5 Regulations You Need to Know About Medical Devices in 2016

Posted By  |  April 14, 2016


Medical device distribution is a highly-regulated industry, with many regulations and rules that must be adhered to. Here are the top 5 regulations medical device distributors should be aware of for 2016.

The top 5 #medicaldevice regulations you should be aware of for 2016 + what’s in the works via @aplicor http://apli.fyi/1SbBGt0Tweet: The top 5 #medicaldevice regulations you should be aware of for 2016 + what’s in the works via @aplicor http://apli.fyi/1SbBGt0Tweet This!

The Food and Drug Administration (FDA) worked diligently over the last six months on various regulatory matters. Here are a few of them:

  • If you work with Class II devices, you will be glad to know that the FDA will now accept account requests from labelers under the Global Unique Device Identification Database (GUDID). The FDA suggests that applicants visit its online GUDID preparation and UDI training
  • The FDA clarified the medical device types that require human factors testing data during the FDA reviews because of the “clear potential for serious harm resulting from use error.” The FDA issued the draft list of highest priority devices for human factors review in order to solicit industry comments. When finalized, the document will represent the FDA’s current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind the FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
  • At the end of February 2016, the FDA issued a notice asking insurance and health technology companies to submit expressions of interest in providing input with respect to medical device clinical trial designs and private payer coverage.
  • The FDA issued guidance on its acceptance standards for electronic copies of medical device submissions, including requirements for cover letters, volume submitter versus non-volume submitter submissions, adding PDF files and adding non-PDF files.
  • On January 22, 2016, the FDA issued draft guidance entitled, “Postmarket Management of Cybersecurity in Medical Devices.”The FDA says it encourages medical device manufacturers to address cybersecurity during design, development, production, distribution, deployment and maintenance. As the number of networked medical devices grows, like other networked computer systems, the incorporated software will increase the devices’ vulnerability to cybersecurity threats.


The “A” List – Will Publish

The Center for Devices and Radiological Health (CDRH), a branch of the FDA, says that it has prioritized medical device guidance for 2016 on what it refers to as the “A” list.

CDRH anticipates the following final regulations will issue from this list in 2016:

  • Policy for Regulatory Oversight of Laboratory Developed Tests (October 2014 draft)
  • Unique Device Identification (UDI) Direct Marking (June 2015 draft)
  • Medical Device Accessories
  • Benefit-Risk Factors to Consider when Reviewing IDE Submissions
  • Adaptive Design for Medical Device Clinical Studies
  • Incorporating Patient Preferences into Medical Devices Premarket Approvals, Humanitarian Device Exemptions, and De Novo Classifications
  • Applying Human Factors & Usability Engineering to Optimize Medical Device Design
  • Submission and Review of Sterility Information for Devices Labeled as Sterile
  • Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing (Biocompatibility)
  • Medical Device Reporting (MDR) for Manufacturers


CDRH also anticipates issuing draft guidance on the following topics:

  • Medical Device Decision Support Software
  • Use of Symbols in Labeling
  • 510(k) Modifications
  • Software Modifications
  • 510(k) Third Party Review Program
  • Companion Diagnostics Co-Development
  • Use of Real-World Observational Patient Data to Support Decision Making for Medical Devices
  • UDI Convenience Kit
  • Public Notification of Emerging Postmarket Medical Device Signals


A “B” list of regulatory matters includes topics that the FDA may address in 2016 if they have the funds and resources to do so. Historically, the FDA does not complete the list of topics it anticipates covering each year.

In addition, the progress of several proposals in Congress bear watching as they would change the FDA medical device pre-market reviews and clinical trial requirements.

The regulatory environment of medical device/pharmaceutical distribution makes it imperative to have the right business applications in place to ensure your data is accurate and your business runs smoothly. To learn how Aplicor’s medical device distribution software can help, please contact us.