510 K Submissions Medical Devices

510(k) Submission Process | FDA

https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process

The FDA follows the MDUFAperformance goals for review of 510(k) submissions. When you submit a 510(k) submission to CDRH for review, your official correspondent can monitor the FDA's progress online in a simple, concise format. For more information, see Send and Track Medical Device … See more

510(k) Submission Programs | FDA

https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-programs

Premarket Notification 510(k) | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k

A new 510 (k) submission is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or …

Electronic Submission Template for Medical Device …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-510k-submissions

FDA is identifying October 1, 2023 as the date on which we will require that 510 (k) electronic submissions be provided. FDA intends to accept 510 (k) …

510(k) Clearances | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances

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 …

Content of a 510(k) | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k

Identify the submission as a Traditional, Special, or Abbreviated 510 (k). Submitter name, address, phone, fax and e-mail address. If the person who intends to market the device …

510(k) Frequently Asked Questions | FDA

https://www.fda.gov/medical-devices/premarket-notification-510k/510k-frequently-asked-questions

510 (k) Frequently Asked Questions | FDA 510 (k) Frequently Asked Questions Distributors Foreign Manufacturers Registration Quality System Distributors I would like to distribute a...

Acceptance Checklists for 510(k)s | FDA

https://www.fda.gov/medical-devices/premarket-notification-510k/acceptance-checklists-510ks

Acceptance Checklists for 510 (k)s The Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy for 510 (k)s describes the criteria FDA …

FDA Submissions - What are 510(k), PMA, De Novo, Pre …

https://kenblockconsulting.com/fda-submissions

FDA Submissions - What are 510 (k), PMA, De Novo, Pre-Subs? FDA Submissions Several types of premarket submissions can be made to FDA. In order to legally market …

Medical Device Exemptions 510(k) and GMP Requirements

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/315.cfm

Medical Device Exemptions 510 (k) and GMP Requirements FDA Home Medical Devices Databases Introduction Following is a breakdown of 510 (k) exempt and Good …