Abstract
For medical device companies that are required to comply with regulatory requirements, making a mistake can be costly. There is immense value in being proactive and cautious by looking for potential pitfalls and taking steps to avoid or mitigate regulatory issues before they can become regulatory problems. Keeping organized, up-to-date and well-documented are all good practices for achieving and maintaining compliance. Further, being prepared for FDA inspections by conducting periodic internal reviews and audits will go a long way toward reducing a company’s risk of being noncompliant. Remember that changes are inevitable in the medical device industry, but stay flexible—plans will change, official guidances will be updated, and regulations and laws will be revised. Taking action immediately to address changes and to address any other noncompliance issues will be the best course of action for a medical device company to avoid and prevent regulatory problems.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsReference
FDA Guide to Inspections of Qualify System, Aug. 1999, available online at https://www.fda.gov/downloads/ICECI/Inspections/InspectionGuides/UCM085938.pdf (accessed Aug. 21, 2018).
Author information
Authors and Affiliations
Rights and permissions
Copyright information
© 2019 Springer Nature Switzerland AG
About this chapter
Cite this chapter
Halt, G.B., Donch, J.C., Stiles, A.R., VanLuvanee, L.J., Theiss, B.R., Blue, D.L. (2019). Tips for Avoiding and Preventing Regulatory Problems. In: FDA and Intellectual Property Strategies for Medical Device Technologies. Springer, Cham. https://doi.org/10.1007/978-3-030-04462-6_16
Download citation
DOI: https://doi.org/10.1007/978-3-030-04462-6_16
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-030-04461-9
Online ISBN: 978-3-030-04462-6
eBook Packages: EngineeringEngineering (R0)