The U.S. Food & Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is currently undergoing one of its most ambitious reorganizations in decades to initiate the Total Product Life Cycle (TPLC) approach across the organization.
The TPLC methodology, which has been in place in the Office of In-vitro Diagnostics and Radiological Health (OIR) for over a decade, will be implemented within all FDA offices in an effort to create an agile infrastructure that can adapt to future organization, regulatory and scientific needs. Additionally, this new approach is expected to help facilitate information sharing to allow for more informed decisions, ensure process and policy consistency, and provide more straightforward and streamlined interactions with the CDRH.
This restructure will affect many of the offices within CDRH that medical device manufacturers regularly interact with. For example:
- The majority of current divisions across the Office of Device Evaluation (ODE) will now become ‘Offices.’
- Much of the current Office of Surveillance and Biometrics (OSB), and part of the Office of Compliance (OC), will be comprised of a new office: Office of Clinical Evaluation and Analysis (OCEA).
- The Office of In-vitro Diagnostics and Radiological Health (OIDRH), along with the above offices, will comprise of a new ‘Super Office’ termed the Office of Product Evaluation and Quality (OPEQ).
- OPEQ will include a new Office of Regulatory Programs (ORP) which will replace ODE program operations staff and will deal largely with higher level regulatory processes and policy issues.
Below is a simplified listing of offices that fall under the new ‘Super Office:’
Super Office: Office of Product Evaluation and Quality (OPEQ)
I. Office of Regulatory Programs (ORP)
II. Office of Clinical Evaluation and Analysis (OCEA), which consists of parts of:
- Office of Surveillance and Biometrics (OSB); and
- Office of Compliance (OC)
III. Office of Health Technology (OHT) 1-7, which consists of:
- 7 current ODE Divisions comprised of OHT 1-6; and
- Office of In-vitro Diagnostics and Radiological Health (OIR) as OHT 7
Device manufacturers may wonder how this significant reorganization will impact future interactions with the CDRH; the answer is, not as much as one may think – in fact, Sponsors will likely deal with the same individuals that they have in the past. And, this new structure may actually lead to quicker and more consistent reviews and communication with the reviewing offices.
Below, we help explain the CDRH’s restructure in its constituent parts, as well as major players and potential impacts to business operations. (Note: This reorganization is currently in a pilot stage and is expected to officially launch before the end of 2018, dependent on Health and Human Services [HHS] and congressional approval.)
OPEQ, or the new ‘Super Office,’ will be headed by Bill Maisel, the current CDRH Deputy Director for Science. This office will contain 6 (six) device-specific offices:
- Offices of Health Technology (OHT 1-6), comprised of the current 7 (seven) divisions within the Office of Device Evaluation (ODE) with one division split among the others and OIR becoming OHT 7.
- OPEQ will also consist of two new offices, the Office of Clinical Evaluation and Analysis (OCEA), headed by Owen Faris (CDRH’s current Clinical Trials Director) and the Office of Regulatory Programs (ORP), headed by Captain Sean Boyd.
As of this time, the seven OHTs will subsist of the same overall structure, and leadership and review staff. However:
- The Division of Anesthesiology, Respiratory, Infection Control, Anesthesiology, General Hospital, Respiratory, and Dental Devices (DAGRID) will be split between the current Division of Ophthalmic and Ear, Nose, and Throat Devices (responsible for dental, anesthesia, and respiratory devices) and Division of Surgical Devices (overseeing general hospital and infection control devices).
The majority of the current Division Directors will now become Office Directors with most of the current Branch Chiefs becoming Deputy Office Directors.
- The position of Branch Chief will be eliminated under the new organizational structure, however, the points of contact (reviewers) and their immediate supervisors will in most cases be the same as prior to the reorganization.
- OIR, which will become OHT 7, will be folded into OPEQ and will receive a new Office Director, Tim Stenzel, MD, PhD, who comes from industry and has experience most recently with companion diagnostics and next generation sequencing.
The new Office of Clinical Evaluation and Analysis (OCEA) will be made up of:
- Much of the former Office of Surveillance and Biometrics (OSB); and
- Part of the Office of Compliance (OC), notably the Division of Bioresearch Monitoring (BIMO).
Some of the other functions of the OC will be managed by individual OHTs to enhance the TPLC approach. Additionally, the Division of Epidemiology and the Division of Biostatistics will retain much of its current structure but will be located within OCEA. Although branches will no longer exist, most of the current supervisory personnel will remain intact.
The Office of Regulatory Programs (ORP) will consist of 3 Divisions focusing on:
- Submission Support
- Establishment Support (registration and listing, import, exports, audits and FDA inspections)
- Market Intelligence (recalls, shortages, MDR’s, complaints, and lifecycle program analytics)
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 will likely communicate with the same individuals as in the past.
To see a detailed reorganization structure document, courtesy of Advamed, visit: https://www.advamed.org/wp-content/uploads/2021/05/advamed_accel-regulatory_guides-general_overview-final.pdf
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: firstname.lastname@example.org 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.