FDA's CDRH posts list of proposed guidance development in 2016 as well as final guidance to be reviewed

Daphne Allen

January 6, 2016

4 Min Read
FDA's CDRH posts list of proposed guidance development in 2016 as well as final guidance to be reviewed
Photo source: iStock/AlexLMX

FDA's Center for Devices and Radiological Health has posted a list of the guidance documents it plans to publish in fiscal year 2016 as either final or draft guidances. It has also posted a list of previously issued final guidances for which the center is interested in receiving external feedback on whether they should be revised or withdrawn.

Several of these guidances could be of interest to medical device packaging professionals. CDRH asks that comments on any of these guidance documents be submitted to docket FDA-2012-N-1021.

FDA has divided the potential guidance documents that could be published as either final or draft into an "A" list and a "B" list. The A list is a "list of prioritized device guidance documents that the Agency intends to publish within 12 months of the date this list is published each fiscal year," whereas the B list is a "list of device guidance documents that the Agency intends to publish as resources permit each fiscal year," FDA explains.

Below is just a partial list of these guidances, posted here by PMP News because of their potential relevance for packaging professionals. Please note that FDA has listed several more guidances than included below, so please do view the entire list by clicking here.



Final Guidance Topics
  • Medical Device Accessories

  • UDI Direct Marking

  • Applying Human Factors & Usability Engineering to Optimize Medical Device Design

  • Submission and Review of Sterility Information for Devices Labeled as Sterile

Draft Guidance Topics
  • Use of Symbols in Labeling

  • 510(k) Modifications

  • UDI Convenience Kit


Final Guidance Topics
  • Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use

  • Self-Monitoring Blood Glucose Meters for Over-the-Counter Use

Draft Guidance Topics
  • Patient Access to Information

  • Defining the Unique Device Identifier (UDI)

Guidance documents subject to CDRH’s focuses retrospective review during FY2016

1996 Final Guidances

2006 Final Guidances

Speakers at MD&M West (Feb. 9-11; Anaheim, CA) will cover regulations (but not necessarily those to which the above guidances pertain) in the following sessions:

Wednesday, February 10

10:00 am - 11:45 am
Regulatory Boot Camp for Medical Device Companies

  • Gaining insight into the different US and OUS regulations that govern drug and medical device companies

  • Better understanding the 510K submission process and it’s applicability for your products

  • Discussing hot topics in regulatory health pertaining to digital health, combination products, and other product families

David Amor, MSBE, CQA, RAC, Principal, MEDGINEERING, INC.

Thursday, February 11

10:30 am - 11:30 am
Process Validation Planning: Have You Made the Leap into the 21st Century?

  • Defining the regulatory definition of process validation and why it’s important to managing your risk management program

  • Why it’s important to understand the application of the 2011 FDA PV Guideline

  • How changes put forth in the guideline require you to move from IQ/OQ/PQ to process capability and control mode (P&PC)

  • Addressing the main issues the industry continues to struggle with daily (i.e. device safety, design control, software systems, training, etc.)

  • Reviewing process validation difficulties from both a small and large company perspective

Walt Murray, Director of Quality & Compliance Services, MASTERCONTROL

2:45 pm -3:30 pm
Panel: Combination Product Development FDA Submission Challenges and Opportunities

  • Understanding trends in innovative combination products and priorities of larger industry players

  • How do you classify a combination product and what submission pathways are necessary for your combination device?

  • Best practices in identifying and developing combination products including review of Requests for Designation (RFD)


James Wabby, Director, Regulatory Intelligence and Strategic Compliance, ALLERGAN
David Amor, MSBE, CQA, RAC, Principal, MEDGINEERING, INC

3:30 pm - 4:00 pm
Developing a Robust Combination Product Quality Management System

  • Considerations for determining how to prepare for a combination product quality management system

  • Discussing combination product quality system applications and controls

  • Discussing the importance of human factors engineering and usability

David Amor, MSBE, CQA, RAC, Principal, MEDGINEERING, INC.

Please click here for more details on attending MD&M West 2016.

About the Author(s)

Daphne Allen

Daphne Allen is editor-in-chief of Design News. She previously served as editor-in-chief of MD+DI and of Pharmaceutical & Medical Packaging News and also served as an editor for Packaging Digest. Daphne has covered design, manufacturing, materials, packaging, labeling, and regulatory issues for more than 20 years. She has also presented on these topics in several webinars and conferences, most recently discussing design and engineering trends at IME West 2024 and leading an Industry ShopTalk discussion during the show on artificial intelligence.

Follow Daphne on X at @daphneallen and reach her at [email protected].

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