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Contains Nonbinding RecommendationsRequests for Feedback on Medical Device Submissions: The PreSubmission Program and Meetings with Food and Drug Administration Staff Guidance for Industry and Food and.

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The FDA's Q-Submission Program provides submitters an opportunity to have early collaboration and discussions about medical device submissions. ... It also provides an opportunity for submitters to discuss issues communicated by the FDA during review of other submission types, such as submission hold letters.

A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate. the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.

A Pre-Sub is appropriate when FDA's feedback on specific questions is necessary to guide product development and/or submission preparation. The program is entirely voluntary on the part of the submitter. ... FDA has found that feedback is most effective when requested prior to execution of planned testing.

In any case, the basic definition of what a Pre-Submission is remains the same. It is a formal written request from an applicant/sponsor for feedback from FDA to be provided in the form of a formal written response, meeting or teleconference in which the feedback is documented in meeting minutes.

A 510(k) submitter should submit one electronic copy or eCopy of its 510(k) to CDRH's or CBER's Document Control Center (DCC). The current mailing address for CDRH's DCC and a link to CBER's DCC's mailing address are provided on the eCopy Program for Medical Device Submissions webpage.

In a brief paragraph, let the journal know why you are writing and why you are writing to them in particular. Begin by saying that you want to know whether your article is suitable for this journal. Provide the title and use the receiving journal's name so they know you have written an individualized email.

The FDA approval process can take between one week and eight months, depending on whether you self-register, submit a 510(k) application, or submit a Premarket Approval (PMA) application. Bringing a medical device to market is not a fast process.

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232