FDA Addresses Custom Device Exemptions
FDA clarified changes to the Custom Device Exemption provision through a final guidance document....
Nov 07 2014,
Regulations
FDA Seeks 21st Century Agility with 510(k)s
FDA introduced several changes, including new initiatives to clarify the 510(k) submission process. How will these changes affect your device’s...
Oct 02 2014,
Can I Make, Use and Sell My Patented Invention? The Answer May Surprise You
Obtaining a patent does not always guarantee the ability to build and commercialize your invention. Follow these tips to avoid...
Oct 02 2014,
FDA Publishes Q&A on UDIs
The deadline for Unique Device Identifier (UDI) implementation for medical devices is September 24, 2014. FDA has issued a 14-page...
Sep 10 2014,
Experts Offer Strategies for Clinical Trial Execution and Outsourcing
Experts share their insights on best practices and strategies for conducting clinical trials inside and outside of the U.S., as...
Sep 09 2014,
FDA Clarifies Substantial Equivalence Requirements for 510(k) Submissions
FDA attempts to clarify substantial equivalence requirements in its latest 510(k) guidance. What do these changes mean for your next...
Sep 09 2014,
Choosing Materials in a Shifting Global Regulatory Environment
Orthopaedic device manufacturers face increasing pressures related to the safety of raw materials used in implants and instruments. Consider these...
Aug 05 2014,
Effective Tools for Patent Searches
Management has given the go-ahead to design a new device. As an engineer, you’ll now conduct a patent search to...
Jul 09 2014,
The Starting Line: Turning the Corner with a Device Concept
New orthopaedic device concepts from surgeon entrepreneurs and novice inventors often hit snags when facing the reality of the regulated...
Jul 08 2014,
Protecting Inventions and Brands: IP Due Diligence in the Product Development Process
The importance of IP due diligence is often overlooked when bringing an orthopaedic device through each of the eight stages...
Jun 03 2014,
UDI Implementation: What are Your Next Steps?
Creating a playbook or strategic plan is an absolutely necessary step of UDI implementation. The major components of your plan...
Jun 03 2014,
Sunshine Act and Beyond: Improving Compliance
A crucial component of the new regulatory environment is adherence to the Physician Payment Sunshine Act, requiring manufacturers to report...
May 07 2014,
Design Controls: A 17-Year Learning Curve
Developing a new device and introducing it into production are very complex tasks. Thorough planning, process control and design controls...
May 07 2014,
FDA Expectations: Overcoming Supply Chain Weaknesses
FDA expectations of supplier management will continue to evolve as pressures are applied to the agency, device recalls are issued...
Apr 24 2014,
Sterilization: How to Validate Novel and Non-Traditional Processes
Novel and non-traditional sterilization processes offer alternatives that enable manufacturers to consider new polymer materials that are not compatible with...
Apr 11 2014,