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New Medical Device Pathway: Safety and Performance Based Pathway

New Medical Device Pathway: Safety and Performance Based Pathway

In late 2019, the FDA introduced a new Safety and Performance Based Pathway which can potentially speed up the preparation and review process for certain submitters of pre-market notification medical device submissions. This optional pathway was created by the FDA to assist with well understood device types, in which a submitter references device specific guidance’s detailing the appropriate testing standards, as well as defined performance criteria to demonstrate the device is as safe and effective as a legally marketed device. Under the approach expanded in the Safety and Performance Based Pathway guidance, a submitter could satisfy the requirement to compare its device with a legally marketed device by, among other things, demonstrating that the device’s performance meets established performance criteria. These performance criteria are derived from FDA-recognized consensus standards, FDA guidance’s, scientific literature, special controls and historical 510(k) submission data. In all 510(k) submissions performance data is critical to proving a state of substantial equivalence to a predicate device and is often the most time consuming and complicated part...

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2020 Over-the-Counter (OTC) Drug Monographs Reform Summary

2020 Over-the-Counter (OTC) Drug Monographs Reform Summary

Over-the-Counter (OTC) drug monographs represent current regulatory standards for the marketing of non-prescription drug products not covered by new drug applications. These standards provide the marketing conditions for some OTC drug products including the active ingredients, labeling, and other general requirement in the US, OTC drug medicines making up around 60% of all medicines (Prescription (Rx) and Non-Prescription). Developed in 1972, the OTC monograph system has been instrumental in lowering the cost of entry and standardizing requirements across different formulations, however progress in moving forward in adding and amending monographs has not kept up with expectations of the FDA or industry mostly due to an outdated, multi-layered rulemaking process. This caused a large OTC Monograph backlog in which product labels could take years to update. As a response to this, included in the CARES Act, (implemented into law on March 27, 2020) is a major piece of federal legislation that amends the FD&C Act to modernize the OTC drug review and OTC monograph drug development process, essentially by removing...

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How to Register a Hand Sanitizer Product in the US

How to Register a Hand Sanitizer Product in the US

Due to the COVID-19 pandemic, world-wide demand has soared for hand sanitizer and anti-viral products. Below, we outline five basic steps for domestic and foreign manufacturers or domestic distributors who want to get their drug product into the US market but never dealt with the FDA’s electronic drug registration and listing. The scope of products includes: Rx (Prescription Drugs) and OTC (Over the counter) – ex. Hand Sanitizer, API’s (active pharmaceutical ingredients) and homeopathic, herbal and dietary supplements. Who is responsible to for Drug registration and Drug listing?  The manufacturer is primarily responsible; however, the Drug importer and/or distributor also has the responsibility for Drug registration. The five process steps for Drug registration and Drug listing : Does your firm have a Duns & Bradstreet (DnB) number (or DUNS number)? If no- go to www.dnb.com where you can initiate the registration  for free if located in the US and not time restricted.  Obtaining a DUNS number for a foreign firm may take time.Next step, register with FDA for a...

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Our Core Team

Our experts are tireless and dedicated to delivering results.

Glen Feye, MS, and CQE

Glen Feye, MS, and CQE

Accurate FDA Consultants President and Founder

Dilip Ashtekar, Ph.D.

Dilip Ashtekar, Ph.D.

Barney King, MD, MBA

Executive Regulatory and Clinical Consultant

Mario Gemar, PhD.

RA/QA Consultant

Sebastian Feye, BSC

Sebastian Feye, BSC

RA Manager