Articles From Our Expert Network
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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.
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Market Research: Demand For Dynamic Compression Devices Shifts Among Types
4/13/2022
The administration of pressure through a sleeve system, known as compression therapy, has been traditionally used to treat a variety of medical conditions, including lymphedema and deep vein thrombosis. This article discusses the market for such compression therapy, including pneumatic compression devices and mobile compression devices.
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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.
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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.
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FDA Seeks Public Comment On Quality Metrics Reporting Program
3/17/2022
The FDA recently announced it is soliciting comments on changes to its previously proposed Quality Metrics Reporting Program. This article shares which primary metrics the FDA intends to collect data on as well as the FDA's questions for input. The comment period ends June 7, 2022.
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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.
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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.
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The Clinical Trial Sponsor’s Roadmap To Avoid EMA (Cyber) Perdition
3/1/2022
Clinical trials are one of the sectors most vulnerable to cyberattacks. In the European Medicines Agency (EMA)'s Guideline on computerized systems and electronic data in clinical trials, the EMA goes beyond the traditional software validation and data integrity expectations. It sets requirements and expectations pertaining to user management and ongoing security measures.
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What’s The Role Of Intuition When Making QRM Decisions?
2/28/2022
In Part 1 of this 2-part series, this author explained how to effectively set up your quality risk management (QRM) program for pharma and medical devices. In this article, he explains how to implement that program. For such a numbers-based field, there is still an important role for using your intuition to make QRM decisions.
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FDA Proposes Guidance On Discontinuation Or Interruption Of Medical Device Manufacturing
2/21/2022
The FDA's draft guidance, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act, is accepting public comments through March 11, 2022. When the FDA concludes that there is, or is likely to be, a shortage of a device, then inspections as well as review of submissions may be prioritized and expedited to help mitigate or prevent shortages.