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Communications Specialist, Enzyme A former US Food and Drug Administration official who contributed to the FDA’s draft guidance shaping the agency’s thinking on Predetermined Change Control Plans for medical devices is bullish on PCCP’s ability to get updated products to patients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

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...

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...

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...

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.

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.

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.

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.

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.

Medical DevicesAugust 28, 2023

Could Your Company Benefit from FDA’s Q-Submission Program?

FDA’s approach to regulating medical devices can sometimes be confusing and overwhelming. Thankfully, there is a voluntary program, The Q-Submission Program, that device manufacturers (also called sponsors) can use to obtain FDA feedback during device development, submission review, or even prior to clinical study commencement.

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