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FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

FDA Law

The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ). By Steven J.

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Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA Law

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ). The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

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CDRH Looks Towards the End of the Public Health Emergency and Transition for EUA and Devices Marketed Under Enforcement Discretion

FDA Law

At a high level, FDA will be allowing manufacturers a period of no less than 180 days to submit a premarket submission for devices marketed under an EUA or an enforcement policy. Manufacturers planning to continue commercial distribution to submit a premarket submission (e.g., Copies of the guidances can be found here and here.

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A Final LDT Rule in April!? Will FDA be prepared?

FDA Law

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

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FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. We find that this information is noteworthy for manufacturers to consider.

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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law

STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs. In response, FDA memorialized its intention to use some of the new tools explored during the pandemic and potentially make them more permanent fixtures of facility inspections (e.g.,

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Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

FDA Law

In contrast, AMP and ACLA both asserted that the rule would harm medical care. That, of course, is not unique to labs with LDTs; kit manufacturers also need to obtain those insights well before they begin studies.) The materials from this webinar are still available on FDAs website ( here ). By Allyson B. Mullen & Jeffrey N.