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

by | Apr 10, 2020 | COVID-19

Are you a manufacturer and want to help with the COVID-19 Pandemic? Check out our webinar to learn more about FDA’s temporary policies for regulating Personal Protective Equipment (PPE), Reprocessing, Ventilators and Hand Sanitizer manufacturing, and what you need to do to get your product on the market.

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Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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FDA’s Refusal to Accept Process

FDA’s Refusal to Accept Process

Before the submission of a 510(k) premarket notification, the purpose of which is to notify the FDA of the manufacturer’s intent to market a medical device,[i] there is a provision for acceptance review. This review serves as a method to assess whether a submission is administratively complete and includes all necessary information for FDA to determine substantial equivalence under section 513(i) of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 United States Code (U.S.C.) § 360c(i)). To establish substantial equivalence under this provision, FDA must find the same intended use as the predicate device and either have the same technological characteristics as the predicate device or appropriate clinical and scientific data necessary to establish that the device is safe and effective as the predicate device. If the Authority is unable to determine substantial equivalence due to insufficient information, it may request for additional information to make that determination. Therefore, as a part of the acceptance review, the FDA staff follows the acceptance checklist[ii] to ensure that the application is administratively complete. These administrative elements are identified as RTA items and are required to be presented. The purpose of conducting the acceptance review is for the Lead Reviewer to determine whether the 510(k) submission meets the minimum threshold of acceptability and should be accepted for substantive review.[iii]
Empowering Your Workforce through Kaizen

Empowering Your Workforce through Kaizen

Last week, I touched on the idea of involving and empowering all employees in the workplace through the corrective and preventive actions process by fostering taking initiative and a problem-solving (refer to blogpost ‘The Art of Addressing Non-Conformances in Operations’). To expand on this concept a bit further, we’re going to be looking at Kaizen–a continuous improvement strategy in which employees at all levels are also empowered to solve problems towards big gains.
FDA’s draft guidelines on Remote Regulatory Assessments (RRAs)

FDA’s draft guidelines on Remote Regulatory Assessments (RRAs)

The pandemic has been a challenging time for all industries including the Food and Drug Administration (FDA). The FDA had to alter the manner in which it conducted its operations. One set of tools adopted by the FDA in response to COVID-19 was the remote regulatory assessment (RRAs).

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