Medtech Matters

An Early Look at FDA’s Guidance Focus for 2027, Part 1

An Early Look at FDA’s Guidance Focus for 2027, Part 2

A Preview of MDUFA VI: Changes and Highlights, Part 2

MDUFA VI shifts the regulatory focus from further reducing review times—which have reached a practical limit—toward improving the quality and specificity of FDA feedback. Major deficiency letters for Class III PMAs and additional information requests often lack actionable detail, a trend exacerbated by high turnover an...

A Preview of MDUFA VI: Changes and Highlights, Part 1

MDUFA VI, the upcoming iteration of the Medical Device User Fee Act, aims to refine the regulatory landscape for medical devices by introducing new fee structures and procedural changes. A central development involves a proposed $2,000 fee for pre-submissions, intended to reduce misuse of the process by unprepared appl...

The Value in Partnering for Sterility Testing

Sterility testing serves as a critical component of medical device safety, requiring a nuanced approach based on whether a product undergoes aseptic processing or terminal sterilization. While USP-71 governs aseptic processes, ISO standards typically apply to terminally sterilized products. Manufacturers often outsourc...

ECRI's 2026 Top 10 Health Technology Hazards

Measuring Regulatory/Quality Team Member Performance

FDA's Third-Party Review Program

Triaging Your QMS: Considerations Based on the New QMSR

A Deep Dive into E&L and Biocomp Testing

Planning for FDA Shutdowns Now and in the Future

Should Wellness Products Come with a Warning?

3 Most Common Premarket (Postmarket?) Review Issues FDA Sees

Why Are One-Third of MAUDE Reports a Problem?

FDA Guidance on Off-Label Communication, Part 1

FDA Guidance on Off-Label Communication, Part 2

Development Considerations for Over-the-Counter Medtech, Part 1

Development Considerations for OTC Medtech, Part 2

Device Descriptions in Regulatory Submissions

Regulatory Ramifications Due to the Presidential Election