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Masks and N95 Respirators | FDA

An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. The ‘N95’ designation means that when subjected to careful testing, the respirator blocks at least 95 percent of very small (0.3 micron) test particles.

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510(k) Clearances | FDA

Overview. Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed...

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Pricing and Market Access Outlook ... cases relating to high-cost drug launches and price increases for marketed therapies. In Europe, action has already been taken to restrict the pricing for new drugs and we expect this to continue in the near future. However, in the United States (US),

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