Although the final action dates for the three US Food and Drug Administration (FDA) rules are not set in stone, the agency has said it may finalize new regulations this month, which deal with medical device trial data, postmarket safety reporting requirements for combination products and revised regulations (pending for almost 10 years) on what companies must register establishments and list medical products.
Device Trial Data
The final rule on medical device clinical studies, first proposed in 2013, is intended to update the standards to allow for FDA to accept data from clinical studies conducted outside the US.
“As part of this proposed rule, we are also proposing to amend the IDE [investigational device exemption] and 510(k) regulations to address the requirements for FDA acceptance of data from clinical studies conducted inside the United States. The proposed amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type,” the agency says.
The final rule would rely upon conformance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC), and obtaining and documenting the freely given informed consent of study subjects.
The final rule on postmarket safety reporting for combination products (drug/device, and/or biologic), meanwhile, was set to be released sometime last month and first proposed in 2009.
The rule will clarify the postmarket safety reporting requirements that apply when drugs, devices and biologics are combined to create such a combination product. The rule comes as significant advances have been made in the development of combo products over the past decade and as stakeholders have expressed concern about the lack of concrete information regarding the postmarketing safety reporting regulatory requirements of such products.
The rule establishes various guidelines on what types of alerts and adverse events should be reported, as well as specific examples of different combo products and how information should be sent to FDA.
Facility Reporting Requirements
And finally, after a decade of waiting, drug and biologic manufacturers, importers, repackagers, relabelers and “salvagers of marketed drugs” may see new final regulations this month on how to report to FDA where their facilities are located and what products are being manufactured there.
Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices
Postmarket Safety Reporting for Combination Products
Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs