References

US Food & Drug Administration. Classification of products as drugs and devices and additional product classification issues: guidance for industry and FDA staff. 2017. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/classification-products-drugs-and-devices-and-additional-product-classification-issues (accessed 22 December 2020)

US Food & Drug Administration. Combination product definition combination product types. 2018. https://www.fda.gov/combination-products/about-combination-products/combination-product-definition-combination-product-types (accessed 22 December 2020)

US Food & Drug Administration. Combination products guidance documents. 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/combination-products-guidance-documents (accessed 22 December 2020)

US Food & Drug Administration. Medical device exemptions 510(k) and GMP requirements. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm (accessed 22 December 2020)

US Food & Drug Administration. The 510(k) program: evaluating substantial equivalence in premarket notifications [510(k)]: guidance for industry and Food and Drug Administration staff. 2014. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k (accessed 22 December 2020)

US Food & Drug Administration. Format for traditional and abbreviated 510(k)s: guidance for industry and FDA staff. 2019. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-abbreviated-510ks (accessed 22 December 2020)

US Food & Drug Administration. Premarket approval (PMA). 2019. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm (accessed 22 December 2020)

US Food & Drug Administration. Medical device classification product codes: guidance for Food and Drug Administration staff. 2013. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-classification-product-codes-guidance-industry-and-food-and-drug-administration-staff (accessed 22 December 2020)

US Food & Drug Administration. De Novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff. 2017. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/de-novo-classification-process-evaluation-automaticclass-iii-designation (accessed 22 December 2020)

US Food & Drug Administration. Design considerations for pivotal clinical investigations for medical devices: guidance for industry, clinical investigators, institutional review boards and Food and Drug Administration staff. 2013. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-pivotal-clinical-investigations-medical-devices (accessed 22 December 2020)

US Food & Drug Administration. Requests for feedback and meetings for medical device submissions: the Q-Submission program: guidance for industry and Food and Drug Administration staff. 2019. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program (accessed 22 December 2020)

US Food & Drug Administration. Breakthrough devices program: guidance for industry and Food and Drug Administration staff. 2018. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program (accessed 22 December 2020)

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US Food & Drug Administration. Use of real-world evidence to support regulatory decisionmaking for medical devices: guidance for industry and Food and Drug Administration staff. 2017. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices (accessed 22 December 2020)

Hard-to-heal wounds
Wound dressings

Innovation in wound care products: a FDA regulatory perspective

02 February 2021
Editorial
02 February 2021
Volume 5 · Issue 1

The US Food and Drug Administration (FDA) recognises the importance of bringing high-quality, innovative wound care products to the market. This editorial focuses on how the Center for Devices and Radiological Health (CDRH) reviews and supports the development of new devices for wound care. Note that the FDA may regulate a wound care product as a drug, device, biological product or combination product.1 Generally, drugs are reviewed in the Center for Drug Evaluation and Research (CDER), devices are reviewed in the Center for Devices and Radiological Health (CDRH) and biological products are reviewed in the Center for Biologics Evaluation and Research (CBER). A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, a device and a biological product.2,3 If the classification of a product as a drug, device, biological product or combination product is unclear or in dispute, the Office of Combination Products (OCP) assigns the lead agency centre for the product's premarket review and regulation.1

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