US FDA publishes FAQs and has announced the availability of temporary guidance for industry entitled, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections during COVID-19 Public Health Emergency Questions and Answers.
It is recognized that the COVID-19 public health emergency is not only impacting public health, but also drug development programs, ongoing manufacturing operations and FDA’s ability to conduct inspections. We also recognize sponsors and applicants have many questions related to this impact. The agency developed this guidance to provide answers to a number of frequently asked questions”, informed the drug regulator in a statement.
The Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Office of Regulatory Affairs remain fully capable of continuing daily activities, such as application assessments, including facility evaluation and certain inspection activities, while responding to public health needs related to the current COVID-19 public health emergency. As this remains an evolving and very dynamic situation, we will continue to be flexible and transparent, it added further.
The US FDA publishes FAQs in August, answering questions about registering, listing, and importing medical devices during the COVID-19 emergency. Our team provide solutions and guidance for any registration, FDA 510(k) clearance for medical devices or if a manufacturer wants to set up plant in India, we consultation for CDSCO registration .These should be useful to manufacturers and other interested parties, not only because of the question-and-answer format, but because they provide links to numerous other FDA guidance documents published during the pandemic and related online resources.
US FDA publishes FAQs Registering and listing medical devices and facilities.
The first FAQ describes requirements and approved procedures for registering and listing medical devices and facilities during the COVID-19 pandemic. It includes an explanation of how to confirm registration and listing information, and it also provides recommendations and guidance documents relevant to operations during the present public health emergency. The FAQ addresses topics such as how long it takes for a facility to receive its registration number, when registration is not required, and how to evaluate claims of FDA “certification.” The section headings are as follows:
- Registration and Listing During the COVID-19 Pandemic
- Confirming Registration and Listing Information
- Registration and Listing of Certain Medical Devices for Use during the Emergency.
US FDA publishes FAQs Importing medical devices
The second FAQ looks at importing medical devices amidst the COVID-19 emergency. It addresses importation of specific devices that have been issued with Emergency Use Authorizations (EUAs) and devices for which an enforcement decision has been published in a guidance document. This FAQ also includes detailed instructions for donating medical devices, checking import status, evaluating FDA “certification” claims, and identifying contacts for import questions. Section headings are:
- Importing Respirators, Face Masks, and PPE
- Donating Medical Devices
- Importing Other Medical Devices
- Checking Import Status and Contact for Import Questions
The FDA describes the way the medical devices actively used in the context of the pandemic could be imported to the US, and also the requirements the importer shall fulfill. The most important points covered by the US FDA publishes FAQs include, inter alia, the following ones:
The FDA does not certify products – the Agency only allows products for marketing and use and adds the appropriate entries to the register. In order to check whether the particular product is FDA-cleared, the interested party may check the databases containing information about the registered medical devices and ones covered by device-specific exemptions. It is also advised to check the information about the devices placed on the market under the appropriate EUA. Sterilizers could be imported under the special enforcement policy issued by the FDA. For devices of this type, the FDA is not going to object to certain changes.
In order to import ventilators covered by the EUA, the importer shall supplement the importation documentation with the signed EUA letter. Depending on the particular ventilator in question, the appropriate Intended Use Code (IUC) should be indicated by the importer.
Electronic thermometers could be also placed on the market under the special enforcement policy which simplifies regulatory procedures related to such devices due to the important role they are playing in addressing the COVID-19 outbreak. In particular, in some cases, thermometers could be marketed without registration and listing.
Remote ophthalmic assessment and monitoring devices could be imported under the simplified procedure too, providing that the appropriate Intended Use Code has been indicated.
Infusion pumps and accessories thereto are also covered by the special enforcement policy allowing the importers and manufacturers of such devices to waive certain regulatory requirements related to the registration and listing.
COVID-19 tests, which are regulated as in vitro diagnostic medical devices, could be imported either under the Emergency Use Authorization or under the special policy for diagnostic tests for corona virus intended to be used in the context of the public health emergency. Thus, the appropriate Intended Use Code should be indicated in the importation documentation. Each imported medical device regulated by the FDA should be assigned with the appropriate entry number.
According to the general rule, the entity performing operations with medical devices should be duly registered with the FDA. In the course of such registration, an entity should describe the operation it performs and to provide a list of medical devices. In case if due to the type of the device in question should be subject to mandatory pre-market approval, the interested party shall submit the appropriate application to the FDA. Each entity shall also pay the annual registration fee irrespectively of the applications filed.
Reference – https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-august-11-2020
