the HPFB may involve external evaluators (whose identities will be kept confidential), experts and advisory committees. The external evaluators and experts are contractually bound to protect information provided to them. In addition to evaluating the safety, efficacy and quality data to assess the potential benefits and risks of the drug, the review team evaluates the information that the sponsor proposes to provide to health care practitioners and consumers about the drug such as the label, product brochure and information sheets.
Following the completion of the review, if the conclusion is that the benefits outweigh the risks and that the risks can be mitigated, the drug is issued a Notice of Compliance (NOC), as well as a Drug Identification Number (DIN) which permits the sponsor to market the drug in Canada. Suffice to mention that following product registration, product registrants are responsible for ensuring the product’s quality, efficacy, and safety throughout its life cycle, and must notify Health Canada of any changes to the same.
In instances where there is insufficient evidence to support the safety, efficacy or quality claims, HPFB will not grant a marketing authorization for the drug and a Notice of Non-Compliance (NON) will be issued to the sponsor. Meanwhile, the sponsor has the opportunity to supply additional information, to re-submit its submission at a later date with additional supporting data, or to ask that HPFB reconsider its decision.
There are also instances when the application can be approved subject to adequate response to minor deficiencies. The HPFB will inform the applicant of the approval conditions (Notice of Compliance with Conditions Qualifying Notice (NOC/c-QN), and the applicant will need to satisfy these conditions within a specified time period.
Although HPFB has set internationally competitive performance targets for its conduct of reviews, the review time depends on the product being submitted and the size and quality of the submission, as well as HPFB’s workload and human resources. Other factors include the number of questions that Health Canada raises during the review process, the answers provided by the sponsor and the clock-pauses. Nevertheless, the target review timeline ranges between 7 months (accelerated review and ANDS) to 1 year (standard NDS).

References:

What Are Clinical Trials and Studies? https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies

How Drugs are Reviewed in Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/drugs-reviewed-canada.html

Clinical Trial Applications (CTAs) https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/applications.html

Guidance Document: The Management of Drug Submissions and Applications. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions/industry/document.html#a90

Tags Clinical Trial, DPD, Drugs, HPFB

News

End of DEL transition period for Hand Sanitizers

Post author By Femi Morakinyo
Post date December 1, 2021
No Comments on End of DEL transition period for Hand Sanitizers

In the wake of the COVID-19 pandemic, preventive measures and a healthy lifestyle with an efficient immune system were suggested by the World Health Organization (WHO) to fight and stay safe from COVID-19. Adaptation of effective hand hygiene is vital, as advised by WHO to wash or sanitize your hands frequently with soap or >60% alcoholic hand sanitiser, respectively. The recommendation is based on fast, effective, and broad-spectrum antimicrobial activity combined with easy availability and considered safe. It is therefore not surprising to see the demand for hand sanitiser go threw the roof immediately after the preventive declaration was made.

In Canada, Health Canada responded with an interim and expedited licencing approach for the production of and distribution of alcohol-based hand sanitisers to facilitate increased access to safe and effective hand sanitizers. The interim measure simplifies the application process and prioritizes the review process for both site licenses (Drug Establishment Licence, DEL) and product licenses.

Given the interim nature of the DEL issued under this interim measure, certain GMP requirements for natural health products (NHPs) were waived during this period. Specifically, stability testing was not required; a quality assurance report or other forms of evidence required as part of the standard process was not required; and for products containing more than 50% alcohol, finished product testing for microbiological contaminants was not required. Many other stringent GMP requirements for safety and efficacy were however retained to ensure the production of safe and effective hand sanitizers.

Consolidating on the interim order and as the demand for alcohol-based hand sanitizers stabilized, Health Canada through the Natural and Non-Prescription Health Products Directorate (NNHPD) announced in March 2021 the intention to bring an end to the Covid-19 interim order. Specifically, Health Canada set forth to end the temporary COVID-19 site licences (COVID-19 SL) for manufacturing, packaging, labelling and/or importing alcohol-based hand sanitizers on September 30, 2021. It therefore meant Health Canada was lifting flexibilities for drug establishment licences (DELs) under the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. Furthermore, a DEL will now be required to conduct licensable activities for designated hand sanitizers (fabricate, package/label, test, import, or distribute) and a six-month transition period was provided to allow interim SL holders to apply for a valid DEL to continue producing hand sanitizer. Otherwise, an interim SL holder is required to stop manufacturing, importing, packaging, labelling, or distributing alcohol-based hand sanitizers.

Considering that the Drug Establishment Licence (DEL) transition period for designated hand sanitizers ended on September 1, 2021, companies that failed to apply for a DEL (or to amend a DEL) must cease all licensable activities related to designated hand sanitizers that were authorized under the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. However, if you would like to continue manufacturing, importing, packaging, labelling, or distributing alcohol-based hand sanitizers, you need to apply for a new DEL and wait for approval to conduct these licensable activities. Contact Quality Smart Solutions for assistance!

References

Expedited access to disinfectants, hand sanitizers and personal protective equipment to help limit the spread of COVID-19, as well as swabs for testing https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72623a-eng.php

Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/covid19-interim-order-drugs-medical-devices-special-foods.html

World Health Organization, 2020. WHO guidelines on hand hygiene in health care: first global patient safety challenge clean care is safer care. Geneva: the Organization [cited 2020 Apr 08]

Tags DEL, Drug Establishment Licence, Hand Sanitizer

Blog

Registering Products with the EPA – What You Need to Know

Post author By Femi Morakinyo
Post date November 29, 2021
No Comments on Registering Products with the EPA – What You Need to Know

The US Environmental Protection Agency (EPA) is saddled with the responsibility to register pesticides in the US. This process is a combination of scientific, legal, and administrative procedures through which the EPA examines the ingredients of the pesticide the site or crop where it is to be used the amount, frequency, and timing of its use and storage and disposal practices.

Pesticides products in the US can be categorized into 3 groups – conventional pesticides, antimicrobial pesticides, and biopesticides. The EPA’s conventional pesticides group includes all ingredients other than biological pesticides and antimicrobial pesticides. As for antimicrobial pesticides, they are substances or mixtures of substances used to destroy or suppress the growth of harmful microorganisms whether bacteria, viruses, or fungi on inanimate objects and surfaces. The antimicrobial category is also known as a “disinfectant” in other countries. Meanwhile, biopesticides are pesticides derived from certain natural materials. Irrespective of the type of pesticides, and/or whether they are produced locally or by foreign manufacturers and imported for sale or distribution in the United States, they are required to be registered with EPA for sale in the United States.

Registration for a Pesticide Product

If you would like to obtain a registration for a pesticide (or disinfectant) product, you are required to submit complete information and data to support the registration. The information required includes but is not limited to the following:

Company number – a number assigned by EPA to your company
Establishment number (if applicable) – a unique number assigned to each production facility
Identity of the product – the unique brand name of the product
Draft label – critical information about how to handle and safely use the pesticide product and avoid harm to human health and the environment
Applicable scientific data on product chemistry, residue chemistry, environmental fate, toxicology, wildlife, and aquatic organism among others
Efficacy (Product Performance) data – applicable to control pests of public health importance such as roaches, viruses, pathogenic bacteria, ticks, rats among others
Child-resistant packaging certification
Confidential Statement of Formula
US Agent (only for applicants not residing in the US)

Obtaining a Supplemental Registration to Distribute a Product Registered by Someone Else

An applicant who does not wish to register and produce its unique product (but would rather market a product that is currently registered to another company) may become a supplemental registrant for the company that has already registered the product. This supplemental registration allows the new registrant to market the product under its own company and brand name. To use the supplemental registration process, both parties (the original registrant and the supplemental distributor) must submit a complete application detailing the:

address of the registrant of the basic registered product
basic registered product and the registration number of the federally registered product
name and address of the distributor, the distributor’s company number, and the name of the distributor product

It is instructive to note that supplemental registration is an extension of the basic registration and if the basic registered product is canceled, the supplemental registration is automatically canceled effective on the same date as the basic registered product, and existing stocks must be sold in the same time period.

Screening and Review Timelines

As soon as the application for pesticide/disinfectant registration is submitted to EPA, the Agency will screen the application within 21 days to determine if it contains all required forms, labeling, data format, and documentation of fee payment. Any deficiencies identified during the 21-day Content Screen and uncorrected by the applicant may lead to the Agency’s rejection of the application and retention of 25% of the fee.

Following the 21-day Content Screen, EPA will conduct a Preliminary Technical Screen within 45 days after the start date for pesticide/disinfectant submissions with decision review timeframes ≤6 months, and, within 90 days for pesticides/disinfectant submissions with decision review timeframes > 6 months.

If the application fails the technical screen, and the deficiencies cannot be corrected by the applicant within 10 business days after receipt of EPA’s notification of deficiencies, such application will be rejected and a maximum of 75% fee refund may be provided, if appropriate.

References: Environmental Protection Agency. (n.d.). Pesticide Registration Manual. EPA. Retrieved October 20, 2021, from https://www.epa.gov/pesticide-registration/pesticide-registration-manual

Tags Disinfectant, EPAs, Pesticide