FDA Industry Systems Access: Medical Device Portal Login

Navigating the regulatory landscape for medical devices in the United States requires engagement with several official U.S. Food and Drug Administration (FDA) digital platforms. These online systems are critical for manufacturers, importers, and other device-related establishments to maintain compliance and facilitate product distribution. This guide details how to effectively use the FDA's Industry Systems, including the Device Facility User Fee (DFUF) website, the FDA Unified Registration and Listing System (FURLS) with its Device Registration and Listing Module (DRLM), and the CDRH Customer Collaboration Portal (CDRH Portal), ensuring a smooth regulatory journey. These digital platforms are central to fulfilling obligations under the Medical Device User Fee and Modernization Act (MDUFMA) and subsequent amendments. They provide a streamlined way to manage everything from paying required fees to submitting vital premarket applications and tracking their review status. Understanding each system's function and how they connect is key to efficient operation and maintaining good standing with the FDA.

What Industry Entities Need to Access FDA Online Systems

• A valid Employer Identification Number (EIN) for U.S. firms or a Dun & Bradstreet Number (DUNS) for foreign firms is necessary for account creation. An Organization ID (Org ID) may also be used if previously issued.
• An active email address is required for login to the Device Registration and Listing Module (DRLM) within FURLS, as it's used for multi-factor authentication (MFA) and account verification.
• For medical device establishment registration, annual user fees must be paid. A Payment Identification Number (PIN) and Payment Confirmation Number (PCN) are generated upon payment, which are crucial for completing the registration process.
• Foreign establishments must appoint a qualified U.S. Agent for effective communication with the FDA.
• To ensure data privacy and security, users should have current antivirus and antispyware software installed on their computers when accessing FDA Industry Systems.

Securely Entering Your FDA Digital Account

1. Begin by visiting the official FDA Industry Systems portal at https://www.access.fda.gov/oaa/.
2. Review the 18 U.S.C. 1001 statement and select the "I understand" checkbox. Then, click the "Login" button to proceed.
3. Enter your FURLS Account ID and Password into the respective fields.
4. The system employs Multi-Factor Authentication (MFA). You will be prompted to receive a verification code, usually sent to the email address associated with your account. Click "Send Code".
5. Retrieve the verification code from your email (check spam if not received) and enter it into the designated box. Click "Submit Code".
6. Upon successful authentication, you will be directed to your FURLS "Account Management" home page. You may also have the option to set up a passkey for future logins, offering enhanced security and convenience.
7. For the CDRH Portal, specific for premarket submissions, register or sign in at https://fda-cdrh.okta.com/signin/register. Account registration and password reset requests for this portal will originate from an email ending in @okta.com.

Managing Your Medical Device Compliance Online

• Establishment Registration and Device Listing: Through the Device Registration and Listing Module (DRLM) within FURLS, establishments can annually register their facilities and list all medical devices produced or distributed.
• User Fee Payment Management: The Device Facility User Fee (DFUF) website facilitates online payment of annual registration fees and various premarket application fees.
• Premarket Submission and Tracking (CDRH Portal): The CDRH Portal allows for electronic submission of premarket applications (e.g., 510(k), De Novo, PMA, IDE) and Small Business Determination (SBD) requests. It also provides a dashboard for near real-time tracking of submission status.
• Account Management: Users can manage their account profiles, create subaccounts for official correspondents, and control access permissions within the FDA Industry Systems.
• Updating Information: The portals enable owners and operators to update registration and device listing details throughout the year as changes occur, such as introducing new devices or modifying manufacturing locations.
• Access to Guidance and Resources: The FDA websites linked to these portals offer comprehensive guidance documents, tutorials, and FAQs to assist users with compliance.

Resolving Access Challenges for FDA Industry Portals

Safeguarding Your FDA Portal Information

• 🔒 Always use a strong, unique password for your FDA portal accounts.
• 🔒 Enable Multi-Factor Authentication (MFA) whenever possible to add an extra layer of security beyond just a password.
• 🔒 Be cautious of phishing attempts. Account registration and password reset requests from the CDRH Portal will come from an email ending in @okta.com. Be skeptical of unexpected emails asking for login credentials.
• 🔒 Ensure your computer has up-to-date antivirus and antispyware software to protect your information when accessing FDA Industry Systems.
• 🔒 Avoid sharing your FURLS login credentials. If others need access, utilize official subaccount management functions provided by the system.
• 🔒 If you receive suspicious calls regarding your facility, obtain the caller's name and company, then contact the FDA FURLS Help Desk at 1-800-216-7331 to verify their legitimacy.

Common Inquiries on FDA Medical Device Portals