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Global Medical Device RA/QA News

US Regulators Plan Overhaul of Third-Party 510(k) Review Program

EMERGO SUMMARY OF KEY POINTS:

  • US FDA is amending its 510(k) third-party review program 3PRO to reduce the need for agency re-reviews of these submissions and market entry delays.
  • As part of the 3PRO overhaul, FDA will adjust its list of eligible devices to focus more on lower-risk, less complex products.
  • By 2021, FDA wants 85% of 3PRO-reviewed 510(k) submissions to go through without the need for agency re-review.

The US Food and Drug Administration has set a goal of obviating the need to re-review 85% or more of 510(k) applications...

Source | Stewart Eisenhart
Sep 17, 2018
United States | Medical Devices

US FDA Proposes Single, Electronic Submissions for Medical Device Market Applicants

EMERGO SUMMARY OF KEY POINTS:

  • US FDA wants only electronic submissions for most medical device premarket applications.
  • US regulators currently require both paper and electronic copies of 510(k) and other premarket submissions.
  • FDA will accept both eCopy and eSubmission formats as qualified electronic submissions.

Medical device regulators at the US Food and Drug Administration intend to eliminate requirements for paper and multiple copies of premarket applications in favor of single electronic submissions for agency review.

The...

Source | Stewart Eisenhart
Sep 13, 2018
Canada | Medical Devices

Health Canada to Offer Pre-clinical Advisory Meetings to Medical Device Manufacturers

 

EMERGO SUMMARY OF KEY POINTS:

  • Health Canada’s Pre-Clinical Meeting program to provide feedback and recommendations to medical device manufacturers before they undertake clinical investigations.
  • Pre-Clinical Meeting program pilot to run from November 2018 to March 2019.
  • Formal Pre-Clinical Meeting guidance to be published following program pilot.

Canadian medical device regulator Health Canada is preparing a pilot for a new program allowing manufacturers to request meetings with the agency for feedback on proposed clinical...

Source | Stewart Eisenhart
Sep 11, 2018
United States | Medical Devices

US FDA Rolls Out Pilot for Simplified 510(k) Submissions

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has launched a pilot program for streamlined 510(k) reviews using its eSubmitter software.
  • Eligible premarket notification applicants are not required to submit paper copies of their premarket applications to FDA.
  • FDA has set 60-day review timeframes for 510(k) applications submitted through the program, versus 90 days for standard 510(k) application routes.

The US Food and Drug Administration announced a new pilot program allowing qualified 510(k) medical device registrants to submit only...

Source | Stewart Eisenhart
Sep 10, 2018
Brazil | Medical Devices

Brazil’s ANVISA Readies Regulations for Custom-made Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • ANVISA rolling out new regulations for custom-made medical devices
  • Requirements will cover commercialization, importing and manufacturing of such devices
  • The new regulations will replace ANVISA’s current “special request” process for custom and patient-specific devices

ANVISA, Brazil’s medical device market regulator, has issued a public consultation to establish new requirements pertaining to custom-made devices.

The new...

Source | Stewart Eisenhart
Sep 6, 2018
Australia | Medical Devices

Australian TGA to Accept Medical Device Approvals from Additional Overseas Regulators

EMERGO SUMMARY OF KEY POINTS:

  • Australia’s Therapeutic Goods Administration (TGA) plans to begin accepting certifications and approvals from additional foreign medical device regulators in addition to European CE Marking from market applicants.
  • TGA will recognize registrations and certifications from US FDA, Health Canada, the Japanese Pharmaceutical and Medical Devices Agency (PMDA) and Medical Device Single Audit Program (MDSAP) auditing organizations.
  • Australian market applicants may leverage approvals and registrations from these agencies for expedited TGA
  • ...
Source | Stewart Eisenhart
Aug 30, 2018
China | Medical Devices

China FDA Simplifies Documentation Requirements for Renewals, Clinical Trial Applications

EMERGO SUMMARY OF KEY POINTS:

  • The China Food and Drug Administration (CFDA) has loosened some requirements in Order No. 43 pertaining to registration renewal and clinical trial application documentation.
  • Changes affect analysis reports for renewals as well as home country and ethical committee approvals for clinical trials.

Chinese medical device market regulators have amended requirements for documentation related to registration renewals as well as clinical trial applications to simplify compliance.

First, according to Emergo...

Source | Stewart Eisenhart
Aug 24, 2018
Egypt | Medical Devices

Expanded Medical Device Regulations in Egypt Set for September 2018

EMERGO SUMMARY OF KEY POINTS:

  • Egypt’s Central Administration of Pharmaceutical Affairs (CAPA) will begin requiring registration for a broader swath of medical devices starting September 1, 2018.
  • All Class I sterile, Class IIa, Class IIb and Class III devices will fall under CAPA oversight.

Expanded medical device registration requirements in Egypt remain set to come into effect September 1, 2018, but affected companies should be familiarizing themselves now with new Central Administration of Pharmaceutical Affairs (CAPA) processes.

As...

Source | Stewart Eisenhart
Aug 22, 2018
FDA GUDID Update: Combination product deadline extension, database records reach 1.8 million EMERGO
United States | Medical Devices

FDA GUDID Update: Combination product deadline extension, database records reach 1.8 million

EMERGO SUMMARY OF KEY POINTS:

  • US FDA is delaying GUDID submission requirements for some combination products by one year, to 2019.
  • The delay impacts combination products that undergo premarket review by the Center for Drug Evaluation and Research (CDER).
  • The latest GUDID submission data does not deviate from trends first identified by FDA in March 2018.

...

Source | Stewart Eisenhart
Aug 17, 2018
Brexit Update: New UK MHRA Guidance for Medical Device Companies Emergo
United Kingdom | Medical Devices

Brexit Update: New UK MHRA Guidance for Medical Device Companies

EMERGO SUMMARY OF KEY POINTS:

  • If there is a deal reached regarding the relationship between the UK and the EU after March 29, 2019 (“Brexit Day”), a transition period will apply that will last until December 31, 2020.
  • The European Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR) will become applicable in the UK.
  • The Clinical Trials Regulation will most likely become applicable. Should the implementation be postponed until after December 31, 2020, this Regulation will become UK law anyway.
  • A “cliff edge” Brexit is still an
  • ...
Source | Ronald Boumans
Aug 15, 2018