510k

FDA Updates PMA and 510(k) Refuse to Accept Policy for Combination Products

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has updated its 510(k) Refuse to Accept and Premarket Approval acceptance policies for combination product submissions.
  • The updated guidances include new requirements for drug patent and exclusivity information.

New US FDA Guidance: How to Utilize the Dual 510(k) and CLIA Waiver IVD Market Pathway

EMERGO SUMMARY OF KEY POINTS:

  • New FDA recommendations issued for IVD manufacturers using the Dual 510(k) and CLIA Waiver by Application registration pathway.
  • The FDA’s Dual Submission pathway allows IVDs to reach the US market faster than if registrants obtain 510(k) clearance and then CLIA waived categorization in a stepwise process.
  • The Dual Submission registration pathway is best suited for simple IVDs  subject to 510(k) rather than Premarket Approval (PMA) review.

Final FDA Guidance on When Medical Device Changes Require New 510(k) Submissions

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has issued final guidance documents for changes to medical device hardware and software that require new 510(k) applications.
  • The final guidances do not differ substantially from draft versions published in 2016.

MDUFA IV: Most US FDA user fees for medical device companies jump 33% or more in 2018

EMERGO SUMMARY OF KEY POINTS:

  • FDA user fees for the 2018 fiscal year have increased across all registration categories.
  • 510(k) fee paid by companies that don't qualify for small business discount will more than double.
  • Annual Establishment Registration fee increasing 37% with no discount for small businesses.

FDA Pre-Cert Pilot for Medical Software: Key Questions and Eligibility Criteria

EMERGO SUMMARY OF KEY POINTS:

  • The US FDA will begin its Pre-Certification for Software (Pre-Cert) pilot program for digital health technologies considered medical devices in September 2017.
  • Eligibility requirements for Pre-Cert participation as well as frequently asked questions have been published.
  • As of now, US regulators have not set a deadline for applying to participate in the Pre-Cert program.

US FDA Finalizes Class II Medical Device Exemptions from 510(k) Premarket Notification Requirements

EMERGO SUMMARY OF KEY POINTS:

  • List of Class II medical devices exempt from 510(k) requirements now finalized by US FDA
  • More than 1,000 devices are now exempt from 510(k) premarket notification requirements
  • The FDA first proposed these 510(k) exemptions in March 2017.

New Round of Class I FDA 510(k) Exemptions: Limited Impact

EMERGO SUMMARY OF KEY POINTS:

  • US regulators have exempted 71 Class I medical device product codes from 510(k) clearance requirements.
  • The new exemptions are limited in scope, primarily affecting manufacturers of analyte control products.

Proposed US FDA User Fee Increase would Impact Smaller Medical Device Firms the Most

EMERGO SUMMARY OF KEY POINTS:

  • The Trump Administration has proposed user fee increases for drug, medical device and other FDA registrants in 2018.
  • Few specifics on the proposed increases make it difficult to determine exactly how medical device firms would be impacted.
  • Smaller manufacturers make up the vast majority of the US medical device industry, and would be most substantially affected by higher FDA fees.

When Medical Device Software Changes Warrant a new FDA 510(k)

US medical device market regulators have clarified their recommendations for when changes to software or firmware should prompt a manufacturer to file a new 510(k) premarket notification for a medical device.

Emergo Analysis: Fewer 510(k) Submissions from US Medical Device Firms in 2015

In 2015, fewer US-based medical device companies submitted 510(k) applications to the Food and Drug Administration than at any point in the last five years.

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