Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
On February 21, 2018, FDA amended its regulations on the acceptance of data from clinical investigations for medical devices. Under the new rule, FDA is requiring that data submitted from clinical investigations conducted outside of the United States (OUS) intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a humanitarian device exemption (HDE) application, or a product development protocol (PDP) application, be from investigations conducted in accordance with good clinical practice (GCP), which includes review and approval by an independent ethics committee (IEC) and informed consent from subjects. The GCP requirements in the final rule encompass both data quality and integrity and ethical standards for device clinical investigations.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-N-0080.