If interested, here's an article that was recently posted on SPS about this very subject: New Study: FDA Impact on Innovation.

Shuren's Innovation Fix

Orthopedics This Week
Walter Eisner • Mon, Jan 31st, 2011
Copyright 2009 - 2011 RRY Publications

Jeff Shuren, M.D., J.D., the FDA’s top medical device regulator, the agency itself and the President of the United States want to close a "device gap" with the EU, keep (or return, depending on your point of view) the U.S. in the lead for developing and promoting new medical technologies.

Jeff Shuren, M.D., J.D.To close the gap, Shuren, on January 19 unveiled 25 changes to streamline and improve the 510(k) clearance process.

According to a statement from the FDA, the changes include:
  • Streamlining the “de novo” review process for certain innovative, lower-risk medical devices,
  • Clarifying when clinical data should be submitted in a premarket submission, guidance and thereby increase the efficiency and transparency of the review process,
  • Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making.
Shuren told crowds at town hall meetings throughout the summer of 2010 that the agency has two missions: “protect and promote” public health. We know from studies that 99.8% of the devices cleared via the 510(k) process have not had reported device-specific adverse events. So, the “protect” mission has apparently been well met. Therefore, after 35 years of the existing 510(k) program, the time has come to improve the “promote” mission.

The FDA's announcement was previewed by President Barack Obama in a Wall Street Journal opinion article the day before specific changes were announced. The President wrote the changes would result in "getting innovative and life-saving products to market faster."

Better, Faster and Less Confusion

Shuren told OTW during his press conference that the changes to the 510(k) program will "increase predictability" and "reduce uncertainty" for device developers. Such changes, said Shuren, should make the collection of data by manufacturers more efficient as FDA scientists ask more and better targeted questions. In addition, through the newly established Center Science Council, headed by Bill Maisel, M.D., M.P.H., more senior scientists will be able to rule more quickly on science questions and, Shuren hopes, will speed up the review process. In effect, Shuren promises that the FDA will get better, faster and less confusing, saving device developers time and money.

In addition, among the 25 changes to be implemented throughout 2011 and outlined below, the agency will streamline the “de novo" process to allow new devices without predicates, but deemed safe, to avoid the costly and lengthy PMA "approval" process and be allowed to enter a new and better 510(k) process.

From his lips to God's ears.

The day before the changes were announced, we understand that the FDA informed ReGen Biologics that the company will not be allowed to enter the de novo process. Let’s hope ReGen is not an example of a new and improved de novo process. The company’s device was deemed safe by two separate FDA orthopedic panels.

Industry Pleased, Cautiously

Will these changes make it faster and less expensive to get new devices to patients? Will this close the device gap?

Overall, industry representatives seemed pleased with the changes. Bill Hawkins, CEO of Medtronic, reportedly said that the company was "encouraged" by the FDA's release on the actions to implement in 2011.

AdvaMed, the nation's largest medical device trade association thinks this is a move in the right direction.

The association’s Senior Vice President David Nexon reportedly said during a call with reporters that the modifications "generally adhere to our principal that changes should be targeted, have a corresponding health benefit and support timely access treatments and cures."

Nexon warned that the changes are only the first part of what he called a "very complicated set of implementation steps.".

The Rollout

The FDA intends to roll the plan out through a process of guidance documents and proposals for new rules, both of which will be open for public comment while in development. See the timeline below.

Nexon told reporters that there will be at least eight guidance documents that the agency needs to put out over the coming year and how those come out "will make a big difference in whether the FDA continues to move in the right direction."

Many of the changes have the potential to improve the timeliness and consistency of the review process. For example, the FDA is proposing to enhance reviewer training, involve external scientific experts, improve the consistency of reviews by developing device-specific guidance documents and streamline the de novo process for medical devices without a predicate, said Nexon.

Mark Leahy, head of the Medical Device Manufacturers Association told us that his group remains concerned that FDA has deferred final decisions on key issues to the Institute of Medicine.

Industry Concession or Promoting Health?

Some "consumer" groups accused Shuren of caving in to industry interests. Diana Zuckerman, Ph.D., of the National Research Center for Women and Families said the FDA's plan suggests "industry lobbyists won, and the public lost."

"Today's FDA report gives the impression that FDA backed down on several safeguards as a result of unfavorable comments," Zuckerman said in a statement.

"FDA decisions should not be based on a popularity contest, especially since lobbyists rig the results."
Even America's “business newspaper,” The Wall Street Journal got in on the act with the headline, "FDA Makes Concessions To Industry In Device Rules." Only a tortious argument could describe steps to promote public health as a “concession” to industry.

When confronted with this accusation, Shuren told reporters, “We don’t use the public as guinea pigs in the U.S.”

More to Come

Nearly half of the 55 changes the agency recommended in August 2010 were temporarily taken off the table, including the most controversial such as the ability to revoke 510(k) clearances, increased post-market surveillance and the establishment of a new classification for medical devices that would require the submission of clinical evidence.

Those changes will be decided following the release of the independent Institute of Medicine review scheduled to be released this summer.

Following is a timeline of the specific changes announced by the agency:

March:
  • Post Council Charter to FDA website to: oversee development of business process and SOP; promote the development of improved quality metrics; periodically audit 510(k) review decisions; establish internal team of clinical trail experts to support and advice on clinical trail design.
  • Pilot program to explore the use of "assurance case" framework for 510(k) submissions.

April:
  • Hold public meeting on making device photographs available in public database without disclosing proprietary information.
  • Hold public meeting on the development of an online labeling repository.

June:
  • Draft guidance to clarify which changes do or do not warrant submission of a new 510(k) and which modifications are eligible for a Special 510(k).
  • Post initial results of 510(k) audit to FDA website.
  • Determine system requirements and select the new platform for a new adverse event database.
  • Post SOP (standard operating procedures) to clarify and quickly inform stakeholders when CDRH (Center for Devices and Radiological Health) has changed regulatory expectations on the bases of new scientific information.
  • Complete program assessment on the root causes of existing challenges and trends in IDE (Investigational Device Exemption) decision making.
  • Issue proposed regulation to permit rapid and accurate identification of devices and improve adverse event reporting and identification of device-specific problems.

July:
  • Draft guidance to improve the equality and performance of clinical guidance.
  • Formalize the Centers internal process for identifying staffing needs and enhance recruitment, retention and training.
  • Post SOPs clarifying the guidance and regulation development process.

August:
  • Develop and implement training on core competencies, including: determination of "intended use"; determining whether 510(k) raises "different questions of safety and effectiveness"; review 510(k)s that use "multiple predicates"; develop and assign product codes; interpret "least burdensome" principles; appropriate use of consensus standards.

September:
  • Draft guidance to streamline the de novo classification process.
  • Draft guidance to provide greater clarity regarding when clinical data should be submitted in support of 510(k); submission of photographs or schematics for internal FDA use; appropriate use of multiple predicates; the criteria for identifying "different questions of safety and effectiveness" and technological changes; resolving discrepancies between 510(k) flowchart and the Food, Drug and Cosmetic Act; the characteristics that should be included in "intended use"; the development of 510(k) summaries to assure accuracy.
  • Develop a network of external experts to leverage external scientific expertise and assess best practices and develop SOPs for staff engagement with external experts.
  • Complete evaluation of methods used to integrate device information into a format so it can be used by staff to make regulatory decisions.
  • Post SOP of a process for regularly evaluating the list of device types eligible for third-party review and enhance the third-party reviewer training.

October:
  • Draft guidance to clarify the appropriate use of census standards.
  • Draft guidance to clarify the process for appealing CDRH decisions.
  • Completed analysis and make results public on the apparent association between citing more than five predicates and a greater mean rate of adverse event reports.

November:
  • Draft guidance to supplement available guidance on pre-IDE meetings and enhance the equality of pre-submission interactions between industry and Center staff.

December:
  • Draft guidance to more consistently develop and assign unique product codes.
  • Issue proposed regulation on better documentation of 510(k) transfers of ownership.
  • Issue proposed regulation on clarifying the statutory listing requirements for the submission of labeling.

All the FDA documents related to these changes can be accessed at:

CDRH Plan of Action for 510(k) and Science