Dr. Norman F. Estrin
Instructor Dr. Norman F. Estrin
Product Id 600279
Duration 90 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Revamping the 510(k) Clearance Process-Understanding FDA's Proposals

Overview:

The FDA has proposed an overhaul of the 510(k) clearance system In its release of reports from two working groups, the FDA's goals are to increase the predictability and transparency of the 510(k) process and enhance FDA scientific decision-making.

It will also increase the burdens on industry. For example, if finalized, there will be a new subclass of Class 2 products for which clinical studies will be required. You will learn of possible changes in the de novo process that could streamline the clearance process. There will be new definitions of "Substantial Equivalence" and "intended Use" will be redefined and "Indications for Use" eliminated The FDA will likely increase the requirements for the Summary of Safety and Effectiveness and require a summary of all scientific information known or that should be reasonably known to the submitter regarding the safety and/or effectiveness of the device under review. 510(k) submitters would have to provide photographs and design schematics along with detailed device descriptions, which would be available to the public on a revamped 510(k) database. In an attempt to keep up with the rapid pace of innovation in the medical device industry, the FDA plans to issue "Notice to Industry" letters to alert industry to changes in regulatory expectations by FDA for a particular group of devices, plus much more!

Why you should attend: Anyone involved in preparation of 510(k)s or has products with 510(k) clearance should be concerned about the wide-ranging changes proposed by the FDA in the way 510(k)s are reviewed and regulated. While it will take some time for the FDA to finalize its regulations, some changes could be implemented in weeks or months. Therefore, it is prudent to get an overview of the type of changes being considered and the potential impact on your company and products. Comments are being accepted by the FDA now for a limited time.

Areas Covered in the Session:

  • How the de novo classification process may be streamlined to permit lower-risk novel devices to reach the market faster
  • What changes are being considered be made to better train reviewers.
  • How FDA proposes to use outside experts and the web to tap into outside sources of knowledge.
  • Why FDA feels that it needs a class Ilb designation for those class II devices for which clinical and/or manufacturing information would be required
  • How FDA would use a "Notice to industry" to communicate changes in regulatory expectations for groups of devices.
  • How changes in definitions of key terms in the FDA 510(k) review process, such as Intended Use" and "Indications for Use" could impact the process.
  • Understand how FDA's proposed Center Science Council would promote more consistent, science-based reviews.
  • Why FDA wants to vastly expand the Summary of Safety and Effectiveness requirement to require inclusion of all scientific information reasonaly known to the submitter regarding the safety and/or effectiveness of the device that is the subject of the 510(k).
  • How an enhanced FDA database could save industry time and effort in locating information for the 510(k) submission.
  • Why FDA may prohibit use of a particular predicate device
  • When FDA would consider rescinding a 510(k)

Who Will Benefit:
  • Regulatory Affairs Departments in medical device companies
  • Attorneys
  • Regulatory Consultants
  • Management

Speaker Profile
Dr. Norman F. Estrin is Founder and Managing Partner of Estrin Consulting Group LLC. (ECG), which offers consulting to cosmetic, OTC drug and medical device firms on FDA-related regulatory issues. He has had over 35 years of experience in handling scientific and technical and FDA regulatory issues in the medical device, OTC drug and cosmetic industries. He is also experienced as a company expert witness in alleged cosmetic injury cases.

Dr. Estrin conceived and edited books on cosmetic, drug and medical device regulation as well as the International Cosmetic Ingredient Dictionary and helped establish major scientific programs while Senior Vice President-Science of the Cosmetic, Toiletry and Fragrance Association (Now, the Personal care Products Council). He received the cosmetic Industry’s two highest honors, the Maison deNavarre Medal Award and the CIBS Award for "an outstanding career of contributions to cosmetic science and to the cosmetic industry." He has served on many boards, including The National Health Museum (under former U.S. Surgeon-General, C. Everett Koop, M.D.), Chantal Pharmaceuticals Corporation and, currently, Maven Biotech. He holds a doctorate in physical-organic chemistry from Florida State University.

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