FDA Strategies to Implement & Enforce the Food Safety Modernization Act

This FSMA webinar will explore FDA’s anticipated enforcement strategy following finalization of the Hazard Analysis and Risk-based Preventive Control (HARPC) regulations for manufactured foods. The final rule will require that each food facility identify a “Qualified Individual” to conduct a multi-factor hazard analysis, then design and implement a written plan to control significant hazards.

The HARPC rules for human and animal feed are scheduled to be published in August 2015 and will become effective 60 days thereafter, with enforcement to follow 12 to 36 months later, depending on company size.

FDA’s New Medical Device Regulations 

By EAS Senior Consultant Kevin Walls

The Food and Drug Administration has recently implemented two new rules that affect all medical device manufacturers, initial distributors and repackager/relabelers.

The first new rule that went into effect on September 24, 2014, but up until now affected fewer than 10 percent of medical device manufactures, initial distributors and repackager/relabelers, is the Unique Device Identification (UDI) System. The agency is phasing in the UDI system over seven years. The new rule, established under 21 CFR Part 830, requires labels and device packages of medical devices distributed in the United States to include a UDI including easily readable plain text and Automatic Identification and Data Capture (AIDC) technology – usually a bar code.

The UDI rule also requires specified product information be submitted to FDA’s Global Unique Device Identification Database (GUDID). Most of the information in GUDID will be made available to the public. According to FDA, when fully implemented, the UDI system will serve several important public health objectives:

  • It will facilitate the healthcare community, industry, and the public’s rapid and accurate identification of a device using the UDI that appears on the device’s label and device package.
  • Medical providers, patients and others will be able to more easily access important information concerning the device, thereby reducing medical errors.
  • It will allow more accurate reporting, reviewing, and analyzing of adverse event reports so that problems can be identified and corrected more quickly.
  • It will provide a standard and clear way to document device use in electronic health records, clinical information systems, claims data sources and registries, leading to a more robust postmarket surveillance system which can be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
  • It will enable manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.

FDA has accredited certain Issuing agencies to operate a system for the issuance of unique device identifiers. The information contained in the UDI must also be submitted to FDA using the GUDID. The manufacturer, initial distributor or repackager/relabeler whose name appears on the device label is considered the labeler and is responsible for complying with this new requirement. The labeler must designate an individual as the Regulatory Contact, which may be an employee of the labeler or a consultant. The Regulatory Contact is responsible for making sure that the labeler meets GUDID submission requirements.

EAS Consulting Group can assist your company by playing the role of Regulatory Contact or by acting as your company’s Third Party Submitter to submit your products’ UDIs to the GUDID.

electronic Medical Device Reports (eMDRs)

The second new rule, which goes into effect on August 13, 2015, is related to electronic Medical Device Reports (eMDRs), which is covered under 21 CFR Part 803. According to the FDA “Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions.” The new rule requires that all MDR reports MUST be filed electronically using FDA’s Electronic Submissions Gateway (ESG). In order to submit eMDRs via FDA’s ESG, you must either set up a Web Trader Account or work with a consulting firm that has a Web Trader Account.

EAS can help you set up a Web Trader Account so you can generate and submit eMDRs, or can generate and submit eMDRs for your company using EAS Consulting Group Web Trader Account.

FDA Seeks Input on Proposed User Fees for Accreditation of Third-Party Auditors

The Food Safety Modernization Act requires the Food and Drug Administration to establish an accreditation program to strengthen foreign food safety audits. The agency issued a proposed rule for an accreditation program on July 29, 2013. In a related July 24, 2015 notice, the agency released a proposed rule that would introduce user fees to pay for the new program.

FDA anticipates issuing a final accreditation rule in October 2015 and it is inviting public comment by October 7, 2015 on the proposed user fees. The agency lists four main groups for the purposes of the “reimbursement” charges:

  • Accreditation bodies submitting applications or renewal applications for recognition in the third-party accreditation program;
  • Recognized accreditation bodies participating in the third-party accreditation program subject to FDA monitoring activities;
  • Certification bodies submitting applications or renewal applications for direct accreditation; and
  • Accredited certification bodies (whether accredited by recognized accreditation bodies or by FDA through direct accreditation) participating in the third-party accreditation program subject to FDA monitoring activities.

Under the agency’s July 24 proposal, accreditation bodies and certification bodies would be subject to application fees for the estimated average cost of the work FDA performs in reviewing and evaluating applications. Alternatively, the agency could charge an hourly rate or could use a combination of those two methods.

FDA estimates that it would take, on average, 60 person-hours to review an accreditation body’s application, 48 person-hours for an onsite performance evaluation of the applicant and 45 person-hours to prepare a written report documenting the onsite audit.

To provide a sense of the proposed fees — which the agency expects to finalize in the fall – it proposes $202 as the base unit fee in determining the hourly fee rate, prior to including domestic or foreign travel costs. With an estimated hourly travel cost of $103, the total fee would be $305 per paid hour for each direct hour of work requiring foreign inspection travel and most applications are likely to involve foreign travel. The agency proposes to set lower hourly rates for domestic travel.

The agency is also considering whether it should establish a flat fee or an hourly rate and is inviting comments on which approach is likely to work best in terms of encouraging high-quality applications.

If it bills using the actual number of hours worked, applications that are faster to review – because they are better-prepared, for example — could result in lower fees, while applications that are slower to review — because they are less organized or require more back-and-forth with the applicant — could result in higher fees, the agency notes.

Similarly, applicants that facilitate the onsite audit process and have higher quality operations would likely have shorter onsite audits than other applicants.

The agency is also considering whether it should have hourly fees for the onsite audit while maintaining a flat fee for other activities, such as the paper application review. This hybrid approach may be most consistent with how accreditation bodies currently charge certification bodies and could “provide a balance of predictability and incentives,” the agency suggests.

Along with the Foreign Supplier Verification Program, the recognition of third parties by FDA to perform audits and inspections is central to FSMA’s goal of achieving parity between domestic and imported food safety programs. By charging user fees, FDA is less reliant on Congressional appropriations, and in the process new jobs will be created in the private sector with the ultimate result of improved food safety. Sounds like a win-win-win to me!