Elaine Tseng and Laurie Clarke, who are partners in King & Spalding’s FDA & Life Sciences Practice Group, recently participated in panel discussions with Christy Foreman, the Acting Director of FDA’s Office of Device Evaluation (ODE), about changes to the 510(k) program. Elaine spoke at the RAPS annual conference in San Jose on October 26 and Laurie at the IN3/Gray Sheet conference in San Francisco on October 29. We want to share with you the following remarks by Ms. Foreman:

  • Ms. Foreman emphasized that FDA is trying to improve the 510(k) program and not make it harder to obtain clearance. In response to a comment from a venture capitalist that many of the proposed changes would stifle innovation, Ms. Foreman stated that the 510(k) route is not intended for innovative devices.
  • She said that FDA has recently completed its initial review of the 74 comments, which total more than 700 pages, that the Agency received regarding the August 2010 Preliminary Reports and Recommendations of its 510(k) Working Group and Task Force on the Utilization of Science in Regulatory Decision Making, which were due by October 4, 2010. (Please contact us if you would like a copy of the comments we submitted to FDA regarding those reports.) She noted there was substantial support for certain recommendations in those reports, including improving the de novo process, issuing more guidance documents, providing more internal training, and increasing the use of external experts. However, she noted that there was significant opposition to other recommendations, such as enhancing FDA's 510(k) rescission authority, precluding older devices from being used as predicates, establishing a Class IIb, restricting the use of split predicates, combining the concepts of intended use and indications for use, authorizing the Agency to evaluate off-label uses during its review of 510(k) notices, requiring manufacturing information in 510(k) notices, and conducting pre-clearance inspections.
  • Ms. Foreman said that FDA plans to announce its initial proposed changes to the 510(k) process around the middle of this December. She noted that the Agency would provide an opportunity to comment on the proposed changes.  
  • In response to the common criticism that many of the recommendations were vague, she explained that FDA presented general ideas. Depending in part on the internal and external response to them, the Agency will decide whether to develop more detailed proposals.  
  • Ms. Foreman assured the audiences that FDA does not intend to prevent the use of multiple predicate devices or limit the number of predicates that can be used in a 510(k) notice.  
  • She stated that the Federal Food, Drug, and Cosmetic Act prohibits split predicates. She acknowledged, however, that FDA's treatment of split predicates has been inconsistent. She indicated that FDA is considering requiring de novo review of automatic Class III classification ("de novo review") for devices with split predicates once the Agency reduces review times for de novo requests.  
  • Ms. Foreman opined that pre-clearance inspections probably would be rare because of review time limits associated with the Medical Device User Fee and Modernization Act goals.  
  • She concurred with numerous comments that the Agency should not implement all of its proposed changes at the same time.  
  • Ms. Foreman stated that FDA plans to wait until the Institute of Medicine issues its report on the 510(k) program, which is due in March 2011, before implementing, and possibly proposing, major changes. She noted that few of the changes FDA is considering would require Congress to amend the FDC Act despite some comments to the contrary.  
  • Ms. Foreman said FDA plans to issue a revised guidance document for determining whether modifications to a legally marketed device require new 510(k) clearance "soon." In response to our question, she stated that FDA plans to issue it before the end of 2010. She said the "final draft" is currently circulating among the top decision makers in the Agency.  
  • FDA has recently begun posting the Agency's review memoranda for approved 180-day PMA supplements and devices downclassified via de novo review. She noted that as of the end of October, FDA has posted its de novo review memoranda for two devices on its website.  
  • She said that ODE's policy is that reviewers should return phone calls and respond to emails within 48 hours on business days.
  • Ms. Foreman encouraged submitters of 510(k) notices to contact her about problems with the review of specific 510(k) notices. Ms. Foreman emphasized that she cannot fix problems unless she knows about them.