In releasing draft guidance on premarket approval applications for medical devices earlier this week, the FDA stated it will accept public comment on the draft until Nov. 14.
According to regulations.gov, the docket number for the relevant document—“Draft Guidance for Industry, Clinical Investigators and Staff; Design Considerations for Pivotal Clinical Investigations for Medical Devices”—is FDA-2011-D-0567.
The proposed guidance outlines agency expectations for clinical trial design issues such as minimizing data bias and variability, setting appropriate study objectives, selecting the appropriate type of study and choosing study sites and study participants.
The FDA’s proposed guidelines for medical device approval, along with its call for public comment on them, come at a time when device manufacturers are at odds with consumer groups over the current approval system. Manufacturers say the current system unnecessarily holds up devices that could save and improve lives. Consumer groups counter that the current system is inadequate for safeguarding patients from dangerous devices and testing how well devices perform in clinical settings.
An FDA webpage on the proposed guidance instructs respondents to submit comments and suggestions to Division of Dockets Management, FDA, 5630 Fishers Lane, Room 1061, (HFA-305) in Rockville, Md., 20852. The agency also is inviting the submission of comments to regulations.gov, and noted that both print and electronic responses must include the docket number.