RAPS Unwrapped

I’ve just returned from RAPS’ 2016 Regulatory Convergence conference in San Jose, Calif. This year marks the 40th anniversary of RAPS’ formation to help establish the regulatory profession as a critical and distinct discipline. Today RAPS is known for bringing together regulatory industry experts and thought leaders to exchange ideas, examine trends, and explore best practices. This year’s Convergence was no exception.

Here are some key takeaways that I found particularly interesting as we look ahead to 2017:

New UDI Requirements: Are You Ready?

In 2013, FDA released a final rule establishing a unique device identification (UDI) system designed to adequately identify devices through distribution and use. On September 24 UDI Requirements went into effect for Class II medical devices, including:

  • The labels and packages of class II medical devices must bear a UDI. § 801.20.
  • Dates on the labels of these devices must be formatted as required by § 801.18.
  • Class II stand-alone software must provide its UDI as required by § 801.50(b).
  • Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
  • Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.

During a RAPS workshop we learned that an industry survey has shown that the most difficult part of UDI compliance is the re-design of the labeling/packaging and updating the labeling system. The survey also showed that as of March 2016 only 62% of manufacturers were ready for FDA inspection of their UDI system.

This is precisely the kind of thought leadership that Beaufort can offer medical device manufacturers. We have the technical and operational experience to navigate the landscape of medical device regulatory changes and challenges including implementation of the new UDI requirements.

The Common Rule for the Protection of Human Subjects: Big Changes Ahead

In my opinion, the most important topic discussed for IVD manufacturers was the state of using leftover human specimens in IVD device studies.

Upcoming changes to the Common Rule for the Protection of Human Subjects could have a big impact. Under the new proposed rule, informed consent (IC) rules would become significantly tighter where IC would need to be sought for using leftover specimens for future clinical research.

Further, the new In Vitro Diagnostic Regulations (IVDR) in the European Union, set to be published in late 2016 or early 2017, also will propose big changes to informed consent. Under the proposed regulations, if patients withdraw their consent, not only will manufacturers need to discard the sample, but they also will need to remove that patient’s data from all data sets, publications and submissions.

These new rules will put bigger burdens on IVD manufacturers, making prospective studies more of the norm, even for Class II IVD studies. Now more than ever medical device manufacturers should seek guidance from third party resources to help alleviate this burden. At Beaufort we do this by developing regulatory strategies that address both industry-wide changes and the unique needs of our clients.

Preclinical Studies: Bring in Regulatory Professionals Early and Often

I was amused when one of the workshop speakers equated regulatory affairs professionals to “traffic cops”—but they were right. An RA professional can assist with preclinical planning and design by having proactive interactions with regulatory agencies and prompt consultations with you throughout the entire IVD development process. To gain maximum value from the data that can strengthen your submission and even reduce timelines and budget, bring in Regulatory Affairs into the process early and often.

Clinical and Regulatory Affairs Manager

Melissa Barhoover, PhD, RAC, is clinical and regulatory affairs manager at Beaufort with nearly 20 years of experience in developing and managing strategies for successful research and product development.

Date posted: September 29, 2016

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