{{ phone }} {{ location }}

Emergo by UL logo


Global Medical Device News

United States | Medical Devices

US FDA Launches Pilot to Expand Special 510(k) Market Pathway


  • US FDA launching pilot program to expand Special 510(k) route for modifications to medical devices.
  • Pilot would allow more types of device changes to qualify for simplified Special 510(k) route.
  • All Special 510(k) submissions received by FDA from October 1, 2018 will be considered for participation in pilot.

Medical device regulators at the US Food and Drug Administration has initiated a new pilot program for expanded eligibility in the agency’s Special 510(k) pathway, potentially easing market compliance...

Source | Stewart Eisenhart
Oct 3, 2018
Europe | Medical Devices

Effects of “No Deal” Brexit for Medical Device Sector


  • A “no deal” or “Cliff Edge” Brexit is a realistic scenario, becoming more realistic every day.
  • The UK government issued documents about preparing for this Cliff Edge scenario.
  • This scenario can affect companies all over the world, as they may depend on certificates issued by UK-based Notified Bodies or use a UK-based Authorized Representative (AR).
  • Companies using a UK-based AR and UK-based companies exporting to the EU will need an EU-based AR.
  • It is likely an AR is also required for non-UK companies placing
  • ...
Source | Ronald Boumans
Sep 26, 2018
India | Medical Devices

India Medical Device and IVD Regulatory Update: September 2018


  • India’s Central Drugs Standard Control Organization (CDSCO) plans to rename itself.
  • CDSCO has also published new guidance documents on Medical Device Regulations, 2017 compliance and performance evaluations for IVDs.

Indian regulators have recently announced several updates regarding their medical device and IVD oversight programs.

CDSCO renaming

First, CDSCO plans to rename itself to more accurately convey its...

Source | Stewart Eisenhart
Sep 21, 2018
United States | Medical Devices

US Regulators Update Policies for Medical Device Voluntary Consensus Standards


  • US FDA draft guidance explains agency’s process for recognizing voluntary consensus standards used for medical device declarations of conformity.
  • The guidance describes FDA’s process and criteria for determining complete or partial recognition or non-recognition of consensus standards.

The US Food and Drug Administration’s medical device regulatory division has issued new guidance clarifying how it recognizes and withdraws voluntary consensus standards.

FDA’s Center for Devices and Radiological Health (CDRH...

Source | Stewart Eisenhart
Sep 20, 2018
United States |

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


  • 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


  • 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.


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

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



  • 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


  • 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
Europe | Medical Devices

MDR Analysis: Does your medical device fall under the scope of new European regulations?

Now that the European Medical Device Regulation (MDR) is widely available, manufacturers and other industry participants can more accurately predict key issues that will affect them—including how and whether the scope of the new regulations covers their devices.

Note: This blog post was updated in October 2018 for accuracy.

The MDR text (see page 13 for the definition) as well as its accompanying Annex XVI (page 117) lay out clear indications as to which types of devices will have to...

Source | Ronald Boumans and Stewart Eisenhart
Sep 9, 2018
Brazil | Medical Devices

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


  • 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