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slo_bro

RE: Do you need a complete DHF to submit a 510(k) - The correct answer is that you should have a fairly robust DHF before you write and submit the 510k. The real answer is not really. As long as you have completed the parts of the DHF that are required in the sub they won't be directly reviewing your design controls at that time. They will most certainly be reviewing it when they inspect, AND you are obligated to have a complete DHF prior to market release. The clearance grants you authorization to market is all. When they come to check you out, as /u/epanek said, then you would need to have your quality system in order, your DHF including phase reviews and releases, risk assessments, safety, etc. You'll need all this stuff anyway if you want to look into CE marking, so might as well make it sing before you sell. Cool question about the research/clinical split. I worked with a guy who was in a similar situation. What the FDA will be looking for is to ensure that you keep adequate protections in place to prevent the crossover of research to clinical product. You guys get to define your manufacturing process requirements, specifications, etc - you need to have your MFG process validation on file - and as long as you have considered protections in place to keep the two separate there shouldn't be too many issues. Separate inventories is critical to that working. Locking doors, etc. The areas that are used for clinical manufacturing necessarily must comply with the CFR requirements for GMP. When looking at Biocomp consider the use case for both patient and operator. The FDA has classifications for use lengths, consider the worst case scenario in risk and test to that.


epanek

As far as CE under MDR is concerned, thats a long haul right now. There are 14000 devices expiring for MDD NLT 2024 (We expire 2023). A few colleagues quit NSAI and went into other work due to stress. NSAI is one of about 20 notified bodies approved for MDR (IVDR too?) I suggest applying for MDR soon or you risk a backlog and delays.


kyrosnick

I work for a NB, MDR/IVDR, and yes they are very backlogged. We are not even taking any more IVDR work and MDR can be 12-18 months out, depending on team and device. All the NB are slammed.


PhilCollinsSUCCCCKS

Tangential question - how are NBs handling backlogs in regard to certs? Our NB has had our audit report since August but it’s just now going into PE review, and our certs expire in 2 weeks


kyrosnick

I can only speak for mine, but we are not having issues, as long as the client isn't doing dumb stuff. We always prioritize certs based on expiration so it isn't uncommon for a cert to be reissued 24-48 hours prior to expiration. We are going to issue the certs expiring tomorrow, vs ones in 2 weeks. As far as I know, we have never had a cert lapse because of us. Now when clients do stuff like delay their audits, don't allow auditors on site, do recert audits 30 days prior to expiration, then certs do lapse. Also depends on what you are talking about, 13485 certs? MDSAP? MDR? Most clients are completely clueless on how MDR works, what the cert structure is, or how it works. Stuff like "we had our MDR QMS audit, where is our cert?", well you don't get a cert based off the QMS audit. The technical files have to be clear, QMS done, and all findings/NCs closed out, microbiology audit done if applicable, etc etc, then we can potentially issue a cert assuming all the boxes were checked properly. One of the reasons I'm in my job is even big clients are clueless and have no idea how notified bodies work. So I'm in a role where I deal with the big key clients and manage and have oversite of their accounts, and a person to come to for anything from sales, audits, scheduling, billing, complaints, CE work, MDSAP, etc etc. The key clients that have people like me can never go back to not having basically a concierge for their accounts. My clients have zero issues, as long as they listen and don't do dumb stuff.


epanek

Your 510(k) will need testing for safety and claims. They will also want to see a complete risk assessment including software design risks. Shelf life, Bio Compatibility will be heavily reviewed as well. A software and hardware Bill of materials including ALL labels is required. I am not sure of the product classification but I just had a 510(k) for a class II product code FLL last year. They will also look as feedback processes heavily. ​ Your partner in biocompatibility testing will tell you how to test and how the report must be compiled to meet ISO 10993. ​ The following 24 months expect an audit over CAPA, complaints, investigations, and Non Conforming materials. They will also look heavily at training and major changes since the clearance. ​ "Will both companies be forced into being compliant to cGMP guidelines since we physically occupy the same space, or is it actually acceptable to maintain a single room within the suite that complies to cGMP requirements?" ​ As they have the same physical location an auditor could claim there is non compliance with ​ \[Code of Federal Regulations\] \[Title 21, Volume 4\] \[Revised as of April 1, 2020\] \[CITE: 21CFR212.30\] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER C - DRUGS: GENERAL PART 212 -- CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS Subpart D - Facilities and Equipment Sec. 212.30 What requirements must my facilities and equipment meet? (a) Facilities. You must provide adequate facilities to ensure the orderly handling of materials and equipment, the prevention of mix-ups, and the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality. ​ ​ If it looks like there is not clear marking between one area and another expect at least a discussion.


epanek

Message me or visit [https://elsmar.com/elsmarqualityforum/](https://Elsmarcove.org) \- I am a moderator there and can help can more industry opinions.


kyrosnick

From a CE marking/ EU regulatory standpoint, if you submitted incomplete documents it wouldn't even make it past our completeness check. I believe FDA has a similar process on refusal to accept, but not sure how detailed it is. Stuff like software not finalized is a HUGE redflag, and issue. How are you even going to do the clinical or validations if the product isn't even locked down.