In June 2013, the US Food and Drug Administration (FDA) indicated that it was interested in making it easier to submit so-called "806 reports"-filings made to report the removal or correction of a medical device from the market for reasons related to human safety. Now the agency is moving forward with that proposal, submitting it this week for final government review.
Under 21 CFR 806.10, companies are required to make written "reports of corrections and removals" to the US Food and Drug Administration if one (or both) of two conditions are met:
- if a recall or withdrawal is made to reduce a risk to human health presented by a medical device
- if the company has initiated the recall to "remedy a violation" of the Federal Food, Drug and Cosmetic Act which may present a risk to human health
Information about the recall or removal must be sent to FDA within 10 days of initiating the action, and the report must include 15 data points, including:
- the seven-digit registration number of the entity responsible for submission of the report of corrective or removal action (if applicable)
- the month, day, and year that the report is made
- a sequence number (i.e., 001 for the first report, 002 for the second report, 003 etc.), and the report type designation "C" or "R"
- the name, address, and telephone number of the manufacturer or importer
- the brand name and the common name, classification name, or usual name of the device and the intended use of the device
- marketing status of the device
- the model, catalog, or code number of the device and the manufacturing lot or serial number of the device or other identification number
- the manufacturer's name and contact information
- a description of the event(s) giving rise to the information reported and the corrective or removal actions that have been, and are expected to be taken
- any illness or injuries that have occurred with use of the device
- the total number of devices manufactured or distributed subject to the correction or removal and the number in the same batch, lot, or equivalent unit of production subject to the correction or removal
- the date of manufacture or distribution and the device's expiration date or expected life
- the names, addresses, and telephone numbers of all domestic and foreign consignees of the device and the dates and number of devices distributed to each such consignee
- a copy of all communications regarding the correction or removal and the names and addresses of all recipients of the communications
- if any required information is not immediately available, a statement as to why it is not available and when it will be submitted
Even if such actions are not required to be reported to FDA, under 21 CFR 806.20(a), manufacturers are still required to keep a record of the correction or removal, though the report does not need to be submitted.
Electronic Submission: Coming Soon
All 806 reports have traditionally been sent to FDA in paper format by mail-a relatively archaic process considering the vast majority of FDA's forms, including its adverse event reporting forms which are similar in nature to the 806 forms, may be submitted electronically.
However, that anachronism will soon change if FDA gets its way. In June 2013, FDA proposed the creation of an "electronic process for submitting 806 reports" on a voluntary basis.
While paper-based reporting would still be permitted, FDA said it expected that the electronic filing of Form 806s would enhance the consistency of the data it receives and expedite the submission process.
That process, it added, would result in process efficiencies, though it is not yet clear how much time-if any-would be saved by FDA or industry. "We believe that submitters will find the electronic submission process to be user friendly and that it will enhance the consistency of submission data," FDA wrote. "We estimate that an electronic report will take the same amount of time for the submitter as a paper report takes."
As conceived of by FDA, the process of electronic reporting would require users to establish a "WebTrader" account and a digital verification certificate, which would then be valid for up to three years. This certificate would need to be purchased, but otherwise the electronic submission process does not establish any other costs or burdens on the manufacturer.
Establishing the account may take as long as two weeks, per FDA's estimation, and sponsors will be required to submit paper-based reports during that time period.
The reports would be sent to FDA using its widely used "eSubmitter" system, formally known as its electronic submission gateway (ESG).
FDA's Center for Devices and Radiological Health (CDRH) also expects to launch a website to provide online support and information about submitting the reports, it said.
While FDA received a handful of comments from industry regarding the changes, FDA brushed them aside as either unwarranted or not substantial enough to require changes to be made.
For example, one commentator said FDA's estimate of benefits had not taken into account that some companies would have to institute a system to use FDA's electronic submission system. FDA disagreed, saying most companies that deal with FDA already use the eSubmitter system for other applications, and would thus "already have compatible systems and would be familiar with FDA's ESG."
Accordingly, FDA said it has submitted its electronic 806 reporting request to the Office of Management and Budget (OMB), which will likely provide a response to FDA sometime after May 2014. FDA is accepting additional comments on the proposal until 28 April 2014.
Federal Register Notice