5.4 Regulatory Strategy - Updates

Update: 2/15/11

New Regulatory Videos Available on eBiodesign
The Stanford University Biodesign team has developed a series of video briefs that address important information about medtech regulatory processes and requirements in the U.S. The videos, which were funded by the Kauffman Foundation, feature regulatory experts Su-Mien Chong and Howard Holstein. They are intended to reinforce and expand upon the regulatory content covered in the Biodesign text. The videos present content on regulatory basics, fundamental regulatory strategies, and several short case studies on medtech companies and their interactions with the FDA.

 Update: 9/21/10

Two new FDA web resources now available
As part of its efforts to improve transparency at the FDA, the agency launched two new web-based resources. The first is a site called FDA Basics (www.fda.gov/fdabasics), which seeks to provide information about how the agency performs its works.  The second is a program performance tracking site called FDA-TRACK (www.fda.gov/fdatrack) where the agency posts metrics regarding the workload and results of more than 100 FDA offices.  More information about the sites and the FDA’s transparency initiative can be found in a New England Journal of Medicine article  by Afia K. Asamoah and Joshua M. Sharfstein (see http://www.nejm.org/doi/pdf/10.1056/NEJMp1005202).

Update: 8/4/10

CDRH Releases Preliminary Recommendations Regarding Changes to Medical Device Regulation
On August 4, 2010, the Center for Devices and Radiological Health (CDRH) released a series of recommendations developed to support three key objectives: “fostering medical device innovation, enhancing regulatory predictability, and improving patient safety.”  The recommendations stem from two inter-related reports issued by the 510(k) Working Group and the Task Force on Utilization of Science in Regulatory Decision Making, which were established in September 2009.  The full reports from these working groups can be found online.

In a foreword (pdf) to the reports, CDRH Director Jeffrey Shuren highlighted 10 specific recommendations.  Among the most important were the following:

  • Streamlining and clarifying the de novo review process for lower-risk devices that are automatically classified at Class III because no suitable predicates exist.
  • Defining guidelines for a subset of moderate-risk Class II devices, called Class IIb, for which clinical or manufacturing data typically would be required to support a substantial equivalence determination.
  • Revising regulations to explicitly require all 510(k) applicants to provide a summary of all scientific information known (or that should be reasonably known) regarding the safety and effectiveness of a new device.

FDA is now collecting public input on the recommendations, which can be submitted online ( through October 4, 2010 -- reference Docket No. FDA-2010-N-0348).
Shuren also announced that the CDRH has established a Council on Medical Device Innovation, which is chartered with identifying unmet public health needs and facilitating the design (or redesign) of devices to address them.  Furthermore, he said, the FDA signed a memo of understanding with the Centers for Medicare and Medicaid Services (CMS) to share information and coordinate efforts to streamline the process of bringing safe and effective new medical technologies to patients.

Errata 12/09/09

Correction in Getting Started Step 1
Under step 1 in the Getting Started section for chapter 5.4, we mistakenly refer readers to section 510(g) of the Food, Drug and Cosmetic Act for more information about requesting device classification information from the FDA.  Requests for designations (or RFDs as they are known within the agency) are actually authorized under section 513(g) of the Act.  Guidance about when and how to submit an RFD can be found in CFR Title 21, Section 3.7. A useful document called “How to Write a Request for Designation (RFD)” is also available on the FDA website.

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