FDA – Page 2

Artificial Intelligence Medical Devices SaMDOctober 15, 2024

Ex-FDA Reviewer On PCCP Policy: ‘Child of Pre-Cert’ Evolves Into ‘No-Surprise’ Tool for Makers of Changing MedTech

By Shawn M. Schmitt Communications Specialist, Enzyme A former US Food and Drug Administration official who contributed to the FDA’s draft guidance shaping the agency’s thinking on Predetermined Change Control Plans for medical devices is bullish on PCCP’s ability to get updated products to patients faster – and believes it’s a win-win for manufacturers and...

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Medical DevicesSeptember 26, 2024

CDRH’s New Era: 6 Key Takeaways From the Shuren/Tarver Town Hall

By Shawn M. Schmitt Communications Specialist, Enzyme For Jeff Shuren, parting ways with the US Food and Drug Administration is such sweet sorrow. He stepped down as the longtime Director of the FDA’s Center for Devices and Radiological Health this summer, paving the way for Michelle Tarver – CDRH’s Deputy Director for Transformation – to...

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Medical DevicesAugust 28, 2024

FDA Still Silent Regarding New QMSR Inspection Regime

The FDA draft rule for regulation of lab-developed tests (LDTs) is no radical departure from the Agency’s traditional regulatory scheme, but it would force clinical labs to conduct a major overhaul of their regulatory operations. There is still a debate as to whether the Agency is fully legally authorized to regulate LDTs, but there are other considerations which suggest the FDA’s timeline for this draft rule is highly ambitious.

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Laboratory-Developed TestsJune 30, 2024

Regulatory Hazards Abound in FDA Final Rule for LDTs

The FDA’s final rule for regulation of lab-developed tests (LDTs) is likely to remain controversial for the foreseeable future, although Congress can still put those controversies to rest. In the absence of legislation, however, clinical labs will soon be subject to an entirely new set of regulatory requirements, drastically elevating the compliance risks for the...

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Laboratory-Developed TestsNovember 20, 2023

The Implications and Timing of the FDA Draft Rule for LDT Regulation

The FDA draft rule for regulation of lab-developed tests (LDTs) is no radical departure from the Agency’s traditional regulatory scheme, but it would force clinical labs to conduct a major overhaul of their regulatory operations. There is still a debate as to whether the Agency is fully legally authorized to regulate LDTs, but there are other considerations which suggest the FDA’s timeline for this draft rule is highly ambitious.

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Medical Devices SaMDOctober 30, 2023

Hazards of Indication for Use Highlighted in FDA Draft Guidance

The FDA’s three September draft guidances for the 510(k) program provide much-needed clarity regarding premarket notifications under the 510(k) program and are part of a set of reforms the Agency proposed in 2018. One of these—the draft guidance for 510(k) clinical data—brings several critical questions into focus, such as the circumstances in which a change in the indication for use may require clinical testing.

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Medical Devices SaMDOctober 24, 2023

New FDA Draft Guidance Provides More Clarity Regarding Predicate Devices

A new draft guidance from the FDA offers insight into the process by which a manufacturer might select a predicate device for a new class II product under the 510(k) program. While this document does not necessarily constitute a new approach to the selection of a predicate device, it does make clear that the FDA strongly prefers that a predicate have a clean record for adverse events (AEs) and device malfunctions.

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PharmaOctober 12, 2023

FDA Guidance Provides Road Map for Use of Real-World Data and Evidence

The new FDA guidance on the use of real-world data (RWD) and real-world evidence (RWE) is a long-anticipated playbook for how a drug manufacturer can employ a non-interventional study for regulatory decision-making. The process is not as simple as extracting observational data from a registry, although the benefits are potentially immense given that the sponsor can avoid the need for an expensive and cumbersome randomized controlled clinical trial (RCT).

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Medical DevicesSeptember 25, 2023

How to Navigate the End of FDA’s Enforcement Discretion Policies

During the COVID-19 public health emergency (PHE), FDA's enforcement discretion policies allowed Americans to have access to numerous medical devices that would traditionally undergo FDA review and clearance/approval without this review. Although this was good for the American public, there was always an outstanding question of what would happen once the PHE ended: How would FDA approach these medical devices and regulate them again? Here's the details of the FDA's transition plan for medical devices as these enforced discretion policies come to an end.

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Medical DevicesSeptember 12, 2023

Key Takeaways from New FDA Guidance on Off-the-Shelf Software

As the number of medical devices that include software continues to grow, so too does the use of off-the-shelf (OTS) software in regulated medical devices. Defined as “a generally available software component used by a device manufacturer for which the manufacturer cannot claim complete software life cycle control (e.g., operating system, printer/display libraries),” OTS software has its own regulatory/quality considerations and deliverables when incorporated into a medical device.

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ENZYME BLOGAnalyzing the latest developments in regulatory, compliance, and quality

Ex-FDA Reviewer On PCCP Policy: ‘Child of Pre-Cert’ Evolves Into ‘No-Surprise’ Tool for Makers of Changing MedTech

CDRH’s New Era: 6 Key Takeaways From the Shuren/Tarver Town Hall

FDA Still Silent Regarding New QMSR Inspection Regime

Regulatory Hazards Abound in FDA Final Rule for LDTs

The Implications and Timing of the FDA Draft Rule for LDT Regulation

Hazards of Indication for Use Highlighted in FDA Draft Guidance

New FDA Draft Guidance Provides More Clarity Regarding Predicate Devices

FDA Guidance Provides Road Map for Use of Real-World Data and Evidence

How to Navigate the End of FDA’s Enforcement Discretion Policies

Key Takeaways from New FDA Guidance on Off-the-Shelf Software

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