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2020-7-29 · In addition to the "umbrella" EUA for Face Masks, as described in the FDA’s policy on face masks and surgical masks that is in effect during the COVID-19 public health emergency, the FDA does ...

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2020-9-4 · The FDA recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits, may outpace the supply available to …

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Introduction

Search Registration and Listing | FDA

2020-8-17 · USA.gov; Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds. FDA Homepage. Contact Number 1-888-INFO-FDA

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FDA Approval of Color Additives FDA approval is required for color additives used in food, drugs, cosmetics, and some medical devices. Certain high-risk colors also require FDA color batch certification of every individual batch. Color additives may only be used in compliance with their approved uses, specifications, and restrictions.

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FDA says it will allow the distribution and use of surgical masks, which are Class II devices, without 510(k) clearance, given that the masks meet certain standards for fluid resistance and flammability and include accurate labeling.

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FDA Approval of Color Additives FDA approval is required for color additives used in food, drugs, cosmetics, and some medical devices. Certain high-risk colors also require FDA color batch certification of every individual batch. Color additives may only be used in compliance with their approved uses, specifications, and restrictions.

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2018-10-16 · The surgical mask shall not disintegrate, split or tear during intended use. 5.1.2 Design The surgical mask shall have a means by which it can be fitted closely over the nose, mouth and chin of the wearer and which ensures that the mask fits closely at the sides. 5.2 Performance requirements 5.2.1 Bacterial filtration efficiency (BFE)

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2020-9-6 · The surgical mask is a medical device that covers the mouth, nose, and chin, and provides a barrier that limits the passage of an infective agent between hospital staff and the patient. It was originally developed to contain and filter large droplets of microorganisms that are discarded from the mouth and nasopharynx of healthcare professionals ...

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In May 2017, the European Commission put forward a new Medical Device Regulation with reference Regulation (EU) 2017/745 (hereafter: MDR). This new Regulation is set to become fully effective in 2021* and will replace the Medical Device Directive (MDD) 93/42/EEC that currently regulates medical devices.