FDA has issued three guidances relating to medical device electronic submissions, PMA acceptance and filing review, and 510(k) Refuse to Accept policy.
The first, eCopy Program for Medical Device Submissions, explains the new eCopy program for medical device submissions mandated by Section 745A(b) of the FD&C Act that was added through the FDA Safety and Innovation Act. The guidance tells how FDA is implementing the provision and says that inclusion of an electronic copy is expected to improve review process efficiency by allowing for the immediate availability of an electronic version for review rather than relying solely on the paper version. The guidance provides, among other things, the standards for a valid eCopy submission under Section 745.
Next, Acceptance and Filing Reviews for Premarket Approval Applications (PMAs), modifies the PMA filing guidance and checklist, separating the criteria for PMA filing into acceptance criteria and filing criteria. The guidance says that since FDA agreed to MDUFA performance goals based on review timeliness, acceptance review takes on additional importance in both encouraging quality applications from PMA applicants and allowing the agency to appropriately concentrate resources on complete applications.
Finally, Refuse to Accept Policy for 510(k)s explains the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review. The guidance says that with the MDUFA performance goals based on review timeliness, acceptance review takes on increased importance. FDA says it has modified the 510(k) Refuse to Accept policy to include an early review against specific acceptance criteria and to inform the submitted within the first 15 calendar days after receipt of the submission if it is administratively complete.
In addition CDRH plans to unveil an outline for standardized medical device product labeling at an April 29 public workshop exploring drug-like labeling formats for devices. “The purpose of this public workshop is to discuss the growing need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers may access and utilize device labeling as efficiently and effectively as possible,” an agency notice says.
FDA says it is concerned that the lack of standard content and format may translate into increased medical device errors. “Also, there is no single available labeling source for people to view, search, and download for devices that are used in clinical and non-clinical environments,” the notice says.
Key findings from a recent research survey helped create the new outline for standard content and format for medical device labeling that identifies the most relevant sections, the agency says. The survey also called for a condensed labeling version to act as a quick reference for safe and effective device use, which will also be discussed at the workshop.
—Jim Dickinson is a long-time contributing editor to MD+DI.