Regulatory & Compliance Perspectives

1. AI Enters The 510(k) Submission World: What Device Developers Need To Know 12/15/2025

   The FDA’s implementation of AI tools marks the next step in the agency’s digital transformation efforts. Let's take a closer look at how this impacts 510(k) submissions and tips for preparing your submissions.

2. Unpacking The EU's Mutual Recognition Agreements For Pharma 12/12/2025

   MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.

3. The U.K.'s MHRA Adds New Guidance To The Changing Regulatory Landscape For Digital Mental Health Technologies 12/12/2025

   The U.K. MHRA’s newly released framework offers long-awaited clarity by outlining when digital mental health technologies qualify as medical devices based on their intended purpose and functional impact. 

4. Wearable Medical Devices — What Should Your Contracts Look Like? 12/1/2025

   Discover from Leibowitz Law how to embed compliance and contractual protections into your wearable device contracts from the outset.

5. Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations 11/18/2025

   A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

6. Duty Of Disclosure Considerations For Medical Device Patent Applicants With Parallel FDA Submissions 11/12/2025

   Understanding the crucial overlaps between FDA disclosures and patent law is important for medical device innovators seeking to protect their intellectual property.

7. A Better Interpretation Of POH In ISO 24971 11/3/2025

   Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.

8. The Balkan Puzzle: Using Non-EU States As A "Pre-MDR" Proving Ground For Your Device 10/3/2025

   The EU's Medical Devices Regulation (MDR) has introduced a new level of rigor. A sophisticated, yet practical, strategy is emerging: leveraging non-EU Balkan countries as a "pre-MDR" proving ground. 

9. EU MDR: When Products Without An Intended Medical Purpose Meet Medicinal Substances 9/24/2025

   One major change introduced by the EU MDR compared to the former European directives is the inclusion of products without an intended medical purpose but with similar risk profiles to medical devices, such as dermal fillers.

10. RFK Jr. Wants Every American Wearing A Wearable. How Can Pharma Build A Business Around It? 9/16/2025

    The timing is now for pharma to be all-in on using wearables as their new business strategy, says Digital Medicine Society (DiMe) Director of Partnerships Smit Patel, PharmD.