Module 5_ Writing Assignment (1)
docx
keyboard_arrow_up
School
Arizona State University *
*We aren’t endorsed by this school
Course
561
Subject
Health Science
Date
Dec 6, 2023
Type
docx
Pages
5
Uploaded by KidFlowerYak28
1
A Case Study of PMA Refusal and Strategic
Arizona State University
HCR 552: Medical Device Regulation
Dr.Barbara Fronczkowski
November 16th, 2023
2
In the dynamic field of medical devices, obtaining regulatory approval from the U.S.
Food and Drug Administration (FDA) is a critical step for companies seeking to bring innovative
technologies to market (Center for Devices and Radiological Health, 2021). This essay explores
the scenario where a medical device company, having filed a PreMarket Approval Application
(PMA) with the FDA, receives a "not approvable" letter. The essay delves into the strategic
options available to the company, such as amending the PMA, requesting an administrative
review, or withdrawing the application. Additionally, it examines the reasons behind the FDA's
refusal to file a PMA, emphasizing incomplete applications and the presence of false statements.
Strategic Options to Progress the Device Forward:
The first option to progress is to amend the PMA as requested. The FDA, in its "not
approvable" letter, may have identified deficiencies or information gaps. One strategic option is
to address these concerns by amending the PMA. For instance, if the FDA raised questions about
the adequacy of clinical data, the company can conduct additional well-designed trials to provide
the necessary data. Example: Suppose the medical device company specializing in cardiac
monitoring devices receives feedback from the FDA regarding insufficient clinical data. In
response, the company initiates new clinical trials, including a larger and more diverse patient
population, to address the FDA's concerns comprehensively.
The second option to progress is to request an administrative review. When in
disagreement with the FDA's decision, the company can opt to request an administrative review
by filing a petition for reconsideration. This involves presenting compelling arguments and
additional evidence supporting the device's safety and efficacy. Example: If the FDA's decision is
based on the interpretation of clinical trial results, the company may engage experts to provide
3
additional analyses or opinions challenging the FDA's assessment.
Another option to progress is withdrawing the PMA. In cases where the challenges
identified by the FDA are substantial or align with a strategic shift, voluntarily withdrawing the
PMA is a viable option. This provides the company with an opportunity for a fresh start, whether
pursuing a different regulatory pathway or modifying the device significantly. Example: If the
company decides to pivot its focus to a different market segment or undergoes a major device
redesign, withdrawing the PMA allows for a strategic reset.
Understanding FDA's Refusal to File a PMA:
FDA may refuse to file a PMA if the application lacks essential information or fails to
meet the minimum requirements outlined in section 515(c)(1) (A)-(G) of the FD&C Act. This is
grounded in 21 CFR 814.42, where the FDA has the authority to determine the suitability of a
PMA for filing based on completeness.
Refusal to file can also occur if the PMA contains a false statement of material fact or if
the justification for omitting required information is deemed inadequate. Section 814.45 of 21
CFR outlines the grounds for denial of approval, including instances where the PMA contains
false statements or lacks proper justification.
In conclusion, navigating the FDA's regulatory landscape is a complex endeavor for
medical device companies. In the face of a "not approvable" letter, strategic decision-making
becomes paramount. Whether through amending the PMA, requesting administrative review, or
withdrawing the application, each option requires careful consideration of the device's
characteristics, market potential, and the FDA's specific concerns. Furthermore, understanding
why the FDA may refuse to file a PMA, particularly due to incomplete applications or the
Your preview ends here
Eager to read complete document? Join bartleby learn and gain access to the full version
- Access to all documents
- Unlimited textbook solutions
- 24/7 expert homework help
4
presence of false statements, underscores the importance of diligence and compliance in the
regulatory process. This case study exemplifies the intricate interplay between regulatory
agencies and medical device innovators striving to advance healthcare technologies.
5
References:
Center for Devices and Radiological Health. (2021, September 13).
PMA review process
.
U.S. Food And Drug Administration. https://www.fda.gov/medical-devices/premarket-
approval-pma/pma-review-process