FDA under fire:
Pared-down LDT Final Rule leaves unanswered questions

FDA has finalized its landmark proposed rule that will amend the definition of “in vitro diagnostic (IVD) products” in 21 CFR 809.3 to make explicit that IVDs are medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA), “including when the manufacturer of the IVD is a laboratory.”

Reimbursement Déjà Vu:
Lessons for AI/ML Medtech Founders from the Molecular Diagnostics Industry

Payers demand robust evidence that molecular diagnostics and AI/ML technologies demonstrate clear ability to improve overall patient health or healthcare economics even if the technologies themselves don’t directly deliver the final outcome. This disconnect between a technology's function and the desired long-term impact creates a hurdle for [innovators] to overcome when convincing payers of their value proposition.

Medical devices: new guidance for industry and notified bodies

Question-and-answer document clarifies regulatory requirements for devices used in combination with medicines.

ICYMI

UL Certification:
A Launchpad for Product Development Excellence

Embracing certification leads to enhanced product quality, innovation, and customer trust.

AHRQ Issues Guide To Help Digital Health Developers and Users
Advance Equity

The new equity guide provides implementation steps to help developers and users implement the AHRQ Digital Healthcare Equity Framework to ensure new technologies ameliorate, rather than exacerbate, inequities in health care.

CUE Health lays off entire staff

San Diego-based medical tech company, Cue Health, announced Monday that it is laying off its entire staff. Similar industry reports indicate a complete shuttering of operations.

PMCF implementation under EU MDR

Smridula Hariharan leads a team of medical writers who work on CEPs, CERs, PMS Plan, Post-Market Surveillance Reports, Periodic Safety Update Reports, Post-Market Clinical Follow-up Plan and Reports, for devices spanning a wide range of therapeutic areas. Here, she shares secrets to cost-effective PMCF strategies in the dynamic landscape of the European Medical Device Regulation (MDR).

The Essential Guide to Strategic Supplier Management for Medical Devices

Medical Device Supply Chain Struggles? Download our FREE guide and discover how strategic supplier management builds resilience for a reliable flow of critical devices. We delve into the industry's unique challenges – strict regulations, quality needs, and constant innovation.

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Addressing engineering challenges in point-of-care diagnostic devices

Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership

The ultimate guide to the EU MDR and IVDR GSPR, 2nd Edition

Crossing the eSTAR Chasm – The First MedTech Benchmark Report on FDA’s 510(k) eSTAR Mandate

5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

How redesign can help meet sustainability demands for medical devices

Please visit the newest MTI Resource Center
Post-Market Surveillance

The MTI Post-Market Surveillance Resource Center provides current news and information specific to maintaining medical device post market product quality & compliance. PMS is a critical component in achieving global Regulatory Excellence to ensure medical devices remain safe, effective, and reliable for end-users.

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