How to Better Prepare for Regulatory Requests and Minimize Impact.

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Date: Jan-Feb 2021
From: Medical Product Outsourcing(Vol. 19, Issue 1)
Publisher: Rodman Publishing
Document Type: Article
Length: 1,511 words
Lexile Measure: 1340L

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The pressure to increase efficiency in medical device development has been prevalent across the industry over the past year, especially with the intensified regulatory expectations. Many projects continue to experience delays during the submission process with governing bodies, particularly when responding to requests for additional information.

There is a great deal of time and resources invested with each submission to ensure the device is safe and effective. Still, not all submission packages provide supporting data in the way reviewers are looking for, leading to outstanding questions. Companies that identify trending preferences and consider regulatory expectations in earlier project phases can align their efforts and minimize delays from additional information requests.

Identifying Common Pitfalls

Requests for additional information are unique to each regulatory submission, governing body, and reviewer. Manufacturers should be familiar with the overarching patterns and apply these insights to their development processes. Governing bodies are always refining their review processes, but current expectations and key trends to be aware of include:

Evaluating devices throughout the entire lifecycle. As the EU Medical Device Regulation (MDR) continues to hold the industry's attention, so does its intent to monitor medical devices more closely throughout the entire product lifecycle. The enhanced formalization of post market surveillance (PMS) guidance further supports this effort to continue device monitoring after regulatory approval. Additionally, some reviewers have recently requested that companies demonstrate biocompatibility at the end of shelf life. Manufacturers should consider any material differences from a chemical standpoint, especially devices produced with polymers and elastomers, that could alter toxicity at the end of the lifecycle and put biocompatibility at risk.

Minimizing in vivo testing. European regulators are also paving the way when it comes to reducing in vivo testing. Any animal testing lacking a clear purpose or justification will raise questions from regulators. Ensure in vivo testing is only in the submission if necessary and, if so, pair in vivo evaluations with proper justifications.

Proving expert qualifications.

Credibility is one of the top priorities for regulators. Reviewers will often request CVs of any staff members conducting medical device evaluations to better understand the quality of the testing and submission. The expectation primarily pertains to toxicology experts, but a testing lab's experience is of growing interest and regulators may require this documentation for other...

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Gale Document Number: GALE|A652003852