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The Future Of Vision And Eye Care

The Medical Futurist

Researchers say that the implant cannot provide any highly detailed vision – but it can help patients detect distinct patterns such as door frames and shapes. Their research showed promising results for lab rats, and they plan to carry out the first human trials in the second half of 2017 and gather preliminary results during 2018.

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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting. of ISO 10993-1:2018, but is extremely burdensome and not referenced in the related ISO 10993-18.

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(Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for Compliance

FDA Law Blog

provides an optional alternative streamlined approach for current good manufacturing practices (cGMPs) for manufacturers of drug-device combination products (CPs). FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. 21 C.F.R. § or that FDA proposes can satisfy the requirements in § 4.4

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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. 510(k) Time to MDUFA IV Decision.

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Time for Geriatric Assessments in Cancer Care: William Dale, Mazie Tsang, and John Simmons

GeriPal

William: So ASCO decided to make a high priority this year to redo the guidelines, which were originally released in 2018. So I make the point, they often say, “Oh, you have this special population,” like pediatrics, where it’s 10% or something. Or electronically, to fill out, right? Do you worry about that?

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DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

FDA Law Blog

DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. DEA published the original Special Surveillance in May 1999.

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Jumpstarting Goals of Care Convos: Erin Kross, Bob Lee, and Ruth Engelberg

GeriPal

Summary Transcript Summary Today’s podcast is a follow up to our 2018 podcast with Randy Curtis about the Jumpstart intervention. It’s really special to be here and to be talking about this paper, which was really important to Randy. So what’s changed since 2018 with Jumpstart? Erin: Yeah, I can go first.