Kristin Zielinski Duggan

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Articles

Device makers must verify third-party lab data, FDA warns

Feb 26, 2024 | lexology.com | Randy Prebula |Jodi Scott |Kristin Zielinski Duggan

On Tuesday, the U.S. Food and Drug Administration (FDA) issued a letter warning medical device manufacturers and sponsors of device studies to carefully evaluate the third parties that they engage to conduct performance testing, and to independently verify all testing results to the extent possible before submitting data to FDA.
FDA proposal classifying wound dressings/washes with antimicrobials may require PMAs, new 510(k)s | JD Supra

Dec 7, 2023 | jdsupra.com | Sanchita Bose |Michael Druckman |Kristin Zielinski Duggan

The proposed rules, Rule 1 and Rule 2, would implement classification of currently unclassified, pre-amendments wound dressings and liquid wound washes containing antimicrobials and/or other chemicals. Such products are currently regulated through the 510(k) pathway. The proposed classification is informed largely by feedback taken from previous FDA panel meetings held in 2005 and 2016, which we summarized online here.
FDA broadens scope on communication about unapproved uses to HCPs | JD Supra

Oct 26, 2023 | jdsupra.com | Kristin Zielinski Duggan |Heidi Forster Gertner |Sally Gu

Since 2009, FDA has been operationalizing the “scientific exchange” safe harbor by way of 1) its 2014 “Revised Draft Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses-Recommended Practices” often referred to as “Good Reprint Practices,” which permitted companies to disseminate certain publications about unapproved uses, and 2) the 2011 “Draft Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information about Prescription...
FDA broadens scope on communication about unapproved uses to HCPs

Oct 26, 2023 | lexology.com | Sally Gu |Meredith Manning |Heidi Forster Gertner |Kristin Zielinski Duggan

The U.S. Food and Drug Administration (FDA) published new draft guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU Guidance), describing permissible dissemination of scientific information on unapproved uses (SIUU) of approved/cleared medical products by firms to health care providers (HCPs); in other words, certain “off-label” information.
FDA Proposals Clarify Rules For Devices With Predicates

Oct 24, 2023 | law360.com | Lina R. Kontos |Kristin Zielinski Duggan |Kelliann H. Payne

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FDA fills 510(k) guidance gaps with drafts on predicate devices, clinical data, implantables | JD Supra

Sep 13, 2023 | jdsupra.com | Kristin Zielinski Duggan |Lina R. Kontos |Kelliann H. Payne

Since 2009, the average page count of a 510(k) premarket notification submission to the 510(k) Program has more than doubled, to over 1,000 pages, partially as a result of updated FDA policies surrounding premarket submission content requirements, and because medical devices are growing more complex and innovative.
FDA fills 510(k) guidance gaps with drafts on predicate devices, clinical data, implantables

Sep 12, 2023 | lexology.com | Lina R. Kontos |Kristin Zielinski Duggan |Kelliann H. Payne

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has issued three new draft guidances as part of an effort to modernize its 510(k) Program for new products that can be found substantially equivalent to existing, marketed “predicate devices.” The draft guidances address areas where detailed guidance was previously lacking or had not yet evolved to reflect trends identified by FDA through ongoing review of premarket submissions, addressing: (1) best...

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Kristin Zielinski Duggan

Articles

Device makers must verify third-party lab data, FDA warns

FDA proposal classifying wound dressings/washes with antimicrobials may require PMAs, new 510(k)s | JD Supra

FDA broadens scope on communication about unapproved uses to HCPs | JD Supra

FDA broadens scope on communication about unapproved uses to HCPs

FDA Proposals Clarify Rules For Devices With Predicates

FDA fills 510(k) guidance gaps with drafts on predicate devices, clinical data, implantables | JD Supra

FDA fills 510(k) guidance gaps with drafts on predicate devices, clinical data, implantables

Contact details

Emails

Socials & Sites