In the fall of 2018, the U.S. Food & Drug Administration’s (FDA) Center for Medical Devices and Radiological Health (CDRH) announced the largest reorganization in years to initiate the Total Product Life Cycle (TPLC) approach across the institution (read more here).
Fast forward to May 1, 2019—the date that the CDRH declared that it had fully implemented the new TPLC organizational structure to create an agile infrastructure that allows for better adaption to future organizational, regulatory and scientific needs.
One of the most noteworthy changes surrounds the Office of Product Evaluation and Quality (OPEQ). This office, directed by Bill Maisel, includes:
- All former divisions of the Office of Device Evaluation (ODE) labeled Office of Health Technology (OHT) 1-6
- The Office of In-vitro Diagnostic and Radiology (OIR)—now labeled the Office of Health Technology (OHT) 7
- The Office of Regulatory Programs (ORP), which will provide submission and establishment support
- The Guidance and Policy staff is now located in OPEQ’s immediate office
Additionally, OPEQ now includes the Office of Clinical Evaluation and Analysis (OCEA), directed by Owen Faris, and is comprised of:
- Biostatistics
- Epidemiology
- Bioresearch Monitoring
- IDE Staff
Though most of the OHTs will have the same leadership and reviewers from the previous ODE Divisions, compliance officers will be embedded within each OHT. Also, the designations of the Offices will be different. For example, the former Division of Cardiovascular devices now falls under the OHT 2.
The new Divisions within each of the new OHTs have been given letter designations (A, B, C, etc.). As such, the new division that oversees Circulatory Support, Structural and Vascular Prostheses is termed DHT 2B, or Division of Health Technology 2B.
A few other important notes:
- Respiratory, Anesthesia, and Dental devices have been folded into OHT 1, with Ophthalmic and ENT devices falling under Malvina Eydelman, the former Director of the Division of Ophthalmic and ENT devices (DOED).
- Opthalamic and ENT devices will be in DHT 1A
- Dental devices will now be managed by DHT 1B and ENT
- Anesthesia and Respiratory devices will fall under DHT 1C
Though there are additional changes observed in the organizational chart, those discussed above will likely be of most importance to U.S. medical device and diagnostic manufacturers. Although many of the senior staff within these new offices will remain the same, they will now have new titles.
Additionally, as noted above, the majority of reviewers will remain consistent, however, it should be emphasized that the CDRH has hired a number of new reviewers who will take time to get up to speed. In conclusion, though the structure has changed, many of the faces at FDA Pre-Submission and Submission meetings will likely remain the same.
What Does this Mean for U.S. Medical Device Manufacturers?
As stated above, this reorganization should have minimal impact on medical device organizations and their interactions with the CDRH. In fact, it is expected that device manufacturers, in many cases, will likely communicate with the same individuals as in the past.
To see the reorganization structure and its leadership in more detail go to https://www.fda.gov/about-fda/cdrh-offices/cdrh-management-directory-organization.
How can NAMSA Help?
Navigating the U.S. FDA regulatory landscape can be overwhelming for any medical device manufacturer – not to mention very cost-intensive. That’s why having the right partner, at the right time, can be invaluable in achieving reimbursement requirements, market success and accelerated timelines.
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the FDA. In fact, our internal teams of medical device development experts communicate with the FDA nearly every day. From Pre-Submission meetings – to Pre-IDE preparation – and FDA inspection preparation, our teams are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers. This expertise has been proven to save medical device organizations up to $17M in costs and 23 months in development timelines (read our most recent case study here).
If you are interested in speaking with us about FDA-related activities or other global regulatory strategies, please contact us at: communications@namsa.com or 1-419-666-9455. You may also visit our regulatory consulting webpage here.
Richard Kotz, Senior Product Development Strategist
Richard Kotz currently works as a Senior Product Development Strategist at NAMSA, the world’s only Medical Research Organization (MRO). He retired from the U.S. Food and Drug Administration (FDA) in 2015 after 25 years as a statistical reviewer and manager in the Center for Devices and Radiological Health, Division of Biostatistics. He led a team of statisticians that reviewed hundreds of clinical trial protocols for Ob-Gyn, urology, gastroenterology, respiratory, diabetes, renal, oncology, anesthesiology, infection control and general surgery devices. He had leadership roles in several statistical organizations, including serving as president of the FDA Statistical Association and chair of the Medical Device and Diagnostic Section of the American Statistical Association. He was awarded the FDA's prestigious Lifetime Achievement Award in 2016.