By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    healthcare cybersecurity
    4 Helpful Tips on How to Protect Your Medical Practice Against Cyber Attacks
    October 24, 2021
    Health Check Diagnosis Medical Condition Analysis Concept
    6 Health Woes With Online Remedies
    January 19, 2022
    Eight Things Men Should Know About the Male Menopause
    Eight Things Men Should Know About the Male Menopause
    April 24, 2022
    Latest News
    Beyond Nutrition: Everyday Foods That Support Whole-Body Health
    June 15, 2025
    The Wide-Ranging Benefits of Magnesium Supplements
    June 11, 2025
    The Best Home Remedies for Migraines
    June 5, 2025
    The Hidden Impact Of Stress On Your Body’s Alignment And Balance
    May 22, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    healthy nursing school habits
    Healthy Habits for Nursing Student Nursing School Students
    May 24, 2024
    High Deductables
    High-Deductible Insurance and Rising Bad Debt
    July 24, 2015
    How People Are Taking Advantage of Health Deals in the Recent Recession
    February 5, 2021
    Latest News
    Top HIPAA-Compliant Messaging Apps for Healthcare Teams
    June 25, 2025
    When Healthcare Ends, the Legal Process Begins: What Families Should Know About Probate and Medical Estates
    June 20, 2025
    Preventing Contamination In Healthcare Facilities Starts With Hygiene
    June 15, 2025
    Strengthening Healthcare Systems Through Clinical and Administrative Career Development
    June 13, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: FDA Updates List of Recognized Standards, Confusion Ensues
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Technology > Medical Devices > FDA Updates List of Recognized Standards, Confusion Ensues
eHealthMedical DevicesNewsPolicy & LawTechnology

FDA Updates List of Recognized Standards, Confusion Ensues

Tim Gee
Last updated: September 5, 2013 8:11 am
Tim Gee
Share
6 Min Read
medical device standards
SHARE

medical device standardsOn August 6, 2013, FDA published modifications to the list of medical device related standards they recognize.

medical device standardsOn August 6, 2013, FDA published modifications to the list of medical device related standards they recognize. News was made of the fact that additions to the recognized standards addressed areas such as cybersecurity and interoperability. While there were many revisions and some additions of a variety of standards, this blog post will focus on the news making standards related to medical device connectivity.

The published modifications are divided between two separate recognition lists, number 31 (pdf) and 32 (pdf). Here is the Federal Register version (PDF). Recognition list number 31 includes one standard under the Software/Informatics category: Laboratory Automation: Data Content for Specimen Identification; Approved Standard (NCCLS AUTO-7A). The 20+ standards listed in recognition list number 32 are all new additions under Software/Informatics and focus on the following topics:

  • IT governance in hospitals for networked medical devices,
  • Medical device connectivity and interoperability, and
  • Cybersecurity

These are all great standards (although they are of varying relevance and usefulness). So where is the confusion, you might ask?

More Read

affordable care act mandate delay
The Unintended Consequences to States, Carriers and Consumers of the “Delay Option”
HIMSS 2013: Mayhem or Magic?
Medical Professionals: Protect the Online Reputation of Your Practice
HealthCare Social Media: What Makes Sense?
The Remarkable Health Advantages of Wearing Glasses Explained

Reading the stories linked above, this reader was left with the impression that FDA is encouraging or stipulating the use these standards and that by listing these standards, manufacturers can be expected to adopt the new listed standards. Sadly, this is not the case.

The intent of listing recognized standards (found in the FDA guidance on the Recognition and Use of Consensus Standards) is to “simplify and streamline” the premarket review process. Some standards, such as Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds…

[…] are often very useful when an FDA-recognized consensus standard exists that serves as a complete performance standard for a specific medical device. In these cases, the standard may include specific acceptance criteria that describe the relevant performance characteristics of that specific medical device. Conformity to the recognized standard should, in these cases, minimize the amount of data and documentation needed in the 510(k) submission to demonstrate substantial equivalence.

Such standards are a great boon if your medical device matches the standard, for example using polymeric tissue scaffolds. Unfortunately, there are relatively few comprehensive standards of this type. Most often, more general standards are used that do not encompass all aspects of device performance. In these cases, you cover what you can with the standard and provide what you judge to be sufficient objective evidence to justify the parts of your submission that are not covered by the standard.

If applied appropriately, conformance to other more general vertical standards (i.e., device specific standards that may not encompass all aspects of device performance) can also serve as a means to streamline the premarket review process. Conformance and declarations of conformance to any recognized consensus standard that clearly spells out acceptance criteria is a very effective use of standards in the premarket process. Used this way, conformity to FDA recognized consensus standards will reduce the amount of documentation that you need to submit and may allow FDA to reduce review time.

A common area of contention with premarket submissions to FDA is how good is good enough. Is your risk management process, and resulting objective evidence, sufficient? Is your method for determining the biocompatibility of your sensor adhesive sufficiently rigorous? These kinds of questions come up frequently in premarket submissions. Following and referencing appropriate standards accepted by FDA can remove that uncertainty.

What the guidance document doesn’t really get into are the various ways standards are used in medical devices and/or submissions. Standards can be used:

  • in a device’s product features to establish how a capability is implemented,
  • in a device’s specifications to communicate performance metrics and to use as a benchmark,
  • in processes to describe how something was accomplished, and
  • in testing criteria to demonstrate achievement of accepted performance, safety or effectiveness.

It is important to note that the use of any of the FDA recognized standards is purely voluntary on the part of the manufacturer. Perhaps a new product does not conform to a recognized standard because a novel approach was taken in an effort to develop a superior product. Such innovation be definition precedes the development of consensus standards. Or perhaps your human and physical resources are such that you arrived at your desired objective in a way that does not conform to the standard other manufacturers may have used. When established standards are not used, the onus is on the manufacturer to provide sufficient objective or scientific evidence that what was used was at least as safe and effective as the outcome of using the applicable standard.

There’s much more about the use of standards in regulated medical devices in the guidance. Important issues in the guidance include how to go about selecting which standards you want to use and the information to be included in a declaration of conformity. FDA even has a database where you can search for specific standards.

Also, be sure to visit the CDRH Standards Program web page.

(Medical device cybersecurity standards / shutterstock)
TAGGED:FDA
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

women dental care
What Is a Smile Makeover and How Much Does It Cost?
Dental health
June 30, 2025
HIPAA-Compliant Messaging Apps
Top HIPAA-Compliant Messaging Apps for Healthcare Teams
Global Healthcare Policy & Law Technology
June 25, 2025
recovering from injury
Rebuilding After Injury: Path to Physical and Emotional Recovery
News
June 22, 2025
scientist using microscope
When Healthcare Ends, the Legal Process Begins: What Families Should Know About Probate and Medical Estates
Global Healthcare
June 18, 2025

You Might also Like

News

AMA Votes to “Vigorously” Stop ICD-10

November 16, 2011

Observations on the PSA Testing Debate

October 12, 2011

The Dumb and Dumber Files–Man Faked Arm Amputation On Dismemberment Insurance Claim Sentenced to 57 Months in Jail

August 23, 2011
BusinessMedical Ethics

Drug Marketing and Data Mining: Free Speech or Free Ride?

January 30, 2012
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?