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News and Info

07 May

FDA Update – Discontinued Medical Devices During the COVID-19 Public Health Emergency

The U.S. Food and Drug Administration has updated their discontinued medical devices list during the COVID-19 Public Health Emergency. The recently added items include gastroenterostomy tubes, gastrointestinal tubes, and accessories. Specific items recently added to the discontinuance list are manufactured by Bard Access Systems: 20F PULL Ponsky 20F PUSH Ponsky Bolus Feeding Tube Button Gastrostomy

27 Apr

Startups: Here’s How You Handle FDA Regulation and Reimbursement

The two “Rs” — regulatory and reimbursement — are critical elements of the environment in which a medical device product is developed. The design of innovative products in the highly regulated medical environment actually influence all stages of medical device development from the earliest stages of the development effort to its conclusion. Let’s first consider

29 Mar

FDA update: Leveraging Real World Evidence in Regulatory Submissions of Medical Devices

By: Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH) and Daniel Caños, Ph.D., M.P.H., Director, Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality, CDRH Among the many ways that the U.S. Food and Drug Administration protects and promotes the public health is by ensuring the safety and

10 Mar

NIOSH Requirements for N95 masks

Industry UPDATE: NIOSH Requirements for N95 masks In response to the nation’s effort to control the spread of COVID-19, the NIOSH Respirator Approval Program is accepting and prioritizing applications received for new approvals and extension of approvals submitted by existing approval holders (both domestic and non-domestic manufacturers) and new domestic respirator manufacturers/applicants. NIOSH considers domestic

25 Feb

FDA Update-FDA Issues Policies to Guide COVID-19 Treatment Development

FDA Issues Policies to Guide COVID-19 Treatment Development On February 22, 2021 the FDA released two guidances regarding the development of COVID-19 drugs. The first guidance specifically deals with the development of monoclonal antibody products, while the second guidance is focused on drugs that treat or prevent COVID-19. These guidances contain non-binding recommendations for sponsors

25 Jan

FDA Update: New devices added to the device discontinuance list.

New devices added to the device discontinuance list. The FDA is constantly reviewing their emergency use list. As we have been writing and warning that as the amount of needed products come to market via the EUA and 510(k) the FDA will discontinue the items. Companies should be away that they will need to have

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