Device Research


Friday, September 24, 2021 at 11:00 am to 11:45 am ET                                         Track: Device Research
Ensuring Clinical Data Quality and Integrity

The FDA recently amended its regulations on the acceptance of data from clinical investigations for medical devices. Under the new rule, the FDA is requiring that data submitted be from investigations conducted in accordance with good clinical practice (GCP). Ms. Fullin will provide an overview of the concepts and practices required to ensure the quality and integrity of clinical data, thus ensuring acceptance of data from device clinical investigations, and ultimately supporting a successful submission. 317

Presenter: Regina Fullin, BS, CQE, CQA, CMQ-OE, Vice President of RA/QA Consulting, Compliance Team, LLC


Friday, September 24, 2021 at 11:50 am to 12:35 pm ET                                         Track: Device Research
Lessons Learned: De Novo Classification Pathway

The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. Ms. Headlee will provide an introduction to the De Novo pathway and identify best practices to optimize the use of the program through a case study discussion. 319

Presenter: Donna Headlee, BSN, RN, CCRP


Friday, September 24, 2021 at 1:40 pm to 2:25 pm ET                              Track: Device Research
ISO 14155:2020 – One Year Experience – An Update

ISO 14155:2020, published in July 2020, brings a major update of the international GCP requirements for medical devices, especially in the fields of risk management and study design. Its implementation along with the implementation of the EU-MDR brings particular challenges. Ms. Giroud will provide feedback on the practical implementation of the standard for medical device studies throughout the world. 323

Presenter: Danielle Giroud, MBA, RN, CEO, MD-Clinicals SA


Friday, September 24, 2021 at 2:30 pm to 3:15 pm ET                            Track: Device Research
Composing and Maintaining Global Clinical Evaluation Reports (CER) Best Practices and Impact of MDR/IVDR

As Europe transitions to the MDR/IVDR and Asia Pacific Regulators (including Australia’s TGA) focus more on clinical evidence, creating a Clinical Evaluation Report (CER) that meets international regulators’ expectations, is becoming increasingly complex. Mr. Jimenez will review MEDDEV 2.7/1 Rev 4 requirements with an emphasis on strategies to meet individual requirements of specific regulators in one document. Key guidance on navigating the world of Clinical Evaluation Report and the MEDDEV 2.7/1 revision 4 guidance will be shared. Mr. Jimenez will also cover areas of focus for manufacturers and sponsors, based on recent feedback from European Notified Bodies and TGA reviews. 325

Presenter: Luis Jimenez, Chem E, MBA, Vice President of Business Development, PharmaLex


Saturday, September 25, 2021 at 11:00 am to 11:45 am ET                                         Track: Device Research
FDA Design Control Requirements for Medical Device Clinical Research

Ms. Nikova will focus on the key procedures and records that must be established and maintained at the sponsor company to control the design of a medical device before a human clinical study can take place as outlined in 21 CFR 812. Ms. Nikova will present an overview of the validation testing that will need to be conducted and presented to an Institutional Review Board (IRB) for first-in-human use of a medical device. This will touch on the importance of preparing these key procedures and records prior to making a submission to  an IRB, which is required of all companies that wish to conduct their clinical trial of a medical device. 427

Presenter: Yulia Nikova, BS, CCRP, RAC, Regulatory Project Manager, Ken Block Consulting


Saturday, September 25, 2021 at 11:50 am to 12:35 pm ET                                        Track: Device Research
Sunshine Act and State Transparency Reporting

Ms. Thompson will provide an overview of Physician Payments Sunshine Act. 429

Presenter: Joanne Thompson, JD, Director of Compliance, Hillrom