In the News
A Closer Look: Understanding Risk Management for Medical Device Manufacturers
Completing risk management to ISO 14971 is nothing new for medical device manufacturers. Read more...
Draft Guidance for Pharma & Medical Device Makers Use of Social Media
The Food and Drug Administration recently published draft guidelines for pharmaceutical and medical device companies on the use of emerging electronic media. Read more...
FDA Launches Its Newest Blog--FDA Voice
On December 23, FDA launched its newest official blog called FDA Voice. Read more...
FDA announces 2012 medical device priorities
The FDAs Center for Devices & Radiological Health announces its strategic priorities for 2012. Read more...
Medical Devices to Watch in 2012
The year 2012 might see the much-hyped therapies of stem cells and gene therapy become clinical realities. Read more...
Proposed boost to FDA's budget could turn the heat down on user fee negotiations
FDA negotiations with the medical device industry over user fees may get a little relief if a bill granting the watchdog agency a boost to its 2012 budget gets the green light from Congress. Read more...
ICH Q11 Nears Final Approval After Comments Prompt Changes
The final version of ICH’s drug substance development and manufacturing guideline Q11 is nearing Step 4 clearance by the regulatory agencies. Read more...
FDA Seeks Input on Device Classification System
Recently, the Food and Drug Administration (FDA) opened up a public comment period, extending to mid-January, to get perspective on whether the information gathered during reclassification submissions of medical devices is necessary and useful. Read more...
Five tips on steering medical devices through the FDA
Millions of people use a 510(k) cleared medical device daily without even realizing the product has been evaluated by the Food and Drug Administration. Read more...
Global Harmonization Task Force issues device classification guidance
As it transforms into a new organization, the Global Harmonization Task Force (GHTF) continues to issue guidances likely to influence major medical device regulators worldwide. Read more...
FDA Points to Increased Drug Approvals
Making a case for the nations current drug approval system, federal officials have announced that a relatively high 35 new medicines were cleared by regulators in the recently completed federal fiscal year. Read more...
FDA Seeking Comment on Device Recall Data Collection Policy
The FDAs device recall process, authorized by US federal law, consists of three steps. Read more...
State of Medtech 2011 and Beyond: A SWOT Analysis
An interesting look at the medtech industry for 2011 and beyond, objectively identifying the key strengths, weaknesses, opportunities, and threats it faces. Read more...
Change Filing Requirements Present Continuous Improvement Roadblocks
The power of the advancing pharmaceutical quality systems to manage change and drive continuous improvement is being hampered by the disharmony and inflexibility of the CMC filing requirements across the globe, prominent industry and regulatory experts reemphasized at a quality systems/ICH Q10 conference. Read more...
Pharma Purchasing and Outsourcing Approach Needs Overhauling, Supply Chain Expert Asserts
Regulatory pressure and “true cost” understanding will push pharmaceutical firms to reverse the current outsourcing trend and gain back more control of their critical ingredients and components. Read more...
FDA forms expert panel to speed up device approval
The U.S. health regulator said it is seeking public input on a plan to create a network of outside experts who would help understand new technology in medical devices. Read more...
FDA Process, Taxes Spurring Exodus of Medical Device Firms
Clinical trials shift to Europe, where review process is quicker. Read more...
Report: More than 75% of med-tech companies go overseas first
More than three-quarters of medical device makers go overseas first when launching new products, according to researchers at Northwestern University. Read more...
Draft Guidance from FDA to Improve Design of High-Quality Clinical Studies
Seeking to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices, the FDA has issued a draft guidance. The agency welcomes comments for the next 90 days. Read more...
FDA Announces Training Program to Improve Medical Device Reviews
The U.S. Food and Drug Administration (FDA) just announced two training programs it will be implementing that are intended to improve how medical device reviews are conducted. Read more...
FDA draft document offers guidelines, and raises questions
The questions and comments are pouring in over the U.S. Food and Drug Administration’s draft guidance on mobile medical apps. Read more...
Creating a New Regulatory Framework for Moderate-Risk Devices
The recently released Institute of Medicine (IOM) report Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years recommends that the Food and Drug Administration (FDA) begin to develop a new regulatory framework for moderate-risk (class II) medical devices. Read more...
Study of Medical Device Recalls by FDA Over Last Four Years (2008-2011)
Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. Read more...
ISO publishes Six Sigma performance-improvement methodology
Six Sigma, a data-driven method for improving business and quality performance, has been published as a two-part ISO standard. Read more...
Medical Device User Fee Rates for Fiscal Year 2012
The Food and Drug Administration (FDA) recently announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2012. Read more...
Life sciences venture funding perks up, national report says
Here's some good news in the wake of dire economic reports and wild sways in the stock market: U.S. venture capital investment in the life sciences surged recently. Read more...
FDA Proposes Guidelines That Clarify Benefit-Risk Determinations for Medical Devices
For the first time, the U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices. Read more...
Generic Drug Makers to Pay User Fees
The FDA recently announced an important user-fee deal with generic drugmakers. Read more...
Medical-device users worry they could face cyber-attack
Hundreds of cyber-security geeks watched recently as Jay Radcliffe stood on a Las Vegas stage and hacked into his own insulin pump, disabling its life-saving therapy. Read more...
USP, FDA update quality standards for common drugs
The U.S. Pharmacopeial Convention is working with the FDA and the Consumer Healthcare Products Association to update the quality standards for common medicines. Read more...
FDA Strengthens Global Supplier Oversight
FDA Commissioner Hamburg has created a new FDA enforcement directorate, the Office of Global Regulatory Operations and Policy, under Deb Autor. Read more...
FDA outlines oversight of mobile medical applications
The agency announced it is seeking input on its proposed oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications ("apps") that are designed for use on smartphones and other mobile computing devices. Read more...
FDA: 510(k) times increasing because of poor submissions?
The agency released internal analysis of increasing decision times, confirming industry's claims that the total times for clearance through the 510(k) process have spiked dramatically in the last five years. Read more...
FDA to propose unique ID rule by September
A proposed FDA rule requiring a unique identification system for medical devices is scheduled for release this September Read more...
New FDA Strategy Aims for Safety of Imports
The U.S. Food and Drug Administration (FDA) last month unveiled a new strategy to enlist the participation of international regulators and other “nontraditional partners” to help deal with the rising tide of internationally sourced products. Read more...
The case for Lean Six Sigma in pharmaceutical formulation and process development
The evolution of the pharmaceutical industry has made product formulation, process development, and life cycle management more critical than ever. Read more...
First Stop, Third World: Emerging Markets For Med Tech
For several years now, device companies are going outside of the US to study and initially commercialize their products. Read more...
U.S. Medical Devices Spending Steady, Report Says
Medical devices accounted for about 6 percent of the total U.S. health spending in 2009, barely changed from 10 years earlier and slightly higher than two decades ago. Read more...
FDA's new guidance tackles device usability, safety
Intended to improve the usability of medical devices, as well as reduce errors, injuries and product recalls, the FDA issued a draft guidance June 22 for conducting tests to see how humans interact with technology. Read more...
Medical Device Companies Slow to Adopt Social Media Amid Lack of FDA Guidance
The medical device industry is rife with the exploration and development of new ideas and treatments for a startling array of health conditions. Read more...
ISO 9001 Proven to Help Win New Business
According to data from The British Assessment Bureaus (BAB) independent 2011 Client Satisfaction Survey, 44 percent of respondents said that they had won business as a result of becoming certified to ISO 9001 Read more...
FDA releases results of initial audit of 510(k) program
The FDAs inital review of rejected applications deemed Not Substantially Equivalent found that nearly 80 percent of the rejections cited insufficient performance data, sometimes despite repeated FDA requests. Read more...
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