Regulatory & Compliance Perspectives

1. EU MDR’s Benefit-Risk Ratio: Making Your Clinical Evaluations Safety-Focused 5/13/2022

   The EU's Medical Device Regulation refers to a benefit-risk ratio multiple times, especially with respect to clinical evaluation and in Sections 1 and 8 of Annex I. However, no universally accepted method exists for calculation of such a ratio. This article proposes a method for calculating it in the spirit of focusing on patient safety and the ability to track changes in the safety profiles of products.

2. 21 CFR 820's New Terminology & Country-Specific Terms For Medical Device Quality 4/25/2022

   The proposed revision to the U.S. Quality System Regulation (aka 21 CFR Part 820) takes a giant leap toward harmonization with other major global medical device regulations, but some U.S.-specific terms and requirements will remain in effect. This article shares the details and also discusses the impact on inspections.

3. 5 Key Steps For FDA Q-Submissions 4/18/2022

   Most medical device designers and developers have some familiarity with the FDA's Q-Submission Program. Relatively few, though, know how to best use the program to effectively speed the product development process and, ultimately, get their devices to the market sooner. Follow these 5 steps for speedier time-to-market than your competition.

4. FDA Issues Guidance On Initiation Of Voluntary Recalls 4/5/2022

   This guidance supports the requirements of 21 CFR Part 7 Enforcement Policy for drugs, medical devices, and biological products, and is being issued consistent with FDA's good guidance practices regulation. You may submit comments regarding this guidance to the agency at any time. 

5. Peru’s Growing Medical Device Market In Latin America 4/4/2022

   With a population of 32 million, Peru is the fifth most populous country in Latin America. Its medical device market is $390 million, and it imports more than 97% of the medical devices that it uses. This article covers Peru's health system, its medical device regulatory framework, and opportunities for medical device imports.

6. How Do I Need To Update My QMS For FDA QMSR Amendment Compliance? 3/23/2022

   The FDA has officially announced its intention to harmonize and modernize 21 CFR Part 820 Quality Management System Regulation (QMSR) for medical devices. This article describes what you need to do with your QMS in order to meet compliance.

7. The Large Market For Medical Devices In Colombia May Surprise You 3/21/2022

   Colombia has a population of approximately 50 million inhabitants, making it the third most populous country in Latin America after Mexico and Brazil. This article covers the general Colombian health social security system, the current medical device regulatory framework, and the size and trends of the market.

8. Medical Device Packaging Labels 101 3/16/2022

   Medical device labels play an important role in a device’s life. They are key to market introduction and success, a company’s long-term financial viability, and to patients’ health and lives. This article provides advice for getting the label right the first time to avoid product recalls and for the best chance of product success.

9. FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations 3/8/2022

   Increasingly, digital health technologies are becoming part of the conduct of clinical trials. They cover a broad range of applications, including ingestible and implantable sensors, wearables, electronic signatures on consent forms, and more. This article summarizes the key takeaways of the FDA's new draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. The public comment period ends March 22, 2022.

10. What Does EN ISO 14971:2019’s New Amendment Mean For Harmonisation? 3/4/2022

    CEN, the European standards body, recently released an amendment to the European edition of the medical device risk management standard, EN ISO 14971:2019, amendment A11:2021. This article examines the amendment and discusses what this means with regard to harmonisation with the MDR and IVDR regulations in Europe.