GxP Lifeline
February Tip: Managing Updates to Regulatory Documentation
EDITOR’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.
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
| 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.
Tamara 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.
