Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Conformity And Confidence: US FDA Seeks To Build Trust In Pre-Market Standards Declarations With ASCA Pilot

Executive Summary

FDA hopes the Accreditation Scheme for Conformity Assessment pilot will make it easier to trust the declarations of conformity to standards that are made by device-makers in pre-market submissions, rather than having to ask a lot of time-consuming questions. ASCA, included in the latest FDA user-fee agreement, also has important implications for the agency's global harmonization efforts. But many questions remain about its value and viability; they were on display at a recent two-day workshop at the agency's headquarters.

You may also be interested in...



Draft Guidance Doc From FDA Details Lab Accreditation Pilot

The US FDA detailed its proposed approach to the Accreditation Scheme for Conformity Assessment in a new draft guidance document. The ASCA will allow accredited labs to certify that manufacturers meet international conformance standards, which the agency hopes will help streamline the device approval process.

A Promise Kept? FDA Gives Some Leeway On 'Promissory' Statements In Consensus Standards Final Guidance

A final guidance from US FDA details when underlying data or supporting documentation must accompany a declaration of conformity to a consensus standard in a pre-market submission, and it offers a bit more wiggle-room than the agency previously proposed on the prospect of a promissory note pledging future conformance with a standard.

Proposed FDA Guidance Would Provide Alternate Route For 510(k) Applications

US FDA has proposed new requirements for its abbreviated 510(k) program that could help certain sponsors get clearance for their products without having to compare to predicate devices.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

MT122728

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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