Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

New FDA draft guidance on premarket submissions.

M E Donawa1

  • 1Donawa and Associates, Ltd., Rome, Italy.

Medical Device Technology
|March 21, 2000
PubMed
Summary

The US Food and Drug Administration (FDA) released draft guidance on quality system information for premarket device submissions. Manufacturers should review this guidance and submit comments to the FDA.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

The quality planning conundrum.

Medical device technology·2000
Same author

Drug delivery: the strategic advantage of design controls.

Medical device technology·1999
Same author

Use and recognition of consensus standards in US premarket submissions.

Medical device technology·1999
Same author

An improved draft guidance to process validation.

Medical device technology·1999
Same author

Avoiding unreasonable reliance on subcontractor certification.

Medical device technology·1999
Same author

Notifying the competent authorities.

Medical device technology·1999

Area of Science:

  • Regulatory Affairs
  • Medical Device Quality Systems

Background:

  • The US Food and Drug Administration (FDA) governs medical device approval processes.
  • Quality system information is crucial for ensuring device safety and efficacy.

Purpose of the Study:

  • To inform manufacturers about the FDA's draft guidance on quality system information for premarket submissions.
  • To encourage manufacturers to provide feedback on the draft guidance.

Main Methods:

  • Analysis of the FDA's draft guidance document.
  • Discussion of the implications for medical device manufacturers.

Main Results:

  • The draft guidance specifies quality system information required for premarket submissions (e.g., 510(k) process).
  • This information aligns with data to be maintained at manufacturing facilities.

Conclusions:

  • Manufacturers must understand the requirements outlined in the draft guidance.
  • Timely submission of comments to the FDA is recommended to influence the final guidance.

Related Experiment Videos