Posts by Virginia Anastassova

Virginia Anastassova

How to benefit from FDA ASCA (Accreditation Scheme for Conformity Assessment) Pilot Program

FDA launched their pilot  ASCA (Accreditation Scheme for Conformity Assessment) Program on September 25, 2020. The intent for the ASCA program is to utilize accredited third-party testing laboratories to assess premarket applicants’ declarations of conformity to consensus standards for safety, performance and biocompatibility. The final guidance outlining the accreditation scheme for the ASCA pilot program […]

Virginia Anastassova

FDA Breakthrough Devices Program Update and Advantages

The FDA Breakthrough Devices Program provides several advantages for novel devices that meet the inclusion criteria and can significantly reduce a product’s time to market. The Breakthrough Devices program implemented by FDA in 2018 has superseded the Expedited Access program that was introduced in 2015. The program is gaining popularity with 11 designations in 2016, 19 […]

Virginia Anastassova

510(k) submission: 9 Tips for success

A 510(k) submission is required in the receive clearance to market almost all class II medical devices.  While the 510(k) preparation process is not as onerous as preparing a Premarket Approval (PMA), it has its own challenges and pitfalls. We recently completed a 510(k) submission and I’d like to share some of the wisdom […]

Virginia Anastassova

Areas to consider when preparing for MDR 2017/745

Start early to avoid surprises Europe’s medical device directive (MDD) is changing as a result of MDR 2017/745 published on May 5, 2017. The new regulations will come into full force in Q2 2020, after a 3 year transition period. With over 300 pages, you probably have a lot of questions about preparing for MDR […]

Virginia Anastassova

7 Benefits of Using Adaptive Design for Clinical Studies

What is adaptive design for clinical study and why is the Medical Device community so excited about it? An adaptive design for a medical device clinical study is defined as a clinical trial design that allows for prospectively planned modifications based on accumulating study data without undermining the trial’s integrity and validity.

Virginia Anastassova

Expedited Access Pathway: timely medical devices for patients with life-threatening conditions

The Expedited Access Pathway (EAP) became effective on April 15th this year with the issue of the Food and Drug Administration (FDA or the Agency) guidance entitled  “Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.”

Virginia Anastassova

FDA reports faster medical device approval

The FDA is eager to show improvement of a performance self-assessment which revealed “a steady decline” of its premarket medical device approval program between 2000 and 2010. In a recent report on policies and initiatives, the FDA device arm (CDRH) claims it approves medical devices much faster than five years ago. The Agency also outlines […]

Virginia Anastassova

Meeting with the FDA

“We need a meeting with the FDA”. These words can put almost everybody in the company in panic mode. What data do we present? How long do we need to prepare the meeting package? Who will be presenting? Who will be attending the meeting? How much do we rehearse for the meeting?

Virginia Anastassova

Ready for next FDA UDI compliance date of September 24, 2015?

Unique Device Identifiers (UDIs) have been one of the hot topics in the Medical Device world in the last few years. The FDA requirements for UDIs became a reality last year with the first compliance date of September 24th, 2014 requiring the labels and packages of class III medical devices and devices licensed under the […]

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