Borghese & Associates Inc.
At present, participation in the eMDR program is voluntary; industry response has been less than enthusiastic. In FY07, FDA received only 15 eMDRs, Don St. Pierre, head of FDA's Postmarket Transformation Management Group, told attendees at the annual Regulatory Affairs Professionals Society meeting in September, according to the October 1 Gray Sheet. And the reports all came from the same company!
Clearly, industry has some issues with this process. What challenges will it face when the eMDR program becomes mandatory?
- As a practical matter, most firms will continue to keep paper files of MDR-related case material. This is because all records related to the case, including hand-written telephone notes as well as all deliberations and decision-making processes, must be kept.1 The practical solution for most firms will be to continue to keep a manila folder containing all related documentation including a print-out of the submitted MDR or the rationale for not submitting one.
- Companies must allow FDA access to their MDR-related records.2 In an entirely electronic system this would mean allowing FDA to access, copy, and verify data directly from a firm's computer system. It may be against company policy to allow an external agency direct access to its computer system because of the inability to stamp copied material as "confidential" and because a computer virus could be introduced.
- Many start-up and small medical device companies receive few adverse event reports. Indeed, some have never submitted an MDR. For these types of firms, the computer software may be incidental to the preparation of the paper MDR and would not have to be validated to comply with 21 CFR Part 11, electronic records. However, if electronic MDRs become mandatory, then all submissions to FDA must be Part 11—compliant, according to FDA guidance.3 Complying with Part 11 will be an added challenge and expense for small firms.
- Most firms send paper MDRs to FDA via private couriers such as FedEx, UPS, or DHL, which provide tracking numbers and receipts. Will the proposed mandatory eMDR program provide adequate evidence of receipt?
- Copies of the required device incident records must be kept for two years or a period of time equivalent to the expected life of the device, whichever is greater.4 For many medical devices, this could mean retaining electronic records for 10 or more years. Some of the media used to currently archive electronic records have not been validated to last 10 years. Changing technology adds to the challenge of ensuring ready access in the future, requiring plans to recopy and reformat. The media may well outlast the hardware!
Make no mistake about it: eMDRs are going to happen. They will become mandatory not only because FDA benefits, but also because it is part of a larger trend toward paperless documentation. However, let's be cognizant of the challenges that industry faces and not be overly hasty with a mandate before industry has had ample opportunity to comment on the proposal and prepare to implement it.
Robert N. Borghese is president of Borghese & Associates Inc., a consulting firm serving the medical device and biopharmaceutical industries. For more information about the firm, visit the company's listing in the online Consultant's Directory or go to the firm's Web site at www.consultborghese.com.
1. 21 CFR 803.18(b)(1)(i)
2. 21 CFR 803.18(d)(3)
3. Guidance for Industry Part 11, Electronic Records; Electronic Signatures-Scope and Application, FDA, August 2003, (www.fda.gov/cder/guidance/5667fnl.pdf)
4. 21 CFR 803.18(d)(2)