FDA Authorizes a COVID-19 Diagnostic Test for Asymptomatic Individuals

One of the challenges in controlling the rate of new infections during the COVID-19 pandemic has been the lack of a diagnostic test specifically indicated for asymptomatic patients. According to some estimates, nearly 40% of the new cases of SARS-CoV-2 infections do not have any visible symptoms. As a result, many of those infected are not aware they are carrying the virus and may be inadvertently adding to the rising rates of new infections. A newly authorized diagnostic test for asymptomatic patients could help.

Regulatory News, Industry NewsNaveen AgarwalAugust 3, 2020COVID-19, covid-19, asymptomatic, diagnostic testing, diagnosis, FDA regulation, FDA News, FDA authorization, coronavirus crisis, coronavirus, FDA approves coronavirus tests, FDA approvalComment

FDA Guidance for Face Shields and Respirators During the Covid-19 Pandemic

The medical landscape is constantly changing, particularly during the COVID-19 pandemic. With so much happening, there is a lot of confusion, particularly surrounding shortages of Personal Protective Equipment (PPE) and Face Masks. The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. In this article, we will cover Face Shields and Respirators.

Industry News, Regulatory NewsNaveen AgarwalJuly 10, 2020COVID-19, covid-19, coronavirus criss, coronavirus crisis, coronavirus pandemic, FDA, FDA regulation, FDA authorization, FDA News, respirators, N95 masks, face shields, face masksComment

FDA Guidance for Face Masks During Covid-19 Pandemic

Since the onset of the COVID-19 pandemic, there has been a lot of conversation surrounding the shortages of Personal Protective Equipment (PPE). In particular, we hear a lot about face masks and how they can help prevent the spread of COVID-19. But there is a lot of confusion out there - and many strong opinions - both for and against the use of face masks! In this article, we explain the FDA requirements, and guidance for face masks when they are used for a medical purpose such as diagnosis, or cure, mitigation, treatment of prevention of disease.

Regulatory News, Industry NewsNaveen AgarwalJuly 6, 2020COVID-19, covid-19, sars-cov-2, coronavirus crisis, coronavirus pandemic, ppe, surgical masks, face masks, FDA regulation, FDA authorization, FDA guidanceComment

How MedTech is Rising to Help Combat the Coronavirus Pandemic

Industry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA.

Industry NewsNaveen AgarwalMarch 21, 2020COVID-19, coronavirus, coronavirus criss, medtech, coronavirus pandemic, FDA regulation, FDA authorization, FDA approves coronavirus tests, emergency use authorization, SARS-CoV-19Comment

How FDA is Shaping a Regulatory Policy for Device Cybersecurity

Updated draft guidance provides recommendations for design, labeling, and premarket documentation. Industry response points to a long road ahead before it can be finalized.

Regulatory ComplianceNaveen AgarwalNovember 20, 2019FDA medical devices, FDA guidance, regulatory policy, regulatory news, device cybersecurity, medical device security, medical device cybersecurity, FDA safety, FDA regulation, WannaCry ransomware attack, WannaCry ransomware, URGENT/11, healthcare, cyberthreats in healthcare, healthcare securityComment

A Pathway to Faster FDA Approvals

FDA is expanding the Abbreviated 510(k) Program with a Safety and Performance-based Pathway for certain medical devices.

Regulatory ComplianceNaveen AgarwalOctober 15, 2019FDA, FDA approval, FDA regulation, FDA program, Abbreviated 510(k) Program, medical devices, medical device approvals, FDA medical devices, FDA regulations, medical complianceComment

How to Avoid a Warning Letter from the FDA

A frequent reason for FDA warning letters is an inadequate corrective action plan to form-483 observations. When it is related to risk management, you need to dig deeper.

Regulatory ComplianceNaveen AgarwalOctober 2, 2019FDA warning letter, FDA guidance, FDA regulation, FDA draft guidance, Risk management for medical devices, form-483Comment

A New FDA Guidance Encourages Development of Safer Medical Devices

FDA has issued a draft guidance on the Safer Technologies Program (STeP) for Medical Devices to promote expedited development and regulatory review of safety innovations. This is certainly a STeP in the right direction!

Regulatory ComplianceNaveen AgarwalSeptember 20, 2019FDA, FDA regulation, FDA guidance, Medical device safety, FDA safety, safer technologies program, medical device safety action planComment

FDA Recognizes It's Time for QSR 2.0

FDA first announced its intention to “harmonize and modernize” the Quality System Regulation (QSR) for medical devices in Spring of 2018. The idea is to modernize the regulatory framework and harmonize the requirements with the newly revised ISO 13485:2016, the international standard for medical device quality management systems.

Well, it’s about time!

Regulatory ComplianceNaveen AgarwalJune 20, 2019risk management, FDA regulation, safety, medical safety, patient safety, quality system regulation, qsrComment

Can Your Risk Management Prevent a Recall?

Even if you have not had a recall, or your products are not in the top medical specialties cited in this article, there is a good chance your Quality Management System (QMS) is also vulnerable to deficiencies in these areas.

Risk ManagementNaveen AgarwalJune 12, 2019FDA regulation, safety, medical safety, patient safety, Class I Recall, Medical Device RecallsComment

When a Warning Fails

A warning letter is the agency’s way of giving you a final chance. Behave, or you will face painful enforcement actions such as a recall, seizure, civil money penalties, or worse still, jail time for responsible individuals. It carries a big stick, and predictably, manufacturers have been quite fearful of receiving a warning letter.

Regulatory ComplianceNaveen AgarwalMay 7, 2019risk management, FDA regulation, safety, medical safety, patient safetyComment

Achieving Excellence in Medical Device Benefit-Risk Assessments

Medical devices save lives, but they are not without risk. Whether it is a disposable soft contact lens used on a daily basis, or an intraocular lens surgically implanted to treat cataract, use of medical devices can potentially result in serious injury or even death. There are thousands of medical devices on the market, but there are also reports of millions of injuries and thousands of deaths associated with these devices in the last 10 years.

Risk ManagementNaveen AgarwalApril 22, 2019FDA regulation, safety, medical safety, patient safetyComment

Regulatory Policy in the Age of Artificial Intelligence

Artificial intelligence (AI) based devices are unique in their ability to learn from real-world use and experience, which can translate to rapid improvement in performance and new applications. In a sign of recognition of this capability, the FDA is proposing a new regulatory framework for review and approval of modifications to these devices after they have been cleared or approved.

Regulatory ComplianceNaveen AgarwalApril 9, 2019regulatory compliance, regulatory policy, artificial intelligence, artificial intelligence in healthcare, FDA regulationComment