Reimbursement in Spine: A NASS Priority
In order for commercialization to succeed, everyone needs to be paid. Be proactive for you and your customers by making...
Sep 07 2016,
Regulations
Resubmitting a 510(k) is More Than a Regulatory Decision
Do changes to your device warrant a 510(k) submission? There are several elements to consider: design controls compliance, risk analysis...
Sep 07 2016,
Making the Most of UDI
UDI regulations have altered your business. Gaining solid ROI from your compliance efforts comes down to internal efficiency, capturing your own...
Aug 04 2016,
FDA Guidance Outlines How to Create a Unique Device Identifier
FDA recommends companies reexamine UDI basics with new draft guidance on how to form a proper identifier....
Jul 26 2016,
How to Register Your Device in Australia
This article provides a high-level view of how a company can enter the Australian market and leverage their CE Marking...
Jul 13 2016,
3 Points to Consider from the Long-Awaited EU Medical Device Regulations
The new EU Medical Device Regulations could make it tougher for orthopaedic device manufacturers to do business in Europe. ...
Jul 11 2016,
Third Party Reviews – Is This the Real Deal?
Companies with simpler products like arthroscopes and surgical instruments could consider a regulatory route that doesn't start with FDA and...
Jun 23 2016,
Trade Secrets Go Federal
Passage of the "Defend Trade Secrets Act" (DTSA) federalized the trade secret law. One of the key aspects of DTSA...
Jun 23 2016,
Invibio Settles FTC Antitrust Allegations Concerning PEEK Market
Invibio, the first company to sell implant-grade polyetheretherketone or PEEK, agreed to settle Federal Trade Commission (FTC) charges that it...
May 25 2016,
FDA Issues Draft Guidance on Additive Manufactured Devices
FDA published draft guidance on technical considerations for additive manufactured devices in response to the technology’s advancements and investments. Among...
May 24 2016,
Supplier Quality Agreements Are Not Just a Handshake Anymore
Regulatory bodies do not see supplier quality agreements as a new requirement. They also expect medical device manufacturers to require...
Apr 22 2016,
FDA Releases UDI Education as Deadline Approaches
FDA released a series of resources to help companies understand GUDID submission, UDI labelling regulations and compliance schedules. The resources...
Apr 12 2016,
FDA Releases Final Guidance on Human Factors and Usability Engineering
The Agency released the final guidance on considerations for human factors data in premarket submissions, as well as two draft...
Apr 12 2016,
Proving Medical Necessity: the Need for Evidence in Reimbursement
Providers, OEMs and suppliers all say that they’ve been impacted by complexities in the reimbursement system. For example, bundled payments...
Mar 23 2016,
New Guidance for UHMWPE Submissions
FDA recently released draft guidance outlining new information companies must include when submitting devices with Ultra High Molecular Weight Polyethylene...
Feb 23 2016,