Volume : 12, Issue : 10, October – 2025
Title:
THE COMMERCIAL ASPECTS OF REGULATORY APPROVALS
Authors :
KYATHAM DEVIKA*, DR. V. SWAPNA, DR. D. VARUN.
Abstract :
Objective To investigate the regulatory approval of new medical devices.
Design Cross sectional study of new medical devices reported in the biomedical literature.
Data sources PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval.
Eligibility criteria for study selection Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.”
Main outcome measures Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device.
Results 5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be “substantially equivalent” to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published.
Conclusions We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study.
Cite This Article:
Please cite this article in press KYATHAM DEVIKA et al., Regulatory Issues For Import Of Pharmaceutical Products Into India , Indo Am. J. P. Sci, 2025; 12(10).
REFERENCES:
1. United States Food and Drug Administration, Center for Drug Evalu- ation and Research, and Center for Biologics Evaluation and Research. Guidance for Industry. Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products. https://www.fda.gov/down- loads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM072008.pdf. Accessed July 9, 2019.
2. United States Food and Drug Administration. Kefauver‐Harris Amendments Revolutionized Drug Development. https://www.fda. gov/ForConsumers/ConsumerUpdates/ucm322856.htm. Accessed July 9, 2019.
3. Ho PM, Peterson PN, Masoudi FA. Evaluating the evidence. Circula- tion. 2008;118(16):1675‐1684.
4. Mahajan R. Real world data: additional source for making clinical deci- sions. Int J Appl Basic Med Res. 2015;5:82‐82.
5. Booth CM, Tannock IF. Randomised controlled trials and population‐ based observational research: partners in the evolution of medical evidence. British journal of cancer. 2014;110(3):551‐555.
6. United States Food and Drug Administration. Real World Evidence. https://www.fda.gov/ScienceResearch/SpecialTopics/ RealWorldEvidence/default.htm. Accessed July 9, 2019.
7. European Medicines Agency. Update on Real World Evidence Data Collection. https://ec.europa.eu/health/sites/health/files/files/com- mittee/stamp/2016‐03_stamp4/4_real_world_evidence_ema_presen- tation.pdf. Accessed July 9, 2019.
8. United States Food and Drug Administration. Framework for the FDA’s Real World Evidence Program. https://www.fda.gov/media/ 120060/download. Accessed July 9, 2019.
9. Swift B, Jain L, White C, et al. Innovation at the intersection of clinical trials and real‐world data science to advance patient care. Clin Transl Sci. 2018;11(5):450‐460.
10. Kondo T. “Rational Medicine” Initiative. https://www.pmda.go.jp/ files/000216304.pdf. Accessed July 9, 2019.
11. Maissenhaelter BE, Woolmore AL, Schlag PM. Real‐world evidence research based on big data: motivation‐challenges‐success factors. Onkologe (Berl). 2018;24:91‐98.
12. Visvanathan K, Levit LA, Raghavan D, et al. Untapped potential of observational research to inform clinical decision making: American Society of Clinical Oncology Research Statement. Journal of Clinical Oncology. 2017;35(16):1845‐1854.
13. Corrigan‐Curay J. Real world evidence a path forward. presented at Duke‐Margolis Center for Health Policy: a framework for regulatory use of real world evidence—September 13, 2017. https:// healthpolicy.duke.edu/sites/default/files/atoms/files/rwe_fda_slide_ deck_2017_09_13.pdf. Accessed July 9, 2019.
14. Endpoints. FDA’s Janet Woodcock: the clinical trials system is ‘bro- ken’. https://endpts.com/fdas‐janet‐woodcock‐the‐clinical‐trials‐ system‐is‐broken/. Accessed July 9, 2019.
15. Merck. European Commission Approves Bavencio (avelumab) for Metastatic Merkel Cell Carcinoma. https://www.merckgroup. com/en/news/bavencio‐ec‐approval‐2017‐09‐20.html. Accessed July 9, 2019.