Enzyme Blog: Medical Device, Pharma, Biotech, SaMD, & More

Artificial Intelligence Digital Health Medical Devices RegulationOctober 31, 2024

FDA Drives ‘Stake In Ground’ With Glossary For AI, Digital Health Terms

By Shawn M. Schmitt Communications Specialist, Enzyme The US Food and Drug Administration (FDA) has taken a critical step toward ensuring that makers of medical devices are all on the same page when it comes to defining terms related to artificial intelligence (AI) and digital health, says an ex-agency official. Posted online in late September,...

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Artificial Intelligence Medical Devices RegulationOctober 17, 2024

MedTech Makers Can Get Devices to US Market Faster, Hasten Innovation By Drafting PCCP Change Plans, Industry Experts Say

By Shawn M. Schmitt Communications Specialist, Enzyme A Predetermined Change Control Plan (PCCP) submitted to and approved by the US Food and Drug Administration (FDA) as part of the medical device review process can give some manufacturers a leg up by shaving months off of the time it can take for a product to come...

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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Communications Specialist, Enzyme A former US Food and Drug Administration official who contributed to the FDA’s draft guidance shaping the agency’s thinking on Predetermined Change Control Plans for medical devices is bullish on PCCP’s ability to get updated products to patients faster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 DevicesOctober 1, 2024

The Cost of Poor Regulatory: MedTech’s Elephant in the Room?

By Shawn M. Schmitt Communications Specialist, Enzyme When longtime MedTech industry expert Elisabeth George learned in recent years that a medical device manufacturer was using DEHP in products bound for the US market, she immediately knew that someone dropped the proverbial regulatory ball. DEHP – di-(2-ethylhexyl) phthalate – is a potentially cancer-causing chemical, the use...

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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 DevicesSeptember 24, 2024

The Cost of Poor Regulatory: An ‘Invisible Expense’ for MedTech?

By Shawn M. Schmitt Communications Specialist, Enzyme Those who play in the MedTech industry have undoubtedly heard the term Cost of Poor Quality, which, in the simplest of explanations, affixes a price for when a manufacturer makes subpar products and/or operates a problematic quality system. A quick Google search for “Cost of Poor Quality” returns...

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

FDA Drives ‘Stake In Ground’ With Glossary For AI, Digital Health Terms

MedTech Makers Can Get Devices to US Market Faster, Hasten Innovation By Drafting PCCP Change Plans, Industry Experts Say

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

The Cost of Poor Regulatory: MedTech’s Elephant in the Room?

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

The Cost of Poor Regulatory: An ‘Invisible Expense’ for MedTech?

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

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