It’s a constant debate. Pursue a medical device regulatory approval in the US? Or does it make more sense to seek a European approval first? Is there a definitive answer? According to Marc Sanchez, Founder of Contract In-House Counsel, medical device companies would be wise to take a step back and consider the business ramifications first.
In this interview with Marc, we learn more about this hotly debated issue as well as a host of other interesting medical device regulatory trends. Okay, so who is Marc Sanchez? He’s the Founder of Contract In-House Counsel and Consultants. His law practice focuses on building a regulatory strategy for start-ups and small to midsize companies in the medical device field. This strategy includes both pre-market approval and post-market surveillance matters.
The 7 Action Points from Marc Sanchez
These 7 key takeaways will serve as your unofficial cheat sheet:
Choosing Between FDA Approval and a CE Mark is a Strategic Business Decision
While deciding between FDA approval and a CE mark, Marc advises his clients to analyze the situation from a business perspective, rather than a regulatory perspective. Getting a CE mark in no way expedites the FDA approval process. Therefore, if a company decides to go to Europe first, it should be solely because it has an established marketing and distribution network there, along with the capabilities to manage these resources from an entirely different continent. Not because it wishes to speed up the FDA approval process later.
Conducting Thorough Research on your Product and the Applicable Regulatory Procedures is the First Step if you are Seeking Approval
Marc feels that it is imperative for every business manager to identify whether his medical device falls under the exempt category or under Class I, II, III, and thereafter understand the regulatory procedures applicable. For Class I and II devices, one needs to concentrate on finding a predicate device and can then follow the 510(k) procedure. However, for Class III devices, the way forward is almost always a PMA, and will involve a panel review.
Raging Debate Over Innovation vs. Regulatory Process
The recent PIP breast scandal has exposed the loopholes in the European regulatory procedure where a company was selling unapproved breast implants for about 10 years in France before being detected by post-market surveillance. The FDA had banned the implants of this very same company after it inspected the manufacturing conditions in Europe. While the FDA is being hailed for its watchful eye pertaining to the PIP scandal, many argue that the FDA’s tight regulations stifle innovation in the medical device industry. If fact, some consider Europe to be ahead of the US in terms of medical device technology, due to its less stringent regulatory procedures.
FDA Has Been Increasing Focus on Post Market Surveillance
There is an increased focus on safety within the FDA, especially since many medical devices are now imported from China, Europe, etc. Therefore, the FDA is increasing its inspections in these places to determine that the correct manufacturing, labeling practices, etc. are being followed. In case of any discrepancy, the company is issued a Form 483. According to Marc, the fact the FDA has been ramping up its post-market surveillance is evident from the fact that a record ten thousand 483 citations were issued in 2011.
CDRH has Issued New Guidelines in Order to Maintain Continuity Between Reviewers
The PMA timeframe is generally four years due to the number of clinical trials and data needed by the FDA for approval. Due to the high turnover at CDRH, there has been a problem in the continuity of reviewers because of the difference in the standards of approval. However, very recently, the CDRH has issued set guidelines in order to maintain continuity between reviewers, which will hopefully make the review process smoother.
Reading the Fine Print in your Employee Agreement Document is an Absolute Must
The recent case of whistleblowing involving FDA reviewers who reported information to the Congress, but were having their e-mails monitored by the FDA, brings to light the importance of knowing and understanding workplace policies. Most agreements mention that the employee’s computer will be monitored, which implies that private emails are also monitored. Therefore, any information which the employee wishes to keep private must never be accessed from the workplace.
Implementing Social Media Policies at the Workplace is the Need of the Hour
Marc advises all his clients to have strict social media policies in place, which would imply everything the employee does on the work machine, on the work servers, and on the work cell phone…is monitored and not private. However, along with such strict policies, Marc feels that employers should provide their employees with some breathing space, and not take offense at things said on social media sites provided they are done off duty hours and do not include any sensitive company information.
It’s a constant debate. Pursue a medical device regulatory approval in the US? Or does it make more sense to seek a European approval first? Is there a definitive answer? According to Marc Sanchez, Founder of Contract In-House Counsel, medical device companies would be wise to take a step back and consider the business ramifications first.
In this interview with Marc, we learn more about this hotly debated issue as well as a host of other interesting medical device regulatory trends. Okay, so who is Marc Sanchez? He’s the Founder of Contract In-House Counsel and Consultants. His law practice focuses on building a regulatory strategy for start-ups and small to midsize companies in the medical device field. This strategy includes both pre-market approval and post-market surveillance matters.
The 7 Action Points from Marc Sanchez
These 7 key takeaways will serve as your unofficial cheat sheet:
Choosing Between FDA Approval and a CE Mark is a Strategic Business Decision
While deciding between FDA approval and a CE mark, Marc advises his clients to analyze the situation from a business perspective, rather than a regulatory perspective. Getting a CE mark in no way expedites the FDA approval process. Therefore, if a company decides to go to Europe first, it should be solely because it has an established marketing and distribution network there, along with the capabilities to manage these resources from an entirely different continent. Not because it wishes to speed up the FDA approval process later.
Conducting Thorough Research on your Product and the Applicable Regulatory Procedures is the First Step if you are Seeking Approval
Marc feels that it is imperative for every business manager to identify whether his medical device falls under the exempt category or under Class I, II, III, and thereafter understand the regulatory procedures applicable. For Class I and II devices, one needs to concentrate on finding a predicate device and can then follow the 510(k) procedure. However, for Class III devices, the way forward is almost always a PMA, and will involve a panel review.
Raging Debate Over Innovation vs. Regulatory Process
The recent PIP breast scandal has exposed the loopholes in the European regulatory procedure where a company was selling unapproved breast implants for about 10 years in France before being detected by post-market surveillance. The FDA had banned the implants of this very same company after it inspected the manufacturing conditions in Europe. While the FDA is being hailed for its watchful eye pertaining to the PIP scandal, many argue that the FDA’s tight regulations stifle innovation in the medical device industry. If fact, some consider Europe to be ahead of the US in terms of medical device technology, due to its less stringent regulatory procedures.
FDA Has Been Increasing Focus on Post Market Surveillance
There is an increased focus on safety within the FDA, especially since many medical devices are now imported from China, Europe, etc. Therefore, the FDA is increasing its inspections in these places to determine that the correct manufacturing, labeling practices, etc. are being followed. In case of any discrepancy, the company is issued a Form 483. According to Marc, the fact the FDA has been ramping up its post-market surveillance is evident from the fact that a record ten thousand 483 citations were issued in 2011.
CDRH has Issued New Guidelines in Order to Maintain Continuity Between Reviewers
The PMA timeframe is generally four years due to the number of clinical trials and data needed by the FDA for approval. Due to the high turnover at CDRH, there has been a problem in the continuity of reviewers because of the difference in the standards of approval. However, very recently, the CDRH has issued set guidelines in order to maintain continuity between reviewers, which will hopefully make the review process smoother.
Reading the Fine Print in your Employee Agreement Document is an Absolute Must
The recent case of whistleblowing involving FDA reviewers who reported information to the Congress, but were having their e-mails monitored by the FDA, brings to light the importance of knowing and understanding workplace policies. Most agreements mention that the employee’s computer will be monitored, which implies that private emails are also monitored. Therefore, any information which the employee wishes to keep private must never be accessed from the workplace.
Implementing Social Media Policies at the Workplace is the Need of the Hour
Marc advises all his clients to have strict social media policies in place, which would imply everything the employee does on the work machine, on the work servers, and on the work cell phone…is monitored and not private. However, along with such strict policies, Marc feels that employers should provide their employees with some breathing space, and not take offense at things said on social media sites provided they are done off duty hours and do not include any sensitive company information.
