February Tip: Managing Updates to Regulatory Documentation

2018-bl-gxp-lifeline-regulatory-manager-page-imageEDITOR’S NOTE: This is the first of a two-part series on Regulatory Manager’s tips to successfully managing updates to regulatory documentation as part of the Regulatory Manager Tip of the Month series.

Part 1—Changes that likely don’t require a new submission, but do cause updates to regulatory submission documentation.

Tip: When the change occurs, review the current regulatory submission(s) and note where updates are needed. Even better, create a working or dynamic version of an updated submission.

It’s no secret that design and manufacturing changes produce a significant number of updates to current documentation. And sometimes, the creation of new documentation entirely. When a change triggers an update to a document that was included in a regulatory submission already approved or cleared by regulatory authorities, all future submissions for that product will need to reflect the current state of the product and its respective documentation. The current state of the product consists of the current documentation. 

The more straight forward situation to manage is when the particular design or manufacturing change at hand is significant enough to necessitate a new regulatory submission. 

The situation we will discuss in this article is the more challenging one to manage—when the particular design or manufacturing change at hand is not significant enough to require a new regulatory submission, but the current submission for that product does include (the now obsolete version of) the updated documentation.

Keeping the submission documentation updated, even when a new submission is not yet required, is necessary to enable the success of future submissions and license renewals.  More importantly, failing to keep the regulatory submission documentation updated will considerably hinder the success of future submissions and license renewals.

Here is a quick guide to the regulatory submission documentation typically impacted by predictable design and manufacturing changes that are unlikely to necessitate a new regulatory submission.   

This article is related to the Product Data Sheet:
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When these changes happen, be sure to review the current regulatory submission(s) and note where updates are needed.  Even better, you can create a working or dynamic version of an updated regulatory submission.

Regulatory Submission Documentation Key

1 - Product Labels   2 - Instructions for Use   3 - User Manual   4 - Sterilization  Information
5 - Device Description    6 - Packaging Information   7 - 510(k) Summary/Statement   8 - Engineering Drawings
9 - Indication for Use   10 - Substantial Equivalence   11 - Shelf Life Information   12 - Biocompatibility
13 - Performance Testing   14 - Clinical Testing   15 - Electrical Safety / EMC   16 - Literature
17 - Software Documentation   18 - Human Factors/Usability              19 - Summary/History of Product Changes    


Examples of Labeling Changes

Potentially Impacted Regulatory Submission Documentation

Change from reusable device to single-use device

1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 18, 19

Clarify the indication for use

  • Without affecting the substance or meaning
  • To limit use within the currently cleared indication
  • Solely to clarify or improve readability

1, 2, 3, 5, 7, 9, 10, 19

Change from over-the-counter to prescription use only

1, 2, 3, 5, 7, 9, 10, 18, 19

Change the intended user to a user with similar training

5, 7, 9, 10, 18, 19

Expanding compatibility with another device that is already labeled for use with the subject device, or with the same device type

1, 2, 3, 5, 7, 9, 13, 18, 17, 19

Change a warning or precaution based on user experience information

1, 2, 3, 14, 16, 18, 19


Examples of Technology or Performance Changes

Potentially Impacted Regulatory Submission Documentation

Cleaning, disinfection, or sterilization changes that do not significantly affect performance or biocompatibility

2, 3, 4, 5, 7, 10, 19

Packaging changes that use the same methods or protocols described in the current submission

5, 6, 7, 8, 11, 13, 18, 19

Expiration dating changes that use the methods or protocols described in current submission

1, 4, 5, 6, 7, 10, 11, 13, 19

Dimensional changes within the previously cleared range

5, 7, 8, 13, 18, 19

Design change for user/patient comfort without changing the way the device functions or performs

2, 3, 5, 7, 8, 13, 18, 19

Change to facilitate use in a different, but similar, environment

1, 2, 3, 5, 11, 13, 19


A good regulatory manager will implement effective methods for handling changes in regulatory documentation. This allows an accurate assessment of the cumulative impact of product changes. A great regulatory manager will use these methods when changes occur, regardless if the change itself necessitates a new regulatory submission. Specific techniques may include pre-authoring the submission where possible, to permit “drop-in” of controlled documents. 


2018-bl-author-tamara-burchTamara Burch-Williams is a clinical research and biologics professional with over 10 years of experience in research and development, clinical manufacturing, laboratory testing, and infectious disease. She has business process expertise in pharmaceutical and biopharmaceutical integrated services and their respective industries.

Prior to directing her skills to work with technology solutions and services providers, Tamara worked for world-renowned pharmaceutical companies, including Merck, and for private CRO and CMO companies, as well as non-for-profit organizations such as the American Red Cross National Testing Laboratory.

Tamara currently operates as an implementation manager with Professional Services at MasterControl, Inc., where she works with product management, systems development, and services teams to advance solutions designed for the pharmaceutical industry that focus on clinical operations, clinical quality and regulatory affairs.

Prior to joining MasterControl, Tamara cultivated her expertise in clinical, regulatory, and industry disciplines by serving in a variety of professional positions such as a technologist, product manager, production manager and operations manager.