Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA officials summarise the agency's advance:

This article was originally published in Clinica

Executive Summary

The investigational device exemptions granted by the FDA within 30 days of submission have more than doubled to 73 in the past three years. The backlog of PMA supplements, which authorise companies to make significant changes to high-risk devices, has been reduced by a factor of 10 in the same period. The backlog of 510(k) submissions, for which the agency must determine whether the technology described has substantial equivalence to existing products, is now one a month at most, compared with 2,000 in 1993.

You may also be interested in...



Lucky STAR: FDA’s eSTAR Pilot Aims To Make 510(k) Process Smoother With Submission Template For Device Makers

Nine lucky manufacturers will soon have the chance to enroll in a voluntary eSTAR pilot program that the US agency says will make the premarket review process more efficient and consistent. The design and structure of an electronic Submission Template And Resource – or eSTAR – template is similar to templates used by FDA reviewers. An eSTAR won’t change the agency’s statutory or data requirements for sponsors to show substantial equivalence to predicate devices.

E.l.f. Puts Premium On ‘Clean Beauty’ With First Strategic Acquisition: W3ll People

W3ll People is expected to add a relatively modest $7m to e.l.f. Beauty’s fiscal 2021 top line, but the brand has “major white space” opportunities, including at Target, e.l.f.’s longest-standing customer. Further, its plant-based product line includes 40 “EWG Verified” products, reflecting expertise e.l.f. is eager to tap.

UCB Pins Growth Hopes On Burgeoning Late-Stage Pipeline

UCB's R&D efforts include late-stage diverse but complementary immunologicals and anti-neuroinflammatories.

 

Topics

UsernamePublicRestriction

Register

MT084566

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel