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

FDA Guidance Provides Relief for MDR Reporting During a Pandemic

Timely MDR reporting is a challenging regulatory requirement for the industry. A new FDA guidance provides much-needed relief during a pandemic.

Regulatory ComplianceNaveen AgarwalMarch 22, 2020FDA guidance, MDR, MDR reporting, pandemic, coronavirus crisus, coronavirus pandemic, adverse event reporting, COVID-19, FDA reporting requirements, MDR reporting update, FDA Medical Device Reporting GuidanceComment

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Updated draft guidance provides recommendations for design, labeling, and premarket documentation.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

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Regulatory ComplianceNaveen AgarwalOctober 2, 2019FDA warning letter, FDA guidance, FDA regulation, FDA draft guidance, Risk management for medical devices, form-483Comment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FDA has issued a draft guidance on the Safer Technologies Program (STeP) for Medical Devices to promote expedited development and regulatory review of safety innovations.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