| Beginning August 14, 2015, device makers must |
submit all medical device reports electronically.
by Alex Butler, Product Manager
Life Science Applications (LS APPs), MasterControl
In February of 2014, the FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit initial and supplemental MDRs in an electronic format via the Electronic Submissions Gateway (ESG), rather than in paper form through Form FDA 3500A. The compliance deadline of August 14, 2015, is fast approaching! Will you be ready?
Here are some last minute tips for going all electronic.
Tip #1: Set Up Your ESG Account ASAP
There are two options available for reporters to submit eMDRs: through the eSubmitter tool, which can be downloaded for free from the FDA’s website, or the Health Level 7 (HL7) Individual Case Safety Reporting (ICSR) tool. To determine which option is best for you, consider how frequently you submit reports. The HL7 ICSR is intended for use for high volume reporting, i.e., batch records, while the eSubmitter tool is for low volume reporting, i.e., single reports.
Regardless of the reporting method you choose, all eMDRs must be submitted through the ESG, which authenticates and validates the electronic submission and routes it to the Center for Devices and Radiological Health (CDRH). If you haven’t set up your ESG account, do it today! It can take up to two weeks to complete the registration process, and you should allow additional time for testing. More information about the ESG registration process is available here.
This article is related to the Whitepaper: Five Trends Transforming the Medical Device Industry in 2015.To get the full details, please download your free copy.
Tip #2: Do Your Prep Work
Before you can even set up your account, there are a number of preparatory activities you must address, including:
- Submit a Letter of Non-Repudiation Agreement: You must complete and submit a letter of non-repudiation stating that all electronic signatures are legally binding. The letter, which is mandated by 21 C.F.R. Part 11.100, must be physically mailed (preferably on company letterhead) to the FDA’s ESG Support Team. Sample letters are provided on www.fda.gov.
- Obtain a Digital Certificate: A digital certificate is an electronic document which conforms to the International Telecommunications Union’s X.509 specification. It typically contains the owner’s name and public key, the expiration date of the public key, the serial number of the certificate, and the name and digital signature of the organization which issued the certificate. The digital certificate binds together the owner’s name and a pair of electronic keys (a public key and a private key) that can be used to encrypt and sign documents. The ESG system requires certificates with a key length of 1024 or 2048 or 3072, other lengths are not accepted. Detailed instructions for using and obtaining certificates are available here.
Tip #3: Know How to Troubleshoot Common Errors
This late in the game, time is of the essence. Fortunately, the FDA has compiled a list of the most common submission errors received from the ESG along with helpful troubleshooting tips. Take a few minutes to review the list prior to submitting. This knowledge will enable you to resolve issues faster—or avoid them altogether.
Tip #4: Don’t File For an Extension
If you don’t have all of your ducks in a row, you might be tempted to file for an extension or variance. My advice is to resist the temptation. Although requesting an extension or variance is permissible, the amount of work that’s required to secure a reporting modification is comparable to the amount of work required to meet the deadline in the first place. Per 21 C.F.R. §803.19: Exemptions, Variances, and Alternative Reporting Requirements, “Manufacturers, importers or user facilities may request exemptions or variances from any or all of the reporting requirements in this part. The request shall be in writing and include information necessary to identify the firm and device, a complete statement of the request for exemption, variance or alternative reporting, and an explanation why the request is justified.”
If you are prone to procrastination, having a deadline is often the push you need to get a task done. So, bite the bullet, follow these tips and start submitting. Additional information can be gleaned from Questions and Answers about eMDR—Electronic Medical Device Reporting, the Q&A guidance document that was released along with the final rule, provides step-by-step instructions for preparing and submitting your MDR. Other things covered in the document are: how to update reports, how to tell if your submission was successful, and how to handle system outages.
As product manager of life science applications (LS APPs), Alex Butler is responsible for developing and/or improving several MasterControl QMS solutions, including MasterControl Complaints, Bill of Materials (BOM), Projects, Risk and PDM Connector. Prior to joining MasterControl, Butler worked as a product development manager for Opal Orthodontics, a division of Ultradent Products Inc., where he helped launch several Class II medical devices, including the Opal Espirit™ Class II Corrector. With more than four years of direct medical device experience, as well as a deep understanding of the FDA’s submission process and audit procedures, Butler is a welcome addition to the MasterControl team.