ARTICLES BY MARK DURIVAGE

• FDA Seeks Comment On Delaying, Denying, Limiting, Refusing Inspections

  1/9/2023

  The FDA has released for public comment a proposed draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1. The guidance shares examples of reasonable and unreasonable circumstances. Submit public comments by February 14, 2023.

• FDA Seeks Comment On Conducting Remote Regulatory Assessments

  8/11/2022

  The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.

• The Voluntary Improvement Program: FDA Seeks Public Comment On Draft Guidance

  6/6/2022

  The FDA seeks comments on its proposed guidance describing its policy regarding FDA's participation in the Voluntary Improvement Program. The program is facilitated by the Medical Device Innovation Consortium. Comments are due by July 5, 2022.

• MDSAP Audit Approach Updated From Rev. 6 To 7

  6/2/2022

  On April 15, 2022, MDSAP Audit Approach AU P0002.007 was updated from version 006 to 007. This article summarizes the changes important for medical device manufacturers to know.

• 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. 

• 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.

• 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.

• FDA Issues Proposal To Amend The Medical Device Quality System Regulation

  2/24/2022

  The FDA is proposing to amend the current good manufacturing practice (cGMP) requirements of 21 CFR Part 820: Quality System Regulation (QSR) to align more closely with the requirements of the internationally recognized ISO 13485:2016. The proposed amendment will also affect 21 CFR Part 4: Regulation of Combination Products.

• 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.

• EMA Publishes Guideline On Quality Documentation For Medicinal Products

  8/2/2021

  This new EMA guideline will become effective on January 1, 2022. It describes the information that should be presented in the quality part of a marketing authorization dossier for a medicinal product when it is used with a medical device and/or as part of a medical device. Medicinal products are similar to "combination products" referred to by the US FDA.