Pre-market information from the Division of Industry and Consumer Education (DICE) at FDA’s Center for Devices and Radiological Health (CDRH): The Device Advice and CDRH Learn webpages are educational tools for medical device regulations including marketing, premarket and post-market requirements.
The CDRH Learn webpage contains module in the form of presentation or PowerPoint, etc. under heading “how to study and market your device”:
Additionally, see “Medical Device Webinars and Stakeholder Calls” using the following link:
Medical Device Overview: https://www.fda.gov/industry/regulated-products/medical-device-overview
21st Century Cures Act: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
SEC. 3060. CLARIFYING MEDICAL SOFTWARE REGULATION.
(a) IN GENERAL.—Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amended by adding at the end the following: (o) REGULATION OF MEDICAL AND CERTAIN DECISIONS SUPPORT SOFTWARE.— (1) (A) – (E)
Software as a Medical Device (SAMD): Clinical Evaluation – Guidance for Industry and Food and Drug Administration Staff (December 2017) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/software-medical-device-samd-clinical-evaluation-guidance-industry-and-food-and-drug-administration
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff (October 2, 2014) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-management-cybersecurity-medical-devices
Some highlighted links on the Medical Devices site
Resources for You
All Medical Device Databases
Search for Guidances
Classify a Medical Device
Study and Market a Device
As you become familiar with these pages, you will see that there is overlapping information and different ways to get the same information.
Please see the links below for specific submission information:
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, Guidance for Industry and Food and Drug Administration Staff (May 2019) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program [fda.gov]
Refuse to Accept Policy for 510(k)s https://www.fda.gov/media/83888/download [fda.gov]
Premarket Notification 510(k) https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k [fda.gov]