Guest Columns

  1. The Safety and Performance Based 510(k): A New Pathway for Regulatory Submission

    Under the umbrella of the Abbreviated 510(k) program, the Safety and Performance pathway has a very specific and limited scope that aligns with FDA’s substantial equivalence and least burdensome provisions: conformity with performance criteria.  

  2. ISO 13485 Medical Device Quality System Standard And Other Regulatory Conundrums

    ISO 13485 is up for periodic review, and the ISO Technical Management Board has indicated that standard should be revised to comply with the new High-Level Management System Structure (MSS) for all documents of this type. The 2015 version of ISO 9001 is in the new structure, and it is organized in a vastly different format. 

  3. FDA Guidance On Premarket Pathways For Combo Products — What It Does (And Doesn’t) Say

    Last month, the FDA published the draft guidance “Principles of Premarket Pathways for Combination Products.”  The document describes what a combination product is and how to interact with the FDA when developing a combination product, and it identifies some of the principles the agency uses in determining what type of premarket submission should be made. 

  4. How The FDA’s Pre-Certification Pilot Program Is Paving The Way For AI In Medtech

    The FDA’s Software Precertification (Pre-Cert) Pilot Program aims to move away from the traditional 510(k) and De Novo pathways, and to develop a program better suited for technologies that have a rapid development and update lifecycle.

  5. Raising The Bar: The Silver Lining Of FDA Commissioner Gottlieb’s Exit

    It was the announcement many have been dreading — but expecting — for several months now. Dr. Scott Gottlieb, 23rd Commissioner of the FDA, announced his decision to step down after 663 days (22 months) on the job. The news is sure to raise concerns for many. But I think the biggest surprise is how equally sad thought-leaders within the agency will be to say goodbye.

  6. Guidelines For Mobile Health Applications – Examining The Xcertia Guidelines’ Initial Release

    How does this new set of guidelines promote more thoughtful development of mobile health applications (mHealth apps), and how can you weigh in?

  7. Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis

    When SMEs, management, and others gather to perform a risk assessment or a root cause analysis on a failure, they’re sure to achieve the desired outcome, right? Perhaps for a simple risk assessment or investigation, but success is not very likely for one that is even moderately complicated. That’s where a skilled facilitator is needed.

  8. Bridging Chasms In Equipment Qualification And Software Validation

    Equipment qualification seems like a straightforward process. However, things usually go awry when gathering a validation team and defining and documenting the intended use and system requirements. 

  9. Solving Problems More Effectively Than Sherlock Holmes: The Contradiction Matrix

    This is the fourth article in a five-part series on better investigation and problem-solving methods and principles in the life sciences. In writing this one, I’ve been thinking quite a bit about Sherlock Holmes. Not only his exquisite methods, but also flaws in the metacognition and metaphilosophy about how the fictitious detective underwent his work.

  10. 3 Challenges To The Orthopedic Biomaterials Market In 2019

    Despite declining prices, technological innovation and other developments in the orthopedic biomaterial product market have maintained the market’s growth, drawing in patients with easier-to-perform and more efficient procedures.