Utilization of Special 510(k) Submissions: Pathway Benefits & Scenario Analysis
1 Hour Video | Janice Hogan, Hogan Lovells
The special 510(k) submission process was introduced in the late 1990’s as part of the FDA’s initiative to provide alternative approaches to the traditional 510(k) clearance route, while simultaneously reducing regulatory burdens and review times. Over time, the scope of special 510(k) use and the FDA’s methodology on reviewing such submissions has shifted, particularly under the FDA’s Refuse to Accept (RTA) policy enacted in 2013. While the FDA hasn’t released any new or updated guidance regarding special 510(k)s, industry regulators are stymied as to what the best approach may be for modified devices which have been previously obtained 510(k) clearance.
- Understanding FDA’s application of requirements
- Trends in use and approval of special 510(k)s
- Requirements for declaring conformance
- Approval time frames
- Rejected submissions
- Defining ideal circumstances for a special 510(k) submission
- Forecasting future develops and impacts on industry
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Legal Counsel
- Compliance Officers
Janice Hogan is the Managing Partner of Hogan Lovells’ Philadelphia office and is Co-Director of our FDA/Medical Device practice. Janice focuses her practice primarily on the representation of medical device, pharmaceutical, and biological product manufacturers before the U.S. Food and Drug Administration (FDA).
Janice is a biomedical engineer and focuses on regulatory counseling related to high technology medical products. Prior to becoming an attorney, she held positions in marketing/marketing research for a major pharmaceutical manufacturer. She has authored articles regarding the medical device 510(k) review process, regulation of medical software, orphan drug regulation and medical device products liability. She is currently authoring articles regarding the use of finite element analysis and other engineering modeling methods in FDA submissions, as well as the interface between FDA regulatory and reimbursement considerations in the design of medical product clinical trials. She has authored a chapter of a recent textbook, Promotion of Biomedical Products (FDLI 2006) and is authoring a chapter of a forthcoming textbook on the regulation of orthopedic implants.