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’);//]] ’);//]] ’);function WebForm_OnSubmit() { null; return true; } //]](Press Enter). Log in Toggle navigation Search Options Log in Home Communities All Communities My Communities Regulatory Open Forum Regional Communities RAC Prep Community Events Volunteer My Volunteer Profile Volunteering with RAPS Volunteer Opportunities Mentoring RAPS Mentoring Program RAPS.org See what’s new in the Regulatory Open Forum RE: Extension of Shelf Life Posted by: Jacqueline Marchionne , 49 minutes ago Discussion Found in: Regulatory Open Forum Discussions If no 510k would a Note to File would be required?Jacqueline Marchionne Boston MA United StatesRE: Logo change Vs Name Change for FDA establishment registration Posted by: Kristen Kanack , 50 minutes ago Discussion Found in: Regulatory Open Forum Discussions Dear Anon, If the company has retained its legal name, then no, the logo change is not a "Name Change’ for FDA establishment registration purposes. However, the parent company may wish to put the acquired read more RE: Brazil- Regulatory Requirements for Importation Posted by: Kayla Maue , an hour ago Discussion Found in: Regulatory Open Forum Discussions Hi Imtiyaz, We can support you with drug product submissions and navigating regulatory requirements. Cencora PharmaLex is one of the largest global regulatory solutions providers for Pharma, Biotech, read more RE: IQ/OQ/PQ Posted by: Kayla Maue , an hour ago Discussion Found in: Regulatory Open Forum Discussions Hi Anon, We can support you with process validation for medical device manufacturing. Cencora PharmaLex is one of the largest global regulatory solutions providers for Pharma, Biotech, and MedTech companies, read more RE: Why there is a k number when the device code is 510(k) exempt? Posted by: Kevin Randall , 2 hours ago Discussion Found in: Regulatory Open Forum Discussions Generally speaking, this means that the subject device previously required a 510(k), but then FDA later (such as via the 21st Century Cures Act) down-graded the category into a 510(k)-exempt class. For read more More View this profile on Instagram RAPS (@ regulatoryprofessionals ) • Instagram photos and videos Unanswered posts Most Recent Most Rated SAHPRA South Africa Unresponsive By: Vanessa Isla , 4 hours ago Posted in: Regulatory Open Forum Is anyone else experiencing unresponsiveness from SAHPRA? We submitted an amendment to our CTA in early March and have followed up via email and phone several times. Unfortunately, we had no luck with connecting with anyone from SAHPRA. This type of ... Confirmation letter & extension period MDD/MDR By: Anonymous Member , 6 hours ago Posted in: Regulatory Open Forum This message was posted by a user wishing to remain anonymous Dear all, We are distributing medical devices (class IIa) which are CE marked and manufactured by another manufacturer. The products are approved under MDD and very recently their CE ... Europe too, Unhappy with China’s Device Procurement ... By: Ames Gross , 18 hours ago Posted in: Regulatory Open Forum Over the last 5 years, relations between the US and China have been deteriorating, while EU-China relations have held relatively steady. However, recently China-EU relationships have begun to deteriorate too. One example of this is an EU investigation ... 1 person recommends this. Label: "Legal entity name" Vs "Company name" By: Anonymous Member , 6 hours ago Posted in: Regulatory Open Forum This message was posted by a user wishing to remain anonymous We are a small manufacturing company which is part of a slightly larger company. Our company has a "Name", however, following an acquisition process, it was registered under another "Legal ... RAPS Philly - June Event Alert! By: Amanda Pentecost , yesterday Posted in: Regulatory Open Forum Hello RAPS members, We welcome you to join RAPS Philly on Wednesday, June 12 from 12-1 PM (EST) for a virtual lunch and learn presentation and discussion with Kalpana Venkataraman of Opus Regulatory Inc. who will be presenting Target Product ... 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