COVID-19 Resources

The COVID-19 pandemic has introduced unprecedented challenges to the medical device and life-sciences industry. From PPE shortages, remote audits, delays in regulatory processes, and much more. EMMA International has stayed on top of the ever changing quality and regulatory landscape amidst the global public health emergency and has compiled the following resources to keep the life-science industry informed, to ensure life-saving products get to market, and stay on the market.

If you need help navigating through COVID-19 for your medical product, EMMA International is ready to help 24/7. Contact us at 248-987-4497 or email info@emmainternational.com to get connected with our team of experts today!

COVID-19 Whitepapers

The FDA’s Response to COVID-19

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COVID-19 Articles and Webinars

FDA’s Pandemic Recovery and Preparedness Plan

On April 2nd, 2021, the FDA provided an update on its Pandemic Preparedness and Recovery Plan (PREPP) Initiative. The initiative evaluated F...

Understanding the J&J Vaccine Pause

Breaking news hit early this week regarding potential problems with Johnson & Johnson’s one-shot COVID vaccine, causing the FDA and th...

Protecting Public Health During COVID-19

As we face the most challenging public health crises of our lifetimes, celebrating and thanking all those who serve public health each day i...

The COVID-19 Adverse Event Dashboard

The FDA’s adverse event reporting system (FAERS) is a web-based tool that allows users to interactively search and query adverse event dat...

Researchers Develop the New ML Tool for Predicting Progress in COVID-19 Patients

In the current Digital Age, we hear the term Machine Learning (ML) in almost every domain. But what exactly is ML? Simply, ML is a way of pr...

FDA Clarifies The Types Of MDSAP Audits To Be Conducted In The Pandemic

The FDA released an information transmittal to the MDSAP Auditing Organizations on December 31st, 2020 providing further guidance on the exp...

FDA Extends the Timeline to Respond to Additional Information Requests

The FDA revised its guidance document ‘Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Me...

Vaccines with Multiple Doses

COVID-19 vaccines have now been approved for a few weeks, and nearly 2 million people in the United States have received their first dose of...

FDA Authorizes Pfizer-BioNTech’s COVID-19 Vaccine for Emergency Use

In a historic move on Friday afternoon, the FDA granted the first Emergency Use Authorization (EUA) to Pfizer and BioNTech’s COVID-19 vacc...

Health Canada Interim Orders

Health Canada released a notice for the stakeholders of the medical device and drug industry to help them understand the tenure of the inter...

Medical Device EUA Transition Plan

Now more than ever, the Emergency Use Authorization (EUA) pathway for medical devices has become a popular topic. Due to the COVID-19 pandem...

Health Canada Requirements for Face Shields

Health Canada released a new notification on requirements for companies intending to manufacture face shields during the pandemic. Face shie...

Adverse Event Reports for Devices Under an EUA

Hundreds of medical devices have been placed on the US market under an Emergency Use Authorization (EUA) to aid in the fight against COVID-1...

Drug Facility Pre-Inspections During the Pandemic

Drug facility pre-approval inspections are required to grant a complete response letter from the FDA to get a new drug application approved....

A Survey on Current Applications for Tracking COVID-19

The COVID-19 pandemic is still creating headlines in the health care domain. Around the world, governments, and organizations such as World ...

GMP Inspections by Health Canada

As FDA begins to restart on-site inspections of domestic and foreign sites, Health Canada on the other hand has all of its on-site domestic ...

Effective Internal Audits for Medical Device Firms

Internal audits are a critical activity for every medical device firm. Not only are they mandatory per 21 CFR 820.22 and Clause 8.2.4 of ISO...

Health Canada’s COVID-19 Interim Guidance on Hand Sanitizers

Hand sanitizers in Canada are regulated by the Natural and Non-Prescription Health Products Directorate (NNHPD). When the pandemic was at it...

IFU Checklist for Reusable Medical Devices

The EU Compliance and Enforcement Group (COEN) recently released a new guidance document that provides information to the industry on how to...

Convalescent Plasma as a COVID-19 Treatment

I think I can speak for most people when I say that viable treatments and vaccines are desperately needed at this point to overcome the COVI...

Effect of Covid-19 on FDA Formal Meetings and MDUFA

FDA released a guidance document on Monday in the form of a question and answer format to help the industry understand the implications of t...

Supplemental Submissions for PMAs and HDEs During COVID-19

FDA has already issued temporary policies on how it regulates PPEs and various other covid-19 essential medical supplies during this public ...

EUA Template for At-Home COVID-19 Sample Collection Kits

The FDA has recently released a new emergency use authorization (EUA) template aimed at developers of at-home sample collection kits for COV...

New FDA Compliance Program for Combination Product Inspections

Last week the FDA released a new compliance program for inspections of CDER-led or CDRH-led combination products to streamline the approach ...

EU MDD Designation Renewals for Notified Bodies

In light of the COVID-19 pandemic, the EU commission adopted the Regulation (EU) 2020/561 that deferred the application of the EU Medical De...

Changing PMA or HDE Devices During COVID-19

As medical device firms adjust to the new normal in light of COVID-19 hurdles, the FDA continues to issue guidances and relax regulatory req...

FDA’s Revised Policy for Development of COVID-19 Tests

In an effort to accelerate the production of tests for COVID-19, FDA released a new guidance document that will allow for clinical laborator...

FDA’s Plan to Re-Start Routine Inspections

Back in March amid the beginning of the COVID-19 pandemic, the FDA announced that in addition to postponing all international inspections, i...

Digital Health in the Age of COVID-19

The effects of COVID-19 have been widespread across different parts of the medical device world, but the Digital Health sector has seen the ...

FDA Tightens Requirements for Coronavirus Antibody Tests

Back in Mid-March, when the COVID-19 pandemic was starting to take off in the US, the FDA issued a policy that allowed antibody tests to ent...

Notifying CDRH of Device Shortages

COVID-19 has severely disrupted the medical device supply chain. Device manufacturers are typically not required to report shortages of devi...

Clinical Trials During COVID-19

The COVID-19 pandemic has had a broad and prevalent impact on the FDA and “normal” medical device life as the industry knows it. Everyth...

European Emergency Use Routes for COVID-19

In Europe, medical devices are regulated under the Directive 93/42/EEC—the “Medical Devices Directive” (MDD) which is annulled by the ...

Australia’s Response to COVID-19

Just like every other nation, Australia has also taken several measures to respond to the global pandemic. To help prevent shortages of medi...

Infusion Pump Shortages

The COVID-19 pandemic has caused mass shortages of ventilators and PPE globally, but now healthcare workers are starting to see the effects ...

COVID-19 Impact on EU MDR: UPDATE

In our last blog on COVID-19’s impact on the EU MDR, the commission had not yet laid out any intentions of moving the EU MDR deadline, whi...

Health Canada’s Response to COVID-19

Canada has been facing the same difficulties as many other nations due to the novel coronavirus. In light of the shortage of medical equipme...

COVID-19 and the FDA: What Every Manufacturing Company Needs to Know

Are you a manufacturer and want to help with the COVID-19 Pandemic? We invite you to attend our upcoming webinar to learn more about FDA’s...

Marketing Your Hand Sanitizer During the COVID-19 Pandemic

Health care facilities are facing shortages of medical equipment, drugs, PPEs and essentials such as hand sanitizers. Hand sanitizers were t...

FDA’s Temporary Enforcement Policy for Face Masks

Amid the pandemic situation, and states’ officials struggling to secure Personal Protective Equipment, FDA released a guidance document th...

FDA’s Coronavirus Treatment Acceleration Program

On Tuesday, March 31, 2020, the FDA announced a new program aimed at facilitating research and development of COVID-19 treatments. With over...

FDA’s Enforcement Policy for Ventilators During the COVID-19 Pandemic

As COVID-19 cases surge across the country, the health care industry is preparing itself to face ventilator shortages. There are fewer than ...

Working Remotely Through COVID-19

With the number of confirmed COVID-19 cases now exceeding 200,000 globally, the WHO and many other international government agencies are eit...

COVID-19 Impact on the EU MDR

With the COVID-19 pandemic halting life as many know it globally, the May 26th EU MDR deadline still looms over the medical device industry....

FDA & the Coronavirus (COVID-19) Pandemic

Amid the COVID 19 pandemic, with 10 states in the US declaring a ‘state of emergency’, foreign and international travel restrictions, FD...

COVID-19 Medical Supplies Shortage

As the spread of the 2019 Coronavirus Disease (COVID-19) continues to grow globally, the FDA and other global health organizations have had ...

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