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Current Issue: March 2010
Ronald S. Warren, Medical Device Consultants Inc.
A new guide has been published that is recommended reading for every manager in a medical device manufacturing company: How to Avoid and Respond to FDA Criticisms—Form 483 Letters—for Temperature, Humidity and Other Controlled Environments. Read more.
Ames Gross, Pacific Bridge Medical
China's State Food and Drug Administration (SFDA) issued various medical device GMP regulations in December 2009. These regulations include detailed GMP rules for sterile and implantable medical devices and GMP inspection standards for these devices. Read more.
René Clément, MediMark Europe
Medical device manufacturers are required to comply with Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC by 21 March 2010. Despite having made every effort to meet the essential requirements, companies may be surprised to learn that the classification of some of their devices may be challenged. Read more.
David M. MacKenzie, Microsafe Systems and Noblitt & Rueland
Today many medical device companies are at least basically compliant with ISO 14791:2007, "Application of Risk Management to Medical Devices." But is this enough? Read more.
Consultants Corner Archives
- New Year but Questions Remain About Changes at FDA
As we enter 2010, much uncertainty remains about how personnel and policy changes at FDA and CDRH may impact the medical device industry. In 2009, there were a number of shifts at the agency that could transform the regulatory landscape for device and diagnostic manufacturers in the United States.
- Global Perspectives: Asia/Pacific: Cooperation Among Japan, EU, Canada, and US on the Rise
Japan's Ministry of Health, Labor, and Welfare (MHLW), with the Pharmaceuticals and Medical Devices Agency (PMDA), has concluded confidentiality agreements with the European Commission's (EC) Directorate General Enterprise and Industry and Health Canada.
- Global Perspectives: European Union: European Commission Publishes New MEDDEV Guidelines
The end of 2009 turned out to be a very prolific period for the publication of new or updated guidelines.
- Global Perspectives: North America: Why FDA Warning Letters Target Training Deficiencies (and How to Avoid Being on the Receiving End)
Numerous companies in recent years have received FDA warning letters that cite training deficiencies. Why do companies receive warning letters that cite training issues?
- Finding a Qualified Distributor in Europe
With 500 million people in 27 countries, the European Union is a huge market. It is also a challenging one because of language barriers and differences in business culture. Establishing national distributorships is vital to long-term success. Put the odds in your favor by following these five steps when selecting a distribution partner.
- Global Perspectives: Asia/Pacific: Device Manufacturers in China Face Increased Regulatory Scrutiny
China’s State Food and Drug Administration (SFDA) continues to ramp up plans to improve quality and increase regulations in the medical device arena.
- Global Perspectives: European Union: European Union: Please Read Carefully: Label and IFU Revisions Take Effect Next Year, Part II
This is the second of a two-part article on changes to labels and instructions for use (IFU) in Directive 2007/47/EC, which will become law on March 21, 2010. This time we will focus on how devices containing phthalates will be affected.
- Global Perspectives: North America: Documenting Software in a 510(k) Submission Is a Strategic Decision
Computers, software, and medical devices have become much more complex since I first developed medical device software in the 1980s. Equally important, FDA’s premarket review of software in medical devices has become orders-of-magnitude more rigorous since that time. In 510(k) submissions for devices containing software prepared in the 1980s, the description of the software could consist of a single sentence: The device has software. The software information in a typical 510(k) submission today can easily constitute half of the total submission, if not more.
- The Importance of Maintaining Compliance in an Uncertain Economy
In the year since the bottom fell out of the economy, I have seen many clients, large and small, struggle to maintain regulatory compliance. At the same time, FDA’s budget has increased, it is hiring additional resources, has a new commissioner and soon a new director at CDRH, and is promulgating new regulations and guidance documents such as the recent draft guidance, “Presenting Risk Information in Prescription Drugs and Medical Device Promotion.”
- Global Perspectives: Asia/Pacific: Formal Notification Imminent for Medical Device Regulations in India
In June 2009, the Drug Consultative Committee (DCC) and the Drug Technical Advisory Board (DTAB) approved new formal regulations for India’s medical device sector. The new regulations, titled Schedule M-III, have been sent to the Ministry of Health for final notification, which is expected soon.
- Global Perspectives: European Union: Label and IFU Revisions Take Effect Next Year, Part I
In the past two issues of this newsletter, we published a comprehensive glossary of revisions to Medical Device Directive 93/42/EEC and Active Implantables Medical Device Directive 90/385/EEC. Now, we begin another two-part article focusing on changes to labels and instructions for use (IFU) that will become law on March 21, 2010.
- Global Perspectives: North America: FDA 510(k) Reviews Becoming More Rigorous
According to regulation, a new device must demonstrate “substantial equivalence” to receive 510(k) clearance. To establish equivalence, the new device must have the same general intended use as a predicate device. Substantial equivalence determination is also predicated on the technological characteristics of the device. New devices are often designed with patentable differences in technology. These differences can give the edge over the competition, but they can pose challenges in demonstrating “substantial equivalence.” It is the technical differences that give FDA pause, as it must establish whether the new characteristics affect safety or effectiveness.
- A Tale of Two FDA Inspections
The myopic approach of agency inspectors does a disservice to an increasingly sophisticated industry.
- Global Perspectives: Asia/Pacific: Korea Set to Revise Product Approval Process
Korea is an important Asian destination for foreign medical devices. Its total medical device market is about $3 billion. While this may seem low compared with China’s $7.5 billion, Korea’s health expenditure per capita in 2006 was $705 whereas China’s was $61, according to the World Health Organization.
- Global Perspectives: European Union: Device Directive Revisions Become Law in March 2010—Are You Prepared? Part II
In the previous Consultants Corner newsletter, we published the first part of a comprehensive glossary of revisions to Medical Device Directive 93/42/EEC and Active Implantables Medical Device Directive 90/385/EEC. In this issue, we continue our review of the revisions beginning with changes involving the declaration of conformity.
- Global Perspectives: North America: Practical Points to Consider for a Compliant Design Control Process
FDA continues to cite manufacturers for serious design control violations found during inspections that lead to warning letters. Very recently, a company received a warning letter that included significant design control findings. It suggested the company consider withdrawing a previously cleared 510(k) if it is found to have unreliable or unverifiable data. Imagine the impact to your company if you had to remove a major product from the market because a 510(k) had to be withdrawn. We have put together some practical points to consider when implementing and maintaining a compliant design control process.
- Strategies for Conducting Regulatory and Clinical Activities When Money Is Tight
In spite of the economic downturn, opportunities exist to continue product development activities while avoiding significant capital expenditures. There are numerous regulatory and clinical activities that companies may undertake that do not necessarily require large outlays of capital to complete.
- Global Perspectives: Asia/Pacific: "One Test, One Fee" Policy and Adverse Event Reporting Herald More Regulatory Changes to Come in China
The regulatory environment for medical devices in China is changing rapidly. The State Food and Drug Administration (SFDA) is attempting to bring device regulation up to international standards, so there are frequent changes.
- Global Perspectives: European Union: Device Directive Revisions Become Law in March 2010—Are You Prepared?
On 21 March 2010, the revisions to Medical Device Directive 93/42 EEC and Active Implantables Medical Device Directive 90/385/EEC will become law. The most important changes apply to the clinical data and design documentation requirements for all classes of devices.
- Global Perspectives: North America: Using Key Standards Can Help Device Makers to Achieve U.S. and Global Compliance
Let's say you need to develop a product that will be accepted in the United States as well as globally. What standards do you use? Fortunately, the world is harmonizing. So, your team usually will be able to select key standards that will, with some small tweaks, apply globally.
- New Year’s Resolutions that Med-Tech Companies Should Consider
The broad retreat of financial markets in 2008 caused historic declines in just about every sector of U.S. industry.
- Global Perspectives: Regulatory Harmonization Is Coming to Southeast Asia’s Medical Device Market
Currently, if you want to sell your medical device into Southeast Asia--a region with a combined population of nearly 600 million people -- you need to contend with wide regulatory variations.
- Global Perspectives: European Union: Bar Coding for Medical Devices Is Becoming a Regulatory Requirement
For many years, medical device manufacturers primarily used bar codes internally to track products as they moved from manufacturing facilities to labeling sites to distribution centers.
- Global Perspectives: North America: FDA Compliance for Software Validation of Automated Processes
FDA regulation of software validation for automated processes used as part of production or the quality system for medical device manufacturers has been evolving over the last several decades.
- Electronic Data Capture in Clinical Trials: Four Factors for Success
Real-time data access and automated edit checks are just two of the many benefits that EDC can bring to clinical trial management.
- Q&A: FDA and ISO Guidance
Guidance for device makers who voluntarily submit ISO audit reports has been delayed by FDA until the end of this year. Will the agency make its new deadline? We asked Nicolaas C. Besseling, principal, BesTech Consulting Services, about that and some related matters.
- Chapter and Verse on SOPs
Take a commonsense approach: writing overly restrictive SOPs can lead your company into trouble.
- Q&A: Regulatory Reform in Japan: Is It Change We Can Believe In?
Ames Gross, president and founder of Pacific Bridge Medical, has helped more than 200 medical device companies navigate the often-tortuous business and regulatory practices of countries in the Asia/Pacific region. In this Q&A, he offers some insights on Japan’s regulatory approval process.
- How Effective Are Your Purchasing Process Controls?
As supply-chain issues face unprecedented scrutiny, medical device manufacturers would be wise to strengthen their supplier evaluation process. Here's how.
- Q&A: Developments in Materials Technology
Ronald C. Lilly, president and founder of Alltis Corp., discusses leveraging developments in advanced materials and associated processes into medical device design
- Product Recalls: What the New EU Guidance on Vigilance Doesn't Tell You
Practical advice for non-European manufacturers on implementing a recall without running afoul of competent authorities
- Q&A: Software Engineering Strategies
Advice on sourcing a software development partner from Tim DeFrench, president of RND Group Inc.