FDA and Industry Reach Agreement in Principle on Medical Device User Fees
Under a user fee program, industry agrees to pay fees to help fund a portion of the FDA’s device review...
Mar 12 2012,
Regulations
The Anatomy of a Warning Letter, Part One: A Primer
This is the first of two articles dealing with the dreaded Food & Drug Administration (FDA) Warning Letter. This first...
Mar 12 2012,
An Introduction to Patent Opinions
Whenever a medical device company develops a new product, process or technology, the topic of getting an “opinion” inevitably arises....
Mar 12 2012,
510(k) Clinical Data Requirements: Current Status and Considerations for Clinical Studies
In an effort to promote innovation while protecting the population at large, the US Food and Drug Administration (FDA) has...
Mar 12 2012,
IP Portfolio Management Strategies for Medical Device Manufacturers
Management of a company’s intellectual property (IP) is all about two things: controlling the innovation produced by the Research and...
Dec 14 2011,
Planning for the Unpredictability of Change
...and it Begins Change, defined: The act, process, or result of altering or modifying Change is inevitable and sometimes even predictable but,...
Dec 13 2011,
Final Office Action Rejections for Patent Applications: It Ain’t Over until the Fat Lady Sings…Usually
The patent process can be a long and, at times, tedious process. Many inventors assume that once you file your...
Oct 11 2011,
The CMS/FDA Proposed Parallel Review Process: Can One Clinical Trial Really Satisfy Two Agencies?
Medically necessary vs. safe and effective. Can clinical trials, by design, realistically satisfy the needs of two Federal agencies with...
Oct 11 2011,
The View from Washington: What Device Makers Need to Know about FDA’s Latest Strategic Priorities and Initiatives
Continuously hammered by Congress, news media and the international health community, the U.S. FDA has responded with a five-year plan...
Aug 31 2011,
The Internal Quality Audit Process for Orthopaedic Medical Device Companies: Risk Indicators and Uncertainties
FDA analysis of factory inspections has shown that manufacturers who do not have an adequate quality audit system usually do...
Aug 31 2011,
The Reimbursement Top Ten Checklist: Understanding How Coverage, Codes and Payment Impact the Success of a New Medical Technology
The product design is flawless. The clinical trial endpoints were met. FDA has given the green light to begin marketing....
Jun 30 2011,
Regulatory, Reimbursement & Clinical Challenges in the Orthopaedic Marketplace
The medical device industry faces a number of significant challenges. Federal health care reform, unpredictable U.S. regulatory pathways and an...
Jun 30 2011,
Patent Reform is On the Way…Maybe
For the past several years, Congress has debated several bills that would change the way that patent laws are currently...
Jun 30 2011,
Basic Anatomy of a Design Dossier
This article summarizes key elements required for technical documentation of medical devices provided by manufacturers in order to demonstrate conformity...
Mar 31 2011,
Corrective and Preventive Action: What Does FDA Look For During Inspection?
The orthopaedic industry faces strong pressure from regulatory bodies as well as from the industry to maintain the quality of...
Mar 31 2011,