Deborah Shuff

Deborah Shuff

Saul Ewing LLP

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Latest Publications


FDA Releases Draft Guidance To Help Determine Substantial Equivalence for a Device that Has Different Technological...

In a new Draft Guidance entitled, Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics, (the “Draft Guidance”) released on...more

8/6/2014 - Draft Guidance FDA Medical Devices Notice Requirements Premarket Approval Applications Risk Assessment Technology

FDA Seeks Comments for Draft Guidance Regarding Expedited Access for Premarket Approval of Medical Devices Intended for Unmet...

The Food and Drug Administration (FDA) released a draft guidance on April 23, 2014 titled Expedited Access for Premarket Approval [of] Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly...more

5/29/2014 - EAP FDA Healthcare Medical Devices

D.C. Circuit Court of Appeals Upholds FDA Oversight of Autologous Stem Cell Therapeutics

A company that developed a stem cell-based therapy for treating diseases and conditions was found to be in violation of the federal Food, Drug, and Cosmetic Act for failing to seek approval for its product. Cellular and...more

2/28/2014 - DNA FDA FDCA Life Sciences Public Health Service Act Stem cells

Cybersecurity Measures to be Included in Premarket Submissions for Medical Devices

The FDA recently issued a Safety Communication on cybersecurity and medical devices and draft guidance recommending that manufacturers specifically address cybersecurity in premarket submissions for medical devices....more

7/4/2013 - Cybersecurity FDA Medical Devices Premarket Approval Applications

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