This folio responds to accepted questions on online 506J notification acquiescence methods, including the webform and spreadsheet template, beneath area 506J of the Federal Food, Drug, and Cosmetic (FD&C) Act during the COVID-19 pandemic.
On this page:
Q. How do I abide notifications application the webform? Area can I acquisition advice if I accept agitation application the webform?
A. Amuse see the How to Use the FDA 506J Notification Webform for added advice on appointment advice through the webform, troubleshooting, and answers to frequently asked questions on the webform.
Q. Is the advice I abide application the webform secure?
A. The FDA 506J Notification webform complies with Hypertext Transfer Protocol Defended (HTTPS) messaging standards and uses agenda certificates for defended communication.
Q: What is the purpose of the “Voluntarily Announce No Current Abeyance or Abiding Discontinuance” advantage on the online webform?
A: If a architect is currently not experiencing an abeyance or abiding adjournment in manufacturing, they may voluntarily announce this to the FDA selecting this advantage and bushing out the form.
Q. Are there added means than the webform to abide a 506J Notification?
A. The FDA recommends application the webform to abide your notification. However, there are alternating methods to abide a 506J notification. For example, if you do not advance the webform, manufacturers may email their advice to [email protected] and activate the email accountable band with the chat “Notification.” Area V of the guidance, Advice CDRH of a Abiding Adjournment or Abeyance in Accomplishment of a Accessory Beneath Area 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised), provides an archetype 506J notification advised to allegorize the blazon of advice that the FDA recommends be included in a notification.
Q. I’m accepting agitation loading the anatomy in my web browser. Are there assertive web browsers that assignment bigger than others?
A. Amuse use Chrome, Microsoft Edge, or Firefox to ample out the webform. The webform does not abutment Internet Explorer.
Q. Can I see what advice I accept submitted previously?
A. No, already the webform is submitted, the advice is beatific to the FDA and is not adored aural the webform. If you accept a catechism about the advice you submitted, amuse email [email protected] and accommodate “Question” in the accountable band of the email.
Q. Can I use assorted methods to abide advice application the webform?
A. Yes, you can abide notifications through any or all of the three methods in the webform (for example, webform, spreadsheet, autonomous notification). Already you’ve completed and submitted notification application one method, you will be redirected to the webform home page, area you can baddest a altered method.
Q. How do I apperceive if the FDA accustomed my webform submission?
A. Already you accept submitted a 506J notification through the webform, a acceptance email will be beatific to the articular contact’s email address. To acquaint accessible acknowledgment efforts, the FDA may chase up with manufacturers or conduct targeted beat area an abeyance is cross-cutting or may accept the abeyant to appulse users. However, you will not commonly apprehend from the FDA already the FDA has analyzed the information.
The FDA will about acquaint updates to the accessory curtailment account and accessory adjournment list. Any advice that is barter abstruse or arcane advice will be advised as such, constant with area 552(b)(4) of appellation 5, United States Code, area 1905 of appellation 18, United States Code, area 520(c) of 21 USC 360J(c), and added applicative laws.
Q. What if I appetite to accommodate the FDA with added advice than is appropriate or requested? How can I abide that information?
A. When application the webform, you may attach added abstracts if there is added advice you ambition to accommodate to the FDA. Baddest “Add files” at the basal of the folio and the advantage to add accessories will become available.
Q. How do I abide a 506J notification for a artefact cipher that is not accessible on the webform?
A. If your artefact cipher is not available, amuse acquaintance the FDA for added apprenticeship at [email protected] and accommodate “Product Code” in the accountable line. Accommodate your name, organization, and acquaintance advice and an FDA aggregation affiliate will acquaintance you with instructions on how to abide your notification.
Q. How do I abide a 506J notification for an FEI that is not accessible on the webform?
A. If you are accepting agitation analysis your FEI number, see How to Determine FEI, artefact code, and acquiescence cardinal for advice on how to locate your firm’s enactment information. If you are still clumsy to locate your establishment’s FEI cardinal in the webform, amuse email [email protected] and accommodate “Question” in the accountable line.
Q. There are three altered notification options on the webform. How do I apperceive if I accept a “small” or “large” bulk of FEI-product codes to enter?
A. The FDA recommends appointment 506J notifications application the adjustment that is best acceptable for you.
Generally, for a architect accepting amid 5 and 10 FEI-product cipher combinations, appointment 506J notifications anon through the webform may be easiest.
For a architect accepting over 10 FEI-product cipher combinations, the spreadsheet arrangement may be a added acceptable adjustment to abide a 506J notification. You can again abide it to the FDA in your antecedent notification, as able-bodied as use it to aggregate any revised advice for amend notifications.
The webform is adapted account to accommodate new advice from Registration & Listing; however, the architecture of the spreadsheet will not change.
Q. I ran out of appearance amplitude in a box. How can I add added ambience to my answer?
A. If you accept exceeded the appearance absolute in a argument box field, an added book can be absorbed to your acquiescence that contains any added information. Amuse acquisition the advantage to attach a book at the basal of the form.
Q. What if the options for the acumen for abeyance don’t absolutely explain my situation?
A. You accept the advantage to baddest several affidavit for the adjournment or abeyance as able-bodied as an advantage of “Other.” An accessible argument acreage is beneath this catechism area you can explain the acumen for the adjournment or abeyance if you feel the options don’t explain your situation. Additionally, there is an advantage to attach a book at the end of your submission.
Q. Is there a way of advice the FDA that I do not currently accept an abeyance or abiding discontinuance?
A. Yes. If you are not currently experiencing an abeyance or adjournment in manufacturing, you may voluntarily acquaint the FDA application the “Voluntarily Announce No Current Abeyance or Abiding Discontinuance” advantage on the webform.
Q. Area can I acquisition added advice about 506J notifications?
A. See Medical Accessory Supply Chain Notifications During the COVID-19 Communicable for added advice about 506J notifications. For answers to frequently asked questions about the accessory curtailment list, who to contact, or 506J Notifications in general, amuse see Supplies of Medical Devices for COVID-19: Frequently Asked Questions.
Q. How do I abide ample numbers of notifications application the spreadsheet? Area can I acquisition advice if I accept agitation entering advice in the spreadsheet?
A. Amuse see the How to Use the 506J Notification Spreadsheet Arrangement for added advice on appointment advice through the webform, troubleshooting, and answers to frequently asked questions on the webform.
Q. Can I abide a spreadsheet that does not use the FDA spreadsheet arrangement application the webform?
A. No. Spreadsheet files that are not formatted in the FDA spreadsheet arrangement will not be able to be candy correctly. If you are experiencing problems with the FDA arrangement spreadsheet, email [email protected] and accommodate “Question” in the accountable line.
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